Skin and tissue bank: Operational model for the recovery and preservation of tissues and skin allografts

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Tel.: +52 (55) 5999 1000 ext.14802." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Banco de piel y tejidos: un modelo operativo para la recuperación y preservación de aloinjertos de piel y tejidos" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1644 "Ancho" => 3000 "Tamanyo" => 244328 ] ] "descripcion" => array:1 [ "en" => "Operational model of the Skin and Tissue Bank of the Instituto Nacional de Rehabilitación. H, hospital; INNyN, Instituto Nacional de Neurología y Neurocirugía; MVS, Manuel Velasco Suarez." ] ] ] "textoCompleto" => "BackgroundAlthough several primitive attempts to carry out transplants were rudimentarily described almost 2500 years ago, in the so-called “Sutrasthanam manuscripts”,<a class="elsevierStyleCrossRef" href="#bib0105">1</a> where they appeared as an incipient surgical procedure against the damage caused to the bodies of soldiers, it was not until the beginning of the 20th century that the first documented processes were reported regarding the use of tissues preserved at low temperatures over several days and subsequently replanted into the same donor.<a class="elsevierStyleCrossRef" href="#bib0110">2</a>The Luyet<a class="elsevierStyleCrossRef" href="#bib0115">3</a> and Webster<a class="elsevierStyleCrossRef" href="#bib0120">4</a> studies documented freezing as an effective method for the temporary preservation of tissues. In accordance with Wright et al.<a class="elsevierStyleCrossRef" href="#bib0125">5</a> Falt and Marragonni reported the first storage procedures of skin from dead bodies using solutions supplemented with 10% serum as a preserving agent.<a class="elsevierStyleCrossRefs" href="#bib0125">5,6</a> All these steps led to the creation of a new type of establishment from the end of the 1980s, equipped to store skin and other tissues. These installations were latterly known by their generic name as “skin banks”.The use of human allografts is closely related to the development of different methods for the preservation of tissues (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). These strategies are designed to integrate tissue recovery procedures which seek: (1) cellular viability maintenance<a class="elsevierStyleCrossRef" href="#bib0135">7</a>; (2) the preservation of proteins<a class="elsevierStyleCrossRef" href="#bib0140">8</a>; (3) the presence of growth factors such as: the epidermal growth factors, the vascular endothelial growth factor, the transforming growth factor beta and pro-inflammatory cytokines (Il-2, Il-6, Il-10 TNF-α alfa); and (4) the complete integrity of tissues. All these factors focus on generating biological products of high quality, with top health safety and of extreme therapeutic value.<a class="elsevierStyleCrossRef" href="#bib0145">9</a><elsevierMultimedia ident="tbl0005"></elsevierMultimedia>The procurement and preservation of tissues is a rapidly and increasingly developed activity which is positively correlated with technological and scientific advances present in biomedical sciences during the 20th century. Furthermore, demand for allografts for therapeutic reasons is projected to increase considerably as a result of the increase in life expectancy and its concomitant increase in chronic degenerative diseases. The design of successful institutional strategies capable of promoting donation activities and tissue retrieval<a class="elsevierStyleCrossRefs" href="#bib0150">10–12</a> has therefore become imperative.The aim of our study consisted of describing the current panorama of tissue retrieval and storage with the design of a prototype institutional model authorised by the Banco de Piel y de Tejidos del Instituto Nacional de Rehabilitación (INR) for retrieval and storage of high therapeutic value, thanks to the use of scientific principals applied to self sustainability of the health system needs in Mexico.Worldwide regulation of skin banksSeveral international associations which promote protocols and directives for the technical operation of skin and tissue banks<a class="elsevierStyleCrossRefs" href="#bib0165">13–16</a> were created in order to organise establishment and operations. The following are of note: (1) American Association of Tissue Banks, created in 1972; (2) Euroskin Bank (Bewerjwick, NL) founded in 1976 and called Tissue Bank from 2010; (3) European Association of Tissue Banks, established in 1991; (4) Asociación Española de Bancos de Tejidos, founded in 2002; (5) Asociación de Bancos de Tejidos de Asia-Pacífico; and (6) la Asociación Latinoamericana de Bancos de Tejidos.All these organisations try to regulate the standardisation of directives for the therapeutic storage and use of tissues for transplant, in conjunction with other governmental, ethical and scientific bodies. The following central points may be highlighted from the international standards: (1) ethical aspects regarding the procurement of tissues based on altruism and not trading; (2) regional regulation of prevailing health laws; (3) administrative organisation; (4) standards for physical installations of tissue banks; (5) recuperation of tissues with pharmaceutical quality and standards; and (6) traceability of preservation processes.Tissue banks in MexicoIn the Mexican Republic initial activities related to tissue storage were made with bone material. Pioneering procedures took place in the Hospital Central Militar and the Hospital Infantil de México in 1944. During the 1950s similar activities were initiated in Hospital Rubén Leñero and in Hospital Regional de Monterrey.In 1997 the Hospital Central de Petróleos Mexicanos and the Universidad Nacional Autónoma de México carried out several procedures relating to tissue storage, using the then available international standards. The Banco de Tejidos of the Instituto Nacional de Investigaciones Nucleares (ININ) is prominent here as it began to use gamma radiation to sterilise bone tissues, pig hide and amniotic membranes.Activities in Skin and Tissue Banks today involve the procurement, processing, storage and distribution of biological products classified by the current Ley General de Salud as “biological supplies” as they include an industrialisation process which guarantees their safety and efficacy.On 30th January 2013 the national register of the Centro Nacional de Trasplantes recorded 56 establishments classed as Banks, which were regulated jointly with the Comisión Federal de Protección contra Riesgos Sanitarios (COFEPRIS).Legal framework of tissue banks in MexicoThe Sistema Nacional de Trasplantes (SNT) is a structure located within the Sistema Nacional de Salud, consisting of all the establishments and hospitals possessing a licence to carry out organ or tissue donor transplant activities and cell or tissue bank activities authorised by COFEPRIS. All these bodies are subject to the regulations established by law and specifically that laid down in Title XIV of Ley General de Salud, in the legal regulations issued on these matters and other directives.<a class="elsevierStyleCrossRef" href="#bib0165">13</a>In compliance with prevailing legislation, the Skin and Tissue Bank of the Instituto Nacional de Rehabilitación is authorised to offer organs, tissues and cells for transplant, through organ, tissue extraction, skin and muculoskeletal tissue transplant, and also a tissue bank (skin and musculoskeletal tissue). The legal context enables the Skin and Tissue Bank to have an innovative and far-reaching approach in its procedures model for procurement, preservation and transplant of tissues for therapeutic purposes. This approach includes social aspects for the promotion of an organ and tissue donor culture and the training of highly specialised human resources in donor and tissue preservation matters.The transplant Committee as a regulating body of Mexican bank activitiesThe corner stone of the SNT are the Internal Transplant Committees in each hospital. In compliance with article 316 of the Ley General de Salud, these collegiate bodies comprise a health care director and a group of health professionals who are experts in this sector, coordinators in donation and transplant, and the necessary administrative support staff for these procedures.<a class="elsevierStyleCrossRefs" href="#bib0165">13,17</a>Although in the strict sense of the word, the main function of a bank is to safeguard tissues until use, this activity should be secondary to the development of preservation activities with traceability of transparency and safety for operators and users. The supervision of these activities was entrusted to the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS).Problems with skin and tissues banks in MexicoDue to the existing lag in adopting this type of establishment the following problems arise in Mexico: (1) there is little experience in the practise of tissue storage; (2) a high learning curve exists and high costs associated with specific training in this area; (3) there is no active training and educational programme for the culture of organ and tissue donation; (4) no integrated model of donation, procurement and cadaveric skin processing exists within the Sistema Nacional de Salud; (5) there is very little financial investment in scientific research aimed at tissue storage; (6) there are problems derived from current legislation and classification of biological tissues as “supplies” in the Ley General de Salud; (7) private companies are competing for tissue donation; (8) the health sector lacks any industrial development for the generation of supplies; (9) ethical problems arise derived from private banks competing for donors, through practices which lack sufficient regulation.The Skin and Tissue Bank of the Instituto Nacional de Rehabilitación as a prototype model for the recuperation of tissuesSince March 2009, the Skin and Tissue Bank of the Instituto Nacional de Rehabilitación has been the Ministry of Health's leading tissue bank in tissue storage, within the framework of National Health Institutes. Its mission is to be a centre of excellence in the procurement, processing and storage of skin and other tissues, through the development of a model based on scientific research, the use of new biomedical and molecular state-of-the-art technologies and the education and training of highly specialised human resources.In addition, the bank provides specialised surgical assistance for the obtention of tissues in procurement hospitals or those generating procurement, as well as their use in allogenic tissue implantation programmes. At the same time it develops donor culture awareness and outreach campaigns.The bank reiterates the directives and principles established by the Centro Nacional de Trasplantes with the introduction of 5 essential ethical principles: voluntary donation, altruism, solidarity, confidentiality and information.Standards of the Skin and Tissue Bank for the harvesting of skin and tissue allografts for use in transplantsThe model followed by the Skin and Tissue Bank of the and Instituto Nacional de Rehabilitación is based on complete integration of the phases involved in the tissue donation and transplant system, with traceability outlined for the procedures in line with ISO-9000-2008 (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>) regulation.<elsevierMultimedia ident="fig0005"></elsevierMultimedia>HarvestingThe procedure for obtaining skin and tissues is made through inter-institutional collaboration with different transplant programmes which meet the criteria established for organ and tissue donation (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>). Tissue harvesting is currently defined as a surgical event (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>) and as such quality standards for skin recovery surgery must therefore be adhered to.<a class="elsevierStyleCrossRef" href="#bib0190">18</a><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia>Once informed consent has been obtained from the multiple organ donor's family and cardiac arrest meets with inclusion criteria (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>), in the specific case of skin surface area disinfection processes are carried out based on iodine and alcohol solutions in different concentrations (70–100%), in a surgical area with an aseptic technique.