A toolkit for a modern gynecologic oncology tissue bank.

OBJECTIVES: Tissue banking procedures have evolved to keep pace with precision medicine, technology, emerging understanding of racial disparities, and regulatory requirements. However, there is little published guidance regarding strategies to create and maintain a successful biorepository. Our objective is to describe the infrastructure and protocols used by our Gynecologic Oncology Tissue Bank. METHODS: Our Tissue Bank was founded in 1992. In August 2022, internal funding was used to modernize the Tissue Bank. We hired three full-time employees, implemented universal screening of patients treated by gynecologic oncology faculty, updated consenting protocols, and standardized communication with providers. Tumor tissue, blood derivatives, ascites, and pleural fluid were collected from eligible, consenting patients and processed. Patient-derived cell lines and organoids were generated. For quality control purposes, one formalin-fixed, paraffin-embedded (FFPE) sample per tissue site was analyzed by a board-certified pathologist. All samples were labeled and tracked in an OpenSpecimen collection protocol and clinically annotated in a secure database. RESULTS: From August 2022 to October 2023, 227 patients (83% white, 15% Black, 1% Asian) were enrolled and 4249 specimens were collected. Adherent cell lines were generated from 15 patients with ovarian cancer and cell suspensions for organoid generation were collected from 46 patients with ovarian cancer. A recharge center was established to self-sustain the Tissue Bank. Samples have been shared with academic and commercial collaborators. CONCLUSIONS: Our Tissue Bank has enrolled a large number of diverse patients, collected numerous specimen types, and collaborated widely. The procedures described here provide guidance for other institutions establishing similar resources.

Influence of donor characteristics on the milk donation volume and microbiological quality of donated human milk in first 3 years of work of the Croatian human milk bank-retrospective observational study.

OBJECTIVES: Donated human milk is the best possible alternative when mother's own milk is not available. The aim of this study is to investigate whether there are differences in the milk donation volumes and microbiological quality of donated milk depending on human milk donors (HMDs) characteristics. METHODS: We analyzed data on the HMDs who donated milk in the first three years of work of human milk bank (HMB) - November 2019 to January 2023. The data on the volume of donated milk in L and suitable microbiological quality assessed by the number and isolated species of bacteria were collected from questionnaires filled out by HMDs and documentation administered by HMB employees and are presented using descriptive and comparative statistics. RESULTS: Two hundred HMDs were included in this study. The majority of them are between 26 and 35 years of age, reside in capital city or the surrounding county, have given birth to a full-term child vaginally, and express surplus milk through a breast pump. Donor mothers of preterm born infants (14.5 %) donated greater quantities, there is statistically significant difference in the median of volume of milk donated (9.6 vs. 6.4, p=0.026). Milk expressed manually shows better results in microbiological quality (median percentage 100 vs. 82 vs. 100, p=0.040), while by comparing other characteristics of the donors, no difference was found between the groups. CONCLUSIONS: It is important to be aware of the characteristics of previous HMDs in order to direct the HMB future promotional and educational activities.

Biological parameters for quality evaluation of allografts from the Brazilian National Institute of Traumatology and Orthopedics tissue bank.

Bone allografts are clinically used in a variety of surgical procedures, and tissue banks are responsible for harvesting, processing, quality testing, storing, and delivering these materials for transplantation. In tissue banks, the bone is processed for the removal of all organic content, remaining only the tissue structure (scaffold). However, several studies have shown that even after using different processing methods, viable cells, functional proteins, and DNA may still persist in the tissue, which constitute the main causes of graft rejection. Therefore, the objective of this study was to establish techniques and biological parameters for quality validation of allografts. To this end, we propose the use of 3 combined methods such as microscopy, histology, and molecular biology techniques to evaluate the quality of allografts harvested and processed by the Brazilian National Institute of Traumatology and Orthopedics (INTO) tissue bank according to the donation criteria of the Brazilian National Health Surveillance Agency and the Brazilian National Transplant System. Bone fragments from different processing stages showed no viable cells on histology, an intact extracellular matrix on scanning electron microscopy, and gradual reduction in DNA amount. Different techniques were used to demonstrate the quality of allografts produced by the INTO tissue bank and to establish biological parameters for ensuring the safety and quality of these products. Future studies need to be undertaken to assess and validate the efficacy of the decellularization process in larger bone grafts with diverse architectural configurations.

Development and validation of cryopreserved or freeze-dried decellularized human dermis for transplantation.