<elsevierMultimedia ident="tbl0015"></elsevierMultimedia>Recovery and preservationThe concept of recovery focuses on reversing or as much slowing down as possible of cell death, induced by tissue hypoxy and the depletion of nutrients, after the last heartbeat. To do this the tissues are stored in solutions formulated with a physiological pH (7.4) and with buffering agents in the presence of essential nutrients and antibiotics to begin the process of microbial decontamination. Medium term preservation is achieved using cryopreserving solutions and pH stabilisers which enable the tissue to be maintained at a temperature below −80°C. The formulation of these materials is carried out in the preparation laboratory of the tissue and skin bank itself, in keeping with the good manufacturing practice and good laboratory practice, and are sterilised by filtration.Microbiological quality certificationThe biological quality of the tissues and the microbiological certification are essential standards for tissue preservation. The standard for aerobic, anaerobic and fungal microorganisms identification is to take readings at 7, 14 and 21 days under specific mediums.<a class="elsevierStyleCrossRef" href="#bib0195">19</a> The microbiological control system is used in tissue quality control protocols, with the use of solution to maintain contact with the recuperation and preservation process (<a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>).<elsevierMultimedia ident="fig0015"></elsevierMultimedia>Molecular biology techniques for identification of pathogen agent identificationThe gold standard in identifying pathogens is carried out with the identification of genomic segments using the polymerase chain reaction technique (PCR). This technique which was described by Kubista Mullis and his team<a class="elsevierStyleCrossRef" href="#bib0200">20</a> has a sensitivity rate of 1×10−7; i.e. it is able to identify an infected cell for every 1×107 healthy cells. In the case of certification protocols, the tests which the banks perform are made in real time, searching for the human immunodeficiency virus types 1 and 2, hepatitis B and C; cytomegalovirus and Treponema pallidum. Given that the technique is highly specific and sensitive, tests are made in triplicate in a sterilised area and safety cabinet with laminar flow type II-AB. These tests are validated for diagnostic and clinical use in humans and include internal controls (calibrated as negative and positive) for each test with a search in donor blood and tissue (<a class="elsevierStyleCrossRef" href="#fig0020">Fig. 4</a>).<a class="elsevierStyleCrossRefs" href="#bib0130">6,20</a><elsevierMultimedia ident="fig0020"></elsevierMultimedia>Physical infrastructureAt present the bank consists of 5 laboratories, which meet with class 100 regulations and operate according to good manufacturing practice and good laboratory practice. Since this is a national reference centre, the bank used its physical infrastructure meeting with directives from the Federación Española de Bancos de Tejidos and the Asociación Europea de Bancos de Tejidos. It is physically structured according to 3 main areas<a class="elsevierStyleCrossRef" href="#bib0150">10</a>: (1) class 100 inner chamber; (2) administrative area; and (3) support and research areas.Class 100 inner chamber structureLaboratory for the preparation of materialsEquipment and materials for the preparation of cleansing, decontamination and maintenance solutions at constant temperature (18°C), filtered air (class 100) and positive pressure.Quarantine laboratoryClean room with constant temperature (18°C), filtered air (class 100) and positive pressure for recovery and decontamination of tissues. Refrigerators for maintaining a constant temperature (4°C) in decontamination processes. Class IIAB biological safety cabinet for handling tissue.Processing laboratory for musculoskeletal tissueDouble-chamber clean room insulated with a constant temperature, filtered air (class 100) and positive pressure aimed at the recovery, cutting and decontamination of musculoskeletal tissue.Packaging laboratoryClean room with constant temperature (18°C), filtered air (class 100) and positive pressure, for final tissue packaging prior to being sent for final freezing. The processes are carried out in a class IIA-B biological safety cabinet for tissue handing. The inner chamber connects with an area for tissue storage and safekeeping.Tissue storage and safekeeping area (deep freezing)Restricted access area for tissue storage with temperature support systems, monitoring system in real time for temperature recording and a televised surveillance system. Constant temperature (18°C) and class 100 filtered air.Equipment and Sterilisation Centre (CEYE)Equipment and supplies for validating sterilisation processes of materials and equipment used in procurement processes.Administrative areaDesigned outside central facilities and with restricted access.Support and research areasConstituted by a laboratory of multiple uses and with a culture chamber, for the development of research protocols relating to the formulation of materials, cellular death blockage mechanisms and cryobiotic molecular strategies for the purpose of transplants.Discussion and perspectivesIn keeping with the worldwide trend to recuperate tissues for therapeutic uses, the storage of skin and other tissues in the context of healthcare needs and current Mexican medical research several of the following points must be precisely defined to obtain a better therapeutic outcome:Conceptualise the procurement and harvesting of tissues as a surgical eventThis point necessitates a change in the conceptualisation of the obtainment of tissues as a surgical event, with particular emphasis on quality, as recently described in detail in the lasts amendment to the Ley General de Salud, relating to the regulation governing organs and tissues (12th December 2011).Defining the type of procedure used in preservationEach method (chemical decontamination, lyophilisation, gamma sterilisation) has a different effect on the biological, physical and chemical characteristics of the tissue (cellular viability index, loss of water, of elasticity and resistance), and finally, in its posterior usage. In our model the preliminary data indicate that the biological recuperation of tissues represents the method with the best therapeutic outcome, following a long period of freezing at temperatures below 80°C below zero (<a class="elsevierStyleCrossRef" href="#fig0025">Fig. 5</a>).<elsevierMultimedia ident="fig0025"></elsevierMultimedia>Traceability of processesDocumentation of each phase of procurement, preservation and liberation of tissue, respecting privacy and confidentiality data.The traceability of processes must document the critical route of each process and include essential documents such as: (1) manual for specific procurement procedure; (2) manual for specific procedure for recuperation and preservation of tissues; (3) manual for microbiological control and specific tissue quality; (4) procurement protocol for tissue procuring hospitals; (5) clinical files and service formats (microbiological, molecular laboratory, pathology, etc.); (6) manual and records of preventative maintenance of equipment and installations; (7) registry and control of access for general services and microbiological records of environmental controls; and (8) registry and report of activities sent to the Centro Nacional de Trasplantes.In addition, the following lines of action may have a serious impact on the growth of tissue bank activity:Integration and growth of a hospital network for increasing regional tissue affluenceEstablishing a network for the procurement of tissues involves carrying out a large number of collaboration agreements in tissue procurement matters, for transplant in other hospital institutions, for the purpose of increasing the identification of potential tissue donors.Implementation of a research programme in tissue pharmaceutical cryobiotics with therapeutic usesThe aim of this is to promote the design of procurement and cryopreservation protocols for skin and tissues, and also to foster the broadening of scientific research to reduce dependency on imported materials and promote self-sustainability of operations, focused on: (1) scientific procedures for preservation and tissue cryobiology aimed at obtaining high quality biological and therapeutically effective products; (2) generation of materials and patents for the bank's self sustainability; and (3) scientific dissemination of processes used in other institutions.Implementation of an academic surgical training programme for tissue procuratorsArranging the registration and execution of multi-tissue procurator courses, endorsed by both academic institutions and the Centro Nacional de Trasplantes In Mexico to form specialised and highly trained personnel. Furthermore, to include specific modules on the surgical procedures involved in tissue procurement and transplant in pre-grade modules study programmes.Advocacy of a more widespread cadaveric skin donation cultureDriving the training programme for leaders who will be the promoters of the culture of organ and tissue donation in collaboration with non-governmental organisations and mass media communication campaigns, with use of social networks and internet.Last but not least, several ethical considerations have to be readdressed, starting with the fact that the obtainment of tissues is an act of altruistic donation with no profit making or commercialisation and process recuperation quotas must therefore be regulated and defined; this point is also being addressed by the World Health Organisation.The coordination and integration of the organ and tissue donation and transplant programmes must be carried out with functional, responsible and equitable participation from areas of research, human resources training and health care services.This model is merely one of the medium term proposals to modify the current tissue recovery setting. Possibly in a couple of decades, similarly to the Spanish model it could become the world leader of organ and tissue donor programmes.FinancingThis study was financed by the Council for Science and Technology through the Fondos Sectoriales de Investigación in Salud CONACYT-FOSIS 2011-1-161624.Conflict of interestsThe authors have no conflict of interests to declare." "textoCompletoSecciones" => array:1 [ "secciones" => array:9 [ 0 => array:3 [ "identificador" => "xres611331" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec625360" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres611332" "titulo" => "Resumen" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec625359" "titulo" => "Palabras clave" ] 4 => array:3 [ "identificador" => "sec0005" "titulo" => "Background" "secciones" => array:13 [ 0 => array:2 [ "identificador" => "sec0010" "titulo" => "Worldwide regulation of skin banks" ] 1 => array:2 [ "identificador" => "sec0015" "titulo" => "Tissue banks in Mexico" ] 2 => array:2 [ "identificador" => "sec0020" "titulo" => "Legal framework of tissue banks in Mexico" ] 3 => array:2 [ "identificador" => "sec0025" "titulo" => "The transplant Committee as a regulating body of Mexican bank activities" ] 4 => array:2 [ "identificador" => "sec0030" "titulo" => "Problems with skin and tissues banks in Mexico" ] 5 => array:2 [ "identificador" => "sec0035" "titulo" => "The Skin and Tissue Bank of the Instituto Nacional de Rehabilitación as a prototype model for the recuperation of tissues" ] 6 => array:2 [ "identificador" => "sec0040" "titulo" => "Standards of the Skin and Tissue Bank for the harvesting of skin and tissue allografts for use in transplants" ] 7 => array:2 [ "identificador" => "sec0045" "titulo" => "Harvesting" ] 8 => array:2 [ "identificador" => "sec0050" "titulo" => "Recovery and preservation" ] 9 => array:2 [ "identificador" => "sec0055" "titulo" => "Microbiological quality certification" ] 10 => array:2 [ "identificador" => "sec0060" "titulo" => "Molecular biology techniques for identification of pathogen agent identification" ] 11 => array:2 [ "identificador" => "sec0065" "titulo" => "Physical infrastructure" ] 12 => array:3 [ "identificador" => "sec0070" "titulo" => "Class 100 inner chamber structure" "secciones" => array:8 [ 0 => array:2 [ "identificador" => "sec0075" "titulo" => "Laboratory for the preparation of materials" ] 1 => array:2 [ "identificador" => "sec0080" "titulo" => "Quarantine laboratory" ] 2 => array:2 [ "identificador" => "sec0085" "titulo" => "Processing laboratory for musculoskeletal tissue" ] 3 => array:2 [ "identificador" => "sec0090" "titulo" => "Packaging laboratory" ] 4 => array:2 [ "identificador" => "sec0095" "titulo" => "Tissue storage and safekeeping area (deep freezing)" ] 5 => array:2 [ "identificador" => "sec0100" "titulo" => "Equipment and Sterilisation Centre (CEYE)" ] 6 => array:2 [ "identificador" => "sec0105" "titulo" => "Administrative area" ] 7 => array:2 [ "identificador" => "sec0110" "titulo" => "Support and research areas" ] ] ] ] ] 5 => array:3 [ "identificador" => "sec0115" "titulo" => "Discussion and perspectives" "secciones" => array:7 [ 0 => array:2 [ "identificador" => "sec0120" "titulo" => "Conceptualise the procurement and harvesting of tissues as a surgical event" ] 1 => array:2 [ "identificador" => "sec0125" "titulo" => "Defining the type of procedure used in preservation" ] 2 => array:2 [ "identificador" => "sec0130" "titulo" => "Traceability of processes" ] 3 => array:2 [ "identificador" => "sec0135" "titulo" => "Integration and growth of a hospital network for increasing regional tissue affluence" ] 4 => array:2 [ "identificador" => "sec0140" "titulo" => "Implementation of a research programme in tissue pharmaceutical cryobiotics with therapeutic uses" ] 5 => array:2 [ "identificador" => "sec0145" "titulo" => "Implementation of an academic surgical training programme for tissue procurators" ] 6 => array:2 [ "identificador" => "sec0150" "titulo" => "Advocacy of a more widespread cadaveric skin donation culture" ] ] ] 6 => array:2 [ "identificador" => "sec0155" "titulo" => "Financing" ] 7 => array:2 [ "identificador" => "sec0160" "titulo" => "Conflict of interests" ] 8 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2014-10-16" "fechaAceptado" => "2014-12-16" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec625360" "palabras" => array:4 [ 0 => "Tissue bank" 1 => "Skin allografts" 2 => "Quality control" 3 => "Tissue recovery" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec625359" "palabras" => array:4 [ 0 => "Banco de tejidos" 1 => "Aloinjertos de piel" 2 => "Control de calidad" 3 => "Recuperación de tejidos" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "Tissue storage is a medical process that is in the regulation and homogenisation phase in the scientific world.The international standards require the need to ensure safety and efficacy of human allografts such as skin and other tissues. The activities of skin and tissues banks currently involve their recovery, processing, storage and distribution, which are positively correlated with technological and scientific advances present in current biomedical sciences.A description is presented of the operational model of Skin and Tissue Bank at Instituto Nacional de Rehabilitación as successful case for procurement, recovery and preservation of skin and tissues for therapeutic uses, with high safety and biological quality. The essential and standard guidelines are presented as keystones for a tissue recovery programme based on scientific evidence, and within an ethical and legal framework, as well as to propose a model for complete overview of the donation of tissues and organ programmes in Mexico. Finally, it concludes with essential proposals for improving the efficacy of transplantation of organs and tissue programmes." ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "El almacenamiento de tejido es un proceso médico en fase de regulación y homogenización científica en el mundo. Los estándares internacionales exigen garantizar la seguridad y la eficacia de los aloinjertos humanos como piel y otros tejidos. En la actualidad las actividades de los bancos de piel y tejidos involucran la recuperación, procesamiento, almacenamiento y distribución como proceso de desarrollo, que se correlaciona positivamente con los avances tecnológicos y científicos presentes en las ciencias biomédicas actuales.Se describe el modelo instaurado por el Banco de Piel y de Tejidos del Instituto Nacional de Rehabilitación como un caso exitoso para la procuración, recuperación y preservación de piel con fines terapéuticos, alta seguridad sanitaria y elevada calidad biológica. Se discuten los fundamentos y estándares empleados en el programa actual de recuperación de tejidos con base en la evidencia científica disponible, el contexto ético y el marco jurídico vigente de la donación de tejidos en México. Se concluye con algunas propuestas para mejorar la eficacia de los programas de trasplantes." ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Francisco Martínez-Flores F, Sandoval-Zamora H, Machuca-Rodriguez C, Barrera-López A, García-Cavazos R, Madinaveitia-Villanueva JA. Banco de piel y tejidos: un modelo operativo para la recuperación y preservación de aloinjertos de piel y tejidos. Cir Cir. 2016;84:85–92." ] ] "multimedia" => array:8 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1644 "Ancho" => 3000 "Tamanyo" => 244328 ] ] "descripcion" => array:1 [ "en" => "Operational model of the Skin and Tissue Bank of the Instituto Nacional de Rehabilitación. H, hospital; INNyN, Instituto Nacional de Neurología y Neurocirugía; MVS, Manuel Velasco Suarez." ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 749 "Ancho" => 995 "Tamanyo" => 110940 ] ] "descripcion" => array:1 [ "en" => "Surgical procurement of skin." ] ] 2 => array:7 [ "identificador" => "fig0015" "etiqueta" => "Figure 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 1736 "Ancho" => 2735 "Tamanyo" => 244711 ] ] "descripcion" => array:1 [ "en" => "Health certification model for skin and tissues. CMV, cytomegalovirus; PCR, polymerase chain reaction; VIH, human virus of immunodeficiency; VHB, hepatitis B virus; VHC, hepatitis C virus." ] ] 3 => array:7 [ "identificador" => "fig0020" "etiqueta" => "Figure 4" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr4.jpeg" "Alto" => 1358 "Ancho" => 1626 "Tamanyo" => 129412 ] ] "descripcion" => array:1 [ "en" => "Polymerase chain reaction in real time for the molecular certification of skin and tissues." ] ] 4 => array:7 [ "identificador" => "fig0025" "etiqueta" => "Figure 5" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr5.jpeg" "Alto" => 759 "Ancho" => 995 "Tamanyo" => 120376 ] ] "descripcion" => array:1 [ "en" => "Meshed human skin allograft recovered for transplant uses." ] ] 5 => array:7 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "leyenda" => "BR/C, biological recovery and cryopreservation." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Tissue type \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Preservation method \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Bone \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Gamma radiation, lyophilisation, BR/C, chemical disinfection \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Cartilage \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Gamma radiation, BR/C \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Tendon \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Gamma radiation, BR/C, chemical disinfection \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Cardiovascular tissue (arteries, veins and cardiac valves) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Chemical disinfection, BR/C \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Eye tissue (cornea, sclera) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">BR/chemical disinfection \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Skin and dermis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Gamma radiation, lyophilisation, BR/C, decellularisation and chemical disinfection \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Foetal tissues, amnions \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Gamma radiation, lyophilisation, BR/C \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Bone marrow \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Cryopreservation \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Blood and blood products \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Chemical inactivation and controlled refrigeration \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Germ cells \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Cryopreservation \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1001491.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Methods for tissue preservation for transplant uses." ] ] 6 => array:7 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "leyenda" => "VDRL, serological test for syphilis; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; HLV, human lymphotropic virus." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">General criteria for organ donation candidates \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">General criteria for tissue donation candidates \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Encephalic death certified for cadaveric donor \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Encephalic death or certification of loss of life \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Certification of loss of life \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Negative serology for: HIV 1 and 2, HBV, HCV and HLV and VDRL \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">No significant history of disease which affects the organ to be donated \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No history of major disease that affects tissues under consideration \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">No uncontrolled septic process \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Leucocytes under 15,000/dl \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">No history of extra cranial malignancy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No clinical history of autoimmune diseases \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Relative haemodynamic stability \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Consider specific exclusion criteria per tissue \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1001493.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Inclusion and exclusion criteria for organ and tissue donation." ] ] 7 => array:7 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "leyenda" => "PCR, polymerase chain reaction." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Strict control and assessment of potential donors \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Quality control of tissue surgical procurement sites \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Systematised procedure for recovery of the cellular viability of tissues based on scientific proof \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Microbiological final product certification \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Preservation of physical and chemical characteristics and biological properties of tissues \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Molecular certification of donors and tissues, based on molecular tests to reduce the waiting time periods for generation of a antigen-antibody response (PCR, PCR in real time) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Traceability of processes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Ethical criteria in donation, based on altruism and non commercialisation \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1001492.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Essential directives for the recovery of tissues." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:20 [ 0 => array:3 [ "identificador" => "bib0105" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Surgical principles in the Sutrasthanam of the Suśruta samhita management of retained foreign bodies" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "R.C. 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Banco de piel y tejidos: un modelo operativo para la recuperación y preservación de aloinjertos de piel y tejidos