For decades, dermal tissue grafts have been used in various regenerative, reconstructive, and augmentative procedures across the body. To eliminate antigenicity and immunogenic response while still preserving the individual components and collective structural integrity of the extracellular matrix (ECM), dermis can be decellularized. Acellular dermal matrix (ADM) products like such are produced to accurately serve diverse clinical purposes. The aim of the present study is to evaluate the efficacy of a novel decellularization protocol of the human dermis, which eliminates residual human genetic material without compromising the biomechanical integrity and collagenous content of the tissue. Moreover, a freeze-drying protocol was validated. The results showed that though our decellularization protocol, human dermis can be decellularized obtaining a biocompatible matrix. The procedure is completely realized in GMP aseptic condition, avoiding tissue terminal sterilization.

A management model in blood, tissue and cell establishments to ensure rapid and sustainable patient access to advanced therapy medicinal products in Europe.

Blood, tissue and cell establishments (BTCs) stand out in the management of donor selection, procurement and processing of all types of substances of human origin (SoHO). In the last decades, the framework created around BTCs, including hospitals and national health system networks, and their links to research, development and innovation organizations and agencies have spurred their involvement in the study of groundbreaking advanced therapy medicinal products (ATMP). To further improve strategic synergies in the development of ATMPs, it will be required to promote intra- and inter-European collaborations by creating an international network involving BTCs and major stakeholders (i.e., research organizations, hospitals, universities, patient associations, public agencies). This vision is already shared with the European Blood Alliance, the association of non-profit blood establishments, with 26 member states throughout the European Union and European Free Trade Association states. Herein we present and analyze the "BTC for ATMP Development And Manufacture" (BADAM) model, an ethically responsible business model based on the values and missions of BTCs and their commitment to health equity, patient access and education (based on voluntary donation of SoHO to address unmet clinical needs, while contributing to training professionals and scientific literacy of our Society).

Decellularized cryopreserved human pericardium: a validation study towards tissue bank practice.

Pericardial patches are currently used as reconstructive material in cardiac surgery for surgical treatment of cardiac septal defects. Autologous pericardial patches, either treated with glutaraldehyde or not, can be used as an alternative to synthetic materials or xenograft in congenital septal defects repair. The availability of an allogenic decellularized pericardium could reduce complication during and after surgery and could be a valid alternative. Decellularization of allogenic tissues aims at reducing the immunogenic reaction that might trigger inflammation and tissue calcification over time. The ideal graft for congenital heart disease repair should be biocompatible, mechanically resistant, non-immunogenic, and should have the ability to growth with the patients. The aim of the present study is the evaluation of the efficacy of a new decellularization protocol of homologous pericardium, even after cryopreservation. The technique has proven to be suitable as a tissue bank procedure and highly successful in the removal of cells and nucleic acids content, but also in the preservation of collagen and biomechanical properties of the human pericardium.

Allogenic bone grafts and postoperative surgical site infection: are positive intraoperative swab cultures predictive for a higher infectious risk?

In spine surgery, allogenic bone grafts are often required to ensure bone fusion, however, the main concern regarding their use is the infection risk: therefore, an intraoperative swab for culture test is performed. The cost-effectiveness of these swabs and their influence on the patients' postoperative course have often been questioned. This study aims at determining whether positive spine allograft culture results are predictive of an increased risk of surgical site infection and whether they influence the surgeon's choices in postoperative management. The records of 340 patients who received allogenic bone graft during spinal fusion surgery in our institution were reviewed, for a total of 677 allografts. Each graft was swabbed intraoperatively. All patients were followed clinically for postoperative complications. Infection was diagnosed based on clinical data, blood tests and radiographic images, all assessed by an infectious disease specialist. Only 4 of the 677 allografts used (0.6%) resulted positive at the intraoperative swab culture. Three cultures were positive for Staphylococcus epidermidis and one culture for S. warneri. No clinical infection occurred in any of these patients. Twenty-eight of the 340 patients (8.2%) developed an infection, but none of them had a positive intraoperative swab culture. The most common microbiologic pathogen isolated from this cohort was S. aureus. According to our series, intraoperative swab culture results were not predictive for higher risk of infection and did not affect the clinical behavior of the surgeons in postoperative management.

Ten-year experience with cryopreserved vascular allografts in the Croatian Cardiovascular Tissue Bank.