Francisco Martínez-Floresa,

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fcomartinez@inr.gob.mx

Corresponding author at: Banco de Piel y Tejidos, Dirección Quirúrgica, Instituto Nacional de Rehabilitación, Secretaría de Salud, Calzada México-Xochimilco No. 289, Col.: Arenal de Guadalupe, C.P. 14389, México, D.F., Mexico. Tel.: +52 (55) 5999 1000 ext.14802.

, Hugo Sandoval-Zamoraa, Catalina Machuca-Rodriguezb, Araceli Barrera-Lópeza, Ricardo García-Cavazosc, Juan Antonio Madinaveitia-Villanuevad

a Banco de Piel y Tejidos, Instituto Nacional de Rehabilitación, Secretaría de Salud, México, D.F., Mexico

b Laboratorio de Terapia Molecular, Facultad de Estudios Superiores-Zaragoza, Universidad Nacional Autónoma de México, México, D.F., Mexico

c Escuela Superior de Medicina, Instituto Politécnico Nacional, México, D.F., Mexico

d Dirección Quirúrgica, Instituto Nacional de Rehabilitación, Secretaría de Salud, México, D.F., Mexico

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  "estado" => "S300"
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In accordance with Wright et al&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">5</span></a> Falt and Marragonni reported the first storage procedures of skin from dead bodies using solutions supplemented with 10&#37; serum as a preserving agent&#46;<a class="elsevierStyleCrossRefs" href="#bib0125"><span class="elsevierStyleSup">5&#44;6</span></a> All these steps led to the creation of a new type of establishment from the end of the 1980s&#44; equipped to store skin and other tissues&#46; These installations were latterly known by their generic name as &#8220;skin banks&#8221;&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The use of human allografts is closely related to the development of different methods for the preservation of tissues &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; These strategies are designed to integrate tissue recovery procedures which seek&#58; &#40;1&#41; cellular viability maintenance<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">7</span></a>&#59; &#40;2&#41; the preservation of proteins<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">8</span></a>&#59; &#40;3&#41; the presence of growth factors such as&#58; the epidermal growth factors&#44; the vascular endothelial growth factor&#44; the transforming growth factor beta and pro-inflammatory cytokines &#40;Il-2&#44; Il-6&#44; Il-10 TNF-&#945; alfa&#41;&#59; and &#40;4&#41; the complete integrity of tissues&#46; All these factors focus on generating biological products of high quality&#44; with top health safety and of extreme therapeutic value&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">9</span></a></p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">The procurement and preservation of tissues is a rapidly and increasingly developed activity which is positively correlated with technological and scientific advances present in biomedical sciences during the 20th century&#46; Furthermore&#44; demand for allografts for therapeutic reasons is projected to increase considerably as a result of the increase in life expectancy and its concomitant increase in chronic degenerative diseases&#46; The design of successful institutional strategies capable of promoting donation activities and tissue retrieval<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">10&#8211;12</span></a> has therefore become imperative&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The aim of our study consisted of describing the current panorama of tissue retrieval and storage with the design of a prototype institutional model authorised by the Banco de Piel y de Tejidos del Instituto Nacional de Rehabilitaci&#243;n &#40;INR&#41; for retrieval and storage of high therapeutic value&#44; thanks to the use of scientific principals applied to self sustainability of the health system needs in Mexico&#46;</p><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Worldwide regulation of skin banks</span><p id="par0030" class="elsevierStylePara elsevierViewall">Several international associations which promote protocols and directives for the technical operation of skin and tissue banks<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">13&#8211;16</span></a> were created in order to organise establishment and operations&#46; The following are of note&#58; &#40;1&#41; American Association of Tissue Banks&#44; created in 1972&#59; &#40;2&#41; Euroskin Bank &#40;Bewerjwick&#44; NL&#41; founded in 1976 and called Tissue Bank from 2010&#59; &#40;3&#41; European Association of Tissue Banks&#44; established in 1991&#59; &#40;4&#41; Asociaci&#243;n Espa&#241;ola de Bancos de Tejidos&#44; founded in 2002&#59; &#40;5&#41; Asociaci&#243;n de Bancos de Tejidos de Asia-Pac&#237;fico&#59; and &#40;6&#41; la Asociaci&#243;n Latinoamericana de Bancos de Tejidos&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">All these organisations try to regulate the standardisation of directives for the therapeutic storage and use of tissues for transplant&#44; in conjunction with other governmental&#44; ethical and scientific bodies&#46; The following central points may be highlighted from the international standards&#58; &#40;1&#41; ethical aspects regarding the procurement of tissues based on altruism and not trading&#59; &#40;2&#41; regional regulation of prevailing health laws&#59; &#40;3&#41; administrative organisation&#59; &#40;4&#41; standards for physical installations of tissue banks&#59; &#40;5&#41; recuperation of tissues with pharmaceutical quality and standards&#59; and &#40;6&#41; traceability of preservation processes&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Tissue banks in Mexico</span><p id="par0040" class="elsevierStylePara elsevierViewall">In the Mexican Republic initial activities related to tissue storage were made with bone material&#46; Pioneering procedures took place in the Hospital Central Militar and the Hospital Infantil de M&#233;xico in 1944&#46; During the 1950s similar activities were initiated in Hospital Rub&#233;n Le&#241;ero and in Hospital Regional de Monterrey&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">In 1997 the Hospital Central de Petr&#243;leos Mexicanos and the Universidad Nacional Aut&#243;noma de M&#233;xico carried out several procedures relating to tissue storage&#44; 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is a structure located within the Sistema Nacional de Salud&#44; consisting of all the establishments and hospitals possessing a licence to carry out organ or tissue donor transplant activities and cell or tissue bank activities authorised by COFEPRIS&#46; All these bodies are subject to the regulations established by law and specifically that laid down in Title XIV of Ley General de Salud&#44; in the legal regulations issued on these matters and other directives&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">13</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">In compliance with prevailing legislation&#44; the Skin and Tissue Bank of the Instituto Nacional de Rehabilitaci&#243;n is authorised to offer organs&#44; tissues and cells for transplant&#44; through organ&#44; tissue extraction&#44; skin and muculoskeletal tissue transplant&#44; and also a tissue bank &#40;skin and musculoskeletal tissue&#41;&#46; The legal context enables the Skin and Tissue Bank to have an innovative and far-reaching approach in its procedures model for procurement&#44; preservation and transplant of tissues for therapeutic purposes&#46; This approach includes social aspects for the promotion of an organ and tissue donor culture and the training of highly specialised human resources in donor and tissue preservation matters&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">The transplant Committee as a regulating body of Mexican bank activities</span><p id="par0070" class="elsevierStylePara elsevierViewall">The corner stone of the SNT are the Internal Transplant Committees in each hospital&#46; In compliance with article 316 of the Ley General de Salud&#44; these collegiate bodies comprise a health care director and a group of health professionals who are experts in this sector&#44; coordinators in donation and transplant&#44; and the necessary administrative support staff for these procedures&#46;<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">13&#44;17</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">Although in the strict sense of the word&#44; the main function of a bank is to safeguard tissues until use&#44; this activity should be secondary to the development of preservation activities with traceability of transparency and safety for operators and users&#46; The supervision of these activities was entrusted to the Comisi&#243;n Federal para la Protecci&#243;n contra Riesgos Sanitarios &#40;COFEPRIS&#41;&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Problems with skin and tissues banks in Mexico</span><p id="par0080" class="elsevierStylePara elsevierViewall">Due to the existing lag in adopting this type of establishment the following problems arise in Mexico&#58; &#40;1&#41; there is little experience in the practise of tissue storage&#59; &#40;2&#41; a high learning curve exists and high costs associated with specific training in this area&#59; &#40;3&#41; there is no active training and educational programme for the culture of organ and tissue donation&#59; &#40;4&#41; no integrated model of donation&#44; procurement and cadaveric skin processing exists within the Sistema Nacional de Salud&#59; &#40;5&#41; there is very little financial investment in scientific research aimed at tissue storage&#59; &#40;6&#41; there are problems derived from current legislation and classification of biological tissues as &#8220;supplies&#8221; in the Ley General de Salud&#59; &#40;7&#41; private companies are competing for tissue donation&#59; &#40;8&#41; the health sector lacks any industrial development for the generation of supplies&#59; &#40;9&#41; ethical problems arise derived from private banks competing for donors&#44; through practices which lack