The Croatian Cardiovascular Tissue Bank (CTB) was established in June 2011. Activities managed by CTB are processing of heart valves and blood vessels, as well as quality control, storage, medical release and distribution of allografts. The aim of this report is to present CTB's vascular tissue activities and retrospectively evaluate the outcomes of their use in the University Hospital Centre Zagreb. Between June 2011 and July 2021, 90 vascular allografts (VAs) from 55 donors after brain death were referred to CTB. Only 54% of VAs met the tissue quality requirements while 46% of tissues were discarded. The most frequent reasons for discard were unacceptable morphology and initial microbiological contamination. Altogether 42 VAs were released for transplantation and 37 of them were used in 27 surgical procedures. The most common indication for surgery was prosthetic graft or stent infection. According to the anatomic position of vascular reconstruction, patients were divided in the aortic and peripheral reconstruction group. A total of 23 patients were treated. In the aortic reconstruction group 58% of patients did not experience any graft-related complications. In the group of patients who underwent peripheral reconstruction significant incidence of reinfection was observed highlighting it as a major graft-related complication. Despite the small patient groups and limited duration of follow-up, presented clinical outcomes provide valuable information on the efficacy of vascular allografts. Additional clinical results collected on a larger patient groups and comparison to other reconstructive treatment options are necessary.

Amniotic membrane extract eye drops: a new approach to severe ocular surface pathologies.

A protocol for processing amniotic membrane as an extract to be re-hydrated and administered topically as eye drops (amniotic membrane extract eye drops, AMEED) has been developed. Safety and efficacy of AMEED was assessed in patients with severe ocular surface pathologies. prospective clinical follow-up of ocular surface symptoms before and after regular application of the AMEED for at least 4 weeks on patients with severe ocular surface disorders as chronic dry eye disease, limbal stem cell deficiency, neurotrophic ulcer and permanent and disabling symptomatology that were refractory to conventional treatment. Efficacy and tolerability were assessed based on patient-reported symptoms, objective measurements, and reports of adverse events. Thirty-six eyes from 25 patients were included. Although the visual quality function score, by means of a VQF25 questionnaire, was not statistically different after the treatment (p = 0.4657), there was a clear trend, statistically significant, towards the improvement in ocular symptoms like foreign body sensation, itching and stinging (p < 0.05) and clinical presentation of the pathology. All patients with corneal ulcer showed complete epithelization. Topically applied AMEED proved to be safe, well tolerated and effective in reducing the symptoms and clinical signs of severe ocular disease. Further studies are needed to confirm the best indications for AMEED use.

Impact of Sars-CoV-2 pandemic on the Veneto Region multitissue bank activity.

Covid pandemic affected donation activities worldwide, especially for living donation due to the lack of elective surgery. Moreover, the number of heart-beating and non-heart beating donors has recorded a decrease. Fondazione Banca dei Tessuti di Treviso (FBTV) is a non-profit healthcare organisation, located in Veneto Region, tasked with procurement, processing, preserving, validating and distributing human tissue for clinical use. During Covid-19 outbreak, operations in FBTV have never stopped and a great effort was required to maintain a standard trend of activity. The aim of this study was to describe the impact of Sars-CoV-2 on the activity of a multitissue bank in Italy. Moreover, we investigated the presence of the virus in tissues retrieved from two Sars-CoV-2 positive cadaver donors. Our survey demonstrated that the transplantation network of Veneto Region has positively reacted to the pandemic scenario, thanks to the effort of all personnel involved. Statistical analyses underlined that most of the activities of the tissue bank were unaffected during the Sars-CoV-2 pandemic.

Lyophilized amniotic membrane graft for primary pterygium surgery: preliminary results.

The aim of this study was to investigate the tolerability, safety and efficacy of new lyophilized amniotic membrane (LAM) presentation for ocular use. A prospective case-series cohort of four patients with primary nasal pterygium which undergone excision and LAM implantation was evaluated for complications and clinical outcomes. Surgical manipulation of LAM was also assessed. LAM was stiff and easy to manipulate as well as no tearing occurred during surgery or suturing. Ocular comfort was checked and similar among those patients with LAM glued or sutured. After 12 months, there were no issues about tolerability or adverse events. Lower cosmetic outcomes (recurrence) were stated in 3 patients. Our study showed that LAM could be an effective alternative to cryopreserved amniotic membrane for graft after pterygium excision surgery. Its main advantage, storage at room temperature, can make it of immediate availability. Further studies comparing clinical outcomes of pterygium surgery with cryopreserved amniotic membrane versus LAM would confirm the benefits of the last.

Algorithms for the Testing of Tissue Donors for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus.

BACKGROUND: Although transmission of pathogenic viruses through human tissue grafts is rare, it is still one of the most serious dreaded risks of transplantation. Therefore, in addition to the detailed medical and social history, a comprehensive serologic and molecular screening of the tissue donors for relevant viral markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) is necessary. In the case of reactive results in particular, clear decisions