sufficient regulation&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">The Skin and Tissue Bank of the Instituto Nacional de Rehabilitaci&#243;n as a prototype model for the recuperation of tissues</span><p id="par0085" class="elsevierStylePara elsevierViewall">Since March 2009&#44; the Skin and Tissue Bank of the Instituto Nacional de Rehabilitaci&#243;n has been the Ministry of Health&#39;s leading tissue bank in tissue storage&#44; within the framework of National Health Institutes&#46; Its mission is to be a centre of excellence in the procurement&#44; processing and storage of skin and other tissues&#44; through the development of a model based on scientific research&#44; the use of new biomedical and molecular state-of-the-art technologies and the education and training of highly specialised human resources&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">In addition&#44; the bank provides specialised surgical assistance for the obtention of tissues in procurement hospitals or those generating procurement&#44; as well as their use in allogenic tissue implantation programmes&#46; At the same time it develops donor culture awareness and outreach campaigns&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">The bank reiterates the directives and principles established by the Centro Nacional de Trasplantes with the introduction of 5 essential ethical principles&#58; voluntary donation&#44; altruism&#44; solidarity&#44; confidentiality and information&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Standards of the Skin and Tissue Bank for the harvesting of skin and tissue allografts for use in transplants</span><p id="par0100" class="elsevierStylePara elsevierViewall">The model followed by the Skin and Tissue Bank of the and Instituto Nacional de Rehabilitaci&#243;n is based on complete integration of the phases involved in the tissue donation and transplant system&#44; with traceability outlined for the procedures in line with ISO-9000-2008 &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41; regulation&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Harvesting</span><p id="par0105" class="elsevierStylePara elsevierViewall">The procedure for obtaining skin and tissues is made through inter-institutional collaboration with different transplant programmes which meet the criteria established for organ and tissue donation &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46; Tissue harvesting is currently defined as a surgical event &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41; and as such quality standards for skin recovery surgery must therefore be adhered to&#46;<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">18</span></a></p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">Once informed consent has been obtained from the multiple organ donor&#39;s family and cardiac arrest meets with inclusion criteria &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#44; in the specific case of skin surface area disinfection processes are carried out based on iodine and alcohol solutions in different concentrations &#40;70&#8211;100&#37;&#41;&#44; in a surgical area with an aseptic technique&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Recovery and preservation</span><p id="par0115" class="elsevierStylePara elsevierViewall">The concept of recovery focuses on reversing or as much slowing down as possible of cell death&#44; induced by tissue hypoxy and the depletion of nutrients&#44; after the last heartbeat&#46; To do this the tissues are stored in solutions formulated with a physiological pH &#40;7&#46;4&#41; and with buffering agents in the presence of essential nutrients and antibiotics to begin the process of microbial decontamination&#46; Medium term preservation is achieved using cryopreserving solutions and pH stabilisers which enable the tissue to be maintained at a temperature below &#8722;80<span class="elsevierStyleHsp" style=""></span>&#176;C&#46; The formulation of these materials is carried out in the preparation laboratory of the tissue and skin bank itself&#44; in keeping with the good manufacturing practice and good laboratory practice&#44; and are sterilised by filtration&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Microbiological quality certification</span><p id="par0120" class="elsevierStylePara elsevierViewall">The biological quality of the tissues and the microbiological certification are essential standards for tissue preservation&#46; The standard for aerobic&#44; anaerobic and fungal microorganisms identification is to take readings at 7&#44; 14 and 21 days under specific mediums&#46;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">19</span></a> The microbiological control system is used in tissue quality control protocols&#44; with the use of solution to maintain contact with the recuperation and preservation process &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Molecular biology techniques for identification of pathogen agent identification</span><p id="par0125" class="elsevierStylePara elsevierViewall">The gold standard in identifying pathogens is carried out with the identification of genomic segments using the polymerase chain reaction technique &#40;PCR&#41;&#46; This technique which was described by Kubista Mullis and his team<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">20</span></a> has a sensitivity rate of 1<span class="elsevierStyleHsp" style=""></span>&#215;<span class="elsevierStyleHsp" style=""></span>10<span class="elsevierStyleSup">&#8722;7</span>&#59; i&#46;e&#46; it is able to identify an infected cell for every 1<span class="elsevierStyleHsp" style=""></span>&#215;<span class="elsevierStyleHsp" style=""></span>10<span class="elsevierStyleSup">7</span> healthy cells&#46; In the case of certification protocols&#44; the tests which the banks perform are made in real time&#44; searching for the human immunodeficiency virus types 1 and 2&#44; hepatitis B and C&#59; cytomegalovirus and <span class="elsevierStyleItalic">Treponema pallidum</span>&#46; Given that the technique is highly specific and sensitive&#44; tests are made in triplicate in a sterilised area and safety cabinet with laminar flow type II-AB&#46; These tests are validated for diagnostic and clinical use in humans and include internal controls &#40;calibrated as negative and positive&#41; for each test with a search in donor blood and tissue &#40;<a class="elsevierStyleCrossRef" href="#fig0020">Fig&#46; 4</a>&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">6&#44;20</span></a></p><elsevierMultimedia ident="fig0020"></elsevierMultimedia></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Physical infrastructure</span><p id="par0130" class="elsevierStylePara elsevierViewall">At present the bank consists of 5 laboratories&#44; which meet with class 100 regulations and operate according to good manufacturing practice and good laboratory practice&#46; Since this is a national reference centre&#44; the bank used its physical infrastructure meeting with directives from the Federaci&#243;n Espa&#241;ola de Bancos de Tejidos and the Asociaci&#243;n Europea de Bancos de Tejidos&#46; It is physically structured according to 3 main areas<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">10</span></a>&#58; &#40;1&#41; class 100 inner chamber&#59; &#40;2&#41; administrative area&#59; and &#40;3&#41; support and research areas&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Class 100 inner chamber structure</span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Laboratory for the preparation of materials</span><p id="par0135" class="elsevierStylePara elsevierViewall">Equipment and materials for the preparation of cleansing&#44; decontamination and maintenance solutions at constant temperature &#40;18<span class="elsevierStyleHsp" style=""></span>&#176;C&#41;&#44; filtered air &#40;class 100&#41; and positive pressure&#46;</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Quarantine laboratory</span><p id="par0140" class="elsevierStylePara elsevierViewall">Clean room with constant temperature &#40;18<span class="elsevierStyleHsp" style=""></span>&#176;C&#41;&#44; filtered air &#40;class 100&#41; and positive pressure for recovery and decontamination of tissues&#46; Refrigerators for maintaining a constant temperature &#40;4<span class="elsevierStyleHsp" style=""></span>&#176;C&#41; in decontamination processes&#46; Class IIAB biological safety cabinet for handling tissue&#46;</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Processing laboratory for musculoskeletal tissue</span><p id="par0145" class="elsevierStylePara elsevierViewall">Double-chamber clean room insulated with a constant temperature&#44; filtered air &#40;class 100&#41; and positive pressure aimed at the recovery&#44; cutting and decontamination of musculoskeletal tissue&#46;</p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Packaging laboratory</span><p id="par0150" class="elsevierStylePara elsevierViewall">Clean room with constant temperature &#40;18<span class="elsevierStyleHsp" style=""></span>&#176;C&#41;&#44; filtered air &#40;class 100&#41; and positive pressure&#44; for final tissue packaging prior to being sent for final freezing&#46; The processes are carried out in a class IIA-B biological safety cabinet for tissue handing&#46; The inner chamber connects with an area for tissue storage and safekeeping&#46;</p></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Tissue storage and safekeeping area &#40;deep freezing&#41;</span><p id="par0155" class="elsevierStylePara elsevierViewall">Restricted access area for tissue storage with temperature support systems&#44; monitoring system in real time for temperature recording and a televised surveillance system&#46; Constant temperature &#40;18<span class="elsevierStyleHsp" style=""></span>&#176;C&#41; and class 100 filtered air&#46;</p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Equipment and Sterilisation Centre &#40;CEYE&#41;</span><p id="par0160" class="elsevierStylePara elsevierViewall">Equipment and supplies for validating sterilisation processes of materials and equipment used in procurement processes&#46;</p></span><span id="sec0105" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Administrative area</span><p id="par0165" class="elsevierStylePara elsevierViewall">Designed outside central facilities and with restricted access&#46;</p></span><span id="sec0110" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Support and research areas</span><p id="par0170" class="elsevierStylePara elsevierViewall">Constituted by a laboratory of multiple uses and with a culture chamber&#44; for the development of research protocols relating to the formulation of materials&#44; cellular death blockage mechanisms and cryobiotic molecular strategies for the purpose of transplants&#46;</p></span></span></span><span id="sec0115" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Discussion and perspectives</span><p id="par0175" class="elsevierStylePara elsevierViewall">In keeping with the worldwide trend to recuperate tissues for therapeutic uses&#44; the storage of skin and other tissues in the context of healthcare needs and current Mexican medical research several of the following points must be precisely defined to obtain a better therapeutic outcome&#58;</p><span id="sec0120" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Conceptualise the procurement and harvesting of tissues as a surgical event</span><p id="par0180" class="elsevierStylePara elsevierViewall">This point necessitates a change in the conceptualisation of the obtainment of tissues as a surgical event&#44; with particular emphasis on quality&#44; as recently described in detail in the lasts amendment to the Ley General de Salud&#44; relating to the regulation governing organs and tissues &#40;12th December 2011&#41;&#46;</p></span><span id="sec0125" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Defining the type of procedure used in preservation</span><p id="par0185" class="elsevierStylePara elsevierViewall">Each method &#40;chemical decontamination&#44; lyophilisation&#44; gamma sterilisation&#41; has a different effect on the biological&#44; physical and chemical characteristics of the tissue &#40;cellular viability index&#44; loss of water&#44; of elasticity and resistance&#41;&#44; and finally&#44; in its posterior usage&#46; In our model the preliminary data indicate that the biological recuperation of tissues represents the method with the best therapeutic outcome&#44; following a long period of freezing at temperatures below 80<span class="elsevierStyleHsp" style=""></span>&#176;C below zero &#40;<a class="elsevierStyleCrossRef" href="#fig0025">Fig&#46; 5</a>&#41;&#46;</p><elsevierMultimedia ident="fig0025"></elsevierMultimedia></span><span id="sec0130" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Traceability of processes</span><p id="par0190" class="elsevierStylePara elsevierViewall">Documentation of each phase of procurement&#44; preservation and liberation of tissue&#44; respecting privacy and confidentiality data&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">The traceability of processes must document the critical route of each process and include essential documents such as&#58; &#40;1&#41; manual for specific procurement procedure&#59; &#40;2&#41; manual for specific procedure for recuperation and preservation of tissues&#59; &#40;3&#41; manual for microbiological control and specific tissue quality&#59; &#40;4&#41; procurement protocol for tissue procuring hospitals&#59; &#40;5&#41; clinical files and service formats &#40;microbiological&#44; molecular laboratory&#44; pathology&#44; etc&#46;&#41;&#59; &#40;6&#41; manual and records of preventative maintenance of equipment and installations&#59; &#40;7&#41; registry and control of access for general services and microbiological records of environmental controls&#59; and &#40;8&#41; registry and report of activities sent to the Centro Nacional de Trasplantes&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">In addition&#44; the following lines of action may have a serious impact on the growth of tissue bank activity&#58;</p></span><span id="sec0135" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Integration and growth of a hospital network for increasing regional tissue affluence</span><p id="par0205" class="elsevierStylePara elsevierViewall">Establishing a network for the procurement of tissues involves carrying out a large number of collaboration agreements in tissue procurement matters&#44; for transplant in other hospital institutions&#44; for the purpose of increasing the identification of potential tissue donors&#46;</p></span><span id="sec0140" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Implementation of a research programme in tissue pharmaceutical cryobiotics with therapeutic uses</span><p id="par0210" class="elsevierStylePara elsevierViewall">The aim of this is to promote the design of procurement and cryopreservation protocols for skin and tissues&#44; and also to foster the broadening of scientific research to reduce dependency on imported materials and promote self-sustainability of operations&#44; focused on&#58; &#40;1&#41; scientific procedures for preservation and tissue cryobiology aimed at obtaining high quality biological and therapeutically effective products&#59; &#40;2&#41; generation of materials and patents for the bank&#39;s self sustainability&#59; and &#40;3&#41; scientific dissemination of processes used in other institutions&#46;</p></span><span id="sec0145" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0165">Implementation of an academic surgical training programme for tissue procurators</span><p id="par0215" class="elsevierStylePara elsevierViewall">Arranging the registration and execution of multi-tissue procurator courses&#44; endorsed by both academic institutions and the Centro Nacional de Trasplantes In Mexico to form specialised and highly trained personnel&#46; Furthermore&#44; to include specific modules on the surgical procedures involved in tissue procurement and transplant in pre-grade modules study programmes&#46;</p></span><span id="sec0150" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0170">Advocacy of a more widespread cadaveric skin donation culture</span><p id="par0220" class="elsevierStylePara elsevierViewall">Driving the training programme for leaders who will be the promoters of the culture of organ and tissue donation in collaboration with non-governmental organisations and mass media communication campaigns&#44; with use of social networks and internet&#46;</p><p id="par0225" class="elsevierStylePara elsevierViewall">Last but not least&#44; several ethical considerations have to be readdressed&#44; starting with the fact that the obtainment of tissues is an act of altruistic donation with no profit making or commercialisation and process recuperation quotas must therefore be regulated and defined&#59; this point is also being addressed by the World Health Organisation&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">The coordination and integration of the organ and tissue donation and transplant programmes must be carried out with functional&#44; responsible and equitable participation from areas of research&#44; human resources training and health care services&#46;</p><p id="par0235" class="elsevierStylePara elsevierViewall">This model is merely one of the medium term proposals to modify the current tissue recovery setting&#46; Possibly in a couple of decades&#44; similarly to the Spanish model it could become the world leader of organ and tissue donor programmes&#46;</p></span></span><span id="sec0155" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0175">Financing</span><p id="par0240" class="elsevierStylePara elsevierViewall">This study was financed by the <span class="elsevierStyleGrantSponsor" id="gs1">Council for Science and Technology</span> through the Fondos Sectoriales de Investigaci&#243;n in Salud CONACYT-FOSIS 2011-1-161624&#46;</p></span><span id="sec0160" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0180">Conflict of interests</span><p id="par0245" class="elsevierStylePara elsevierViewall">The authors have no conflict of interests to declare&#46;</p></span></span>"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Tissue storage is a medical process that is in the regulation and homogenisation phase in the scientific world&#46;</p><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The international standards require the need to ensure safety and efficacy of human allografts such as skin and other tissues&#46; The activities of skin and tissues banks currently involve their recovery&#44; processing&#44; storage and distribution&#44; which are positively correlated with technological and scientific advances present in current biomedical sciences&#46;</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">A description is presented of the operational model of Skin and Tissue Bank at Instituto Nacional de Rehabilitaci&#243;n as successful case for procurement&#44; recovery and preservation of skin and tissues for therapeutic uses&#44; with high safety and biological quality&#46; The essential and standard guidelines are presented as keystones for a tissue recovery programme based on scientific evidence&#44; and within an ethical and legal framework&#44; as well as to propose a model for complete overview of the donation of tissues and organ programmes in Mexico&#46; Finally&#44; it concludes with essential proposals for improving the efficacy of transplantation of organs and tissue programmes&#46;</p></span>"
      ]
      "es" => array:2 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">El almacenamiento de tejido es un proceso m&#233;dico en fase de regulaci&#243;n y homogenizaci&#243;n cient&#237;fica en el mundo&#46; Los est&#225;ndares internacionales exigen garantizar la seguridad y la eficacia de los aloinjertos humanos como piel y otros tejidos&#46; En la actualidad las actividades de los bancos de piel y tejidos involucran la recuperaci&#243;n&#44; procesamiento&#44; almacenamiento y distribuci&#243;n como proceso de desarrollo&#44; que se correlaciona positivamente con los avances tecnol&#243;gicos y cient&#237;ficos presentes en las ciencias biom&#233;dicas actuales&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Se describe el modelo instaurado por el Banco de Piel y de Tejidos del Instituto Nacional de Rehabilitaci&#243;n como un caso exitoso para la procuraci&#243;n&#44; recuperaci&#243;n y preservaci&#243;n de piel con fines terap&#233;uticos&#44; alta seguridad sanitaria y elevada calidad biol&#243;gica&#46; Se discuten los fundamentos y est&#225;ndares empleados en el programa actual de recuperaci&#243;n de tejidos con base en la evidencia cient&#237;fica disponible&#44; el contexto &#233;tico y el marco jur&#237;dico vigente de la donaci&#243;n de tejidos en M&#233;xico&#46; Se concluye con algunas propuestas para mejorar la eficacia de los programas de trasplantes&#46;</p></span>"
      ]
    ]
    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Francisco Mart&#237;nez-Flores F&#44; Sandoval-Zamora H&#44; Machuca-Rodriguez C&#44; Barrera-L&#243;pez A&#44; Garc&#237;a-Cavazos R&#44; Madinaveitia-Villanueva JA&#46; Banco de piel y tejidos&#58; un modelo operativo para la recuperaci&#243;n y preservaci&#243;n de aloinjertos de piel y tejidos&#46; Cir Cir&#46; 2016&#59;84&#58;85&#8211;92&#46;</p>"
      ]
    ]
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          "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Operational model of the Skin and Tissue Bank of the Instituto Nacional de Rehabilitaci&#243;n&#46; H&#44; hospital&#59; INNyN&#44; Instituto Nacional de Neurolog&#237;a y Neurocirug&#237;a&#59; MVS&#44; Manuel Velasco Suarez&#46;</p>"
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          "en" => "<p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Surgical procurement of skin&#46;</p>"
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        "tipo" => "MULTIMEDIAFIGURA"
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          "en" => "<p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Health certification model for skin and tissues&#46; CMV&#44; cytomegalovirus&#59; PCR&#44; polymerase chain reaction&#59; VIH&#44; human virus of immunodeficiency&#59; VHB&#44; hepatitis B virus&#59; VHC&#44; hepatitis C virus&#46;</p>"
        ]
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          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Polymerase chain reaction in real time for the molecular certification of skin and tissues&#46;</p>"
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          "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Meshed human skin allograft recovered for transplant uses&#46;</p>"
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        "tabla" => array:2 [
          "leyenda" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">BR&#47;C&#44; biological recovery and cryopreservation&#46;</p>"
          "tablatextoimagen" => array:1 [
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                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Tissue type&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Preservation method&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Bone&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Gamma radiation&#44; lyophilisation&#44; BR&#47;C&#44; chemical disinfection&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Cartilage&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Gamma radiation&#44; BR&#47;C&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Tendon&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Gamma radiation&#44; BR&#47;C&#44; chemical disinfection&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Cardiovascular tissue &#40;arteries&#44; veins and cardiac valves&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Chemical disinfection&#44; BR&#47;C&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Eye tissue &#40;cornea&#44; sclera&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">BR&#47;chemical disinfection&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Skin and dermis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Gamma radiation&#44; lyophilisation&#44; BR&#47;C&#44; decellularisation and chemical disinfection&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Foetal tissues&#44; amnions&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Gamma radiation&#44; lyophilisation&#44; BR&#47;C&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Bone marrow&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Cryopreservation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Blood and blood products&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Chemical inactivation and controlled refrigeration&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Germ cells&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Cryopreservation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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          "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Methods for tissue preservation for transplant uses&#46;</p>"
        ]
      ]
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        "etiqueta" => "Table 2"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "tabla" => array:2 [
          "leyenda" => "<p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">VDRL&#44; serological test for syphilis&#59; HBV&#44; hepatitis B virus&#59; HCV&#44; hepatitis C virus&#59; HIV&#44; human immunodeficiency virus&#59; HLV&#44; human lymphotropic virus&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">General criteria for organ donation candidates&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">General criteria for tissue donation candidates&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Encephalic death certified for cadaveric donor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Encephalic death or certification of loss of life&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Certification of loss of life&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Negative serology for&#58; HIV 1 and 2&#44; HBV&#44; HCV and HLV and VDRL&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">No significant history of disease which affects the organ to be donated&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">No history of major disease that affects tissues under consideration&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">No uncontrolled septic process&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Leucocytes under 15&#44;000&#47;dl&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">No history of extra cranial malignancy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">No clinical history of autoimmune diseases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Relative haemodynamic stability&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Consider specific exclusion criteria per tissue&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
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        "descripcion" => array:1 [
          "en" => "<p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Inclusion and exclusion criteria for organ and tissue donation&#46;</p>"
        ]
      ]
      7 => array:7 [
        "identificador" => "tbl0015"
        "etiqueta" => "Table 3"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "tabla" => array:2 [
          "leyenda" => "<p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">PCR&#44; polymerase chain reaction&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Strict control and assessment of potential donors&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Quality control of tissue surgical procurement sites&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Systematised procedure for recovery of the cellular viability of tissues based on scientific proof&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Microbiological final product certification&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Preservation of physical and chemical characteristics and biological properties of tissues&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Molecular certification of donors and tissues&#44; based on molecular tests to reduce the waiting time periods for generation of a antigen-antibody response &#40;PCR&#44; PCR in real time&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Traceability of processes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Ethical criteria in donation&#44; based on altruism and non commercialisation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
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        "descripcion" => array:1 [
          "en" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">Essential directives for the recovery of tissues&#46;</p>"
        ]
      ]
    ]
    "bibliografia" => array:2 [
      "titulo" => "References"
      "seccion" => array:1 [
        0 => array:2 [
          "identificador" => "bibs0005"
          "bibliografiaReferencia" => array:20 [
            0 => array:3 [
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              "referencia" => array:1 [
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                            0 => "R&#46;C&#46; Chakrovorty"
                          ]
                        ]
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                  ]
                  "host" => array:1 [
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                  "host" => array:1 [
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            3 => array:3 [
              "identificador" => "bib0120"
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              "referencia" => array:1 [
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                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Refrigerated skin grafts"
                      "autores" => array:1 [
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            4 => array:3 [
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Article information

ISSN: 24440507
Original language: English

DOI:10.1016/j.circen.2015.12.008

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Year/Month	Html	Pdf	Total

2024 November	12	3	15
2024 October	46	7	53
2024 September	43	10	53
2024 August	38	5	43
2024 July	37	5	42
2024 June	67	5	72
2024 May	49	2	51
2024 April	62	5	67
2024 March	70	136	206
2024 February	85	3	88
2024 January	117	7	124
2023 December	109	12	121
2023 November	118	8	126
2023 October	115	15	130
2023 September	61	13	74
2023 August	65	13	78
2023 July	83	8	91
2023 June	72	8	80
2023 May	92	10	102
2023 April	106	16	122
2023 March	149	7	156
2023 February	82	6	88
2023 January	91	7	98
2022 December	113	18	131
2022 November	85	23	108
2022 October	90	22	112
2022 September	103	14	117
2022 August	104	9	113
2022 July	64	13	77
2022 June	53	9	62
2022 May	58	18	76
2022 April	52	11	63
2022 March	64	6	70
2022 February	81	4	85
2022 January	155	10	165
2021 December	78	15	93
2021 November	95	22	117
2021 October	90	33	123
2021 September	55	13	68
2021 August	65	14	79
2021 July	28	19	47
2021 June	45	17	62
2021 May	40	16	56
2021 April	65	31	96
2021 March	79	42	121
2021 February	43	12	55
2021 January	42	28	70
2020 December	39	13	52
2020 November	44	18	62
2020 October	38	7	45
2020 September	24	8	32
2020 August	42	7	49
2020 July	23	12	35
2020 June	49	13	62
2020 May	28	11	39
2020 April	33	6	39
2020 March	29	11	40
2020 February	26	13	39
2020 January	19	8	27
2019 December	43	13	56
2019 November	23	3	26
2019 October	29	2	31
2019 September	43	3	46
2019 August	35	2	37
2019 July	57	13	70
2019 June	99	18	117
2019 May	154	57	211
2019 April	48	21	69
2019 March	18	7	25
2019 February	29	6	35
2019 January	12	4	16
2018 December	13	2	15
2018 November	15	4	19
2018 October	23	0	23
2018 September	22	5	27
2018 August	10	4	14
2018 July	12	3	15
2018 June	11	1	12
2018 May	6	2	8
2018 April	12	1	13
2018 March	13	3	16
2018 February	14	0	14
2018 January	7	1	8
2017 December	13	0	13
2017 November	15	2	17
2017 October	14	2	16
2017 September	16	6	22
2017 August	10	4	14
2017 July	10	3	13
2017 June	22	3	25
2017 May	33	4	37
2017 April	27	4	31
2017 March	15	18	33
2017 February	24	3	27
2017 January	23	2	25
2016 December	33	6	39
2016 November	31	3	34
2016 October	37	5	42
2016 September	62	9	71
2016 August	38	3	41
2016 July	26	6	32
2016 June	37	10	47
2016 May	36	20	56
2016 April	47	17	64
2016 March	62	23	85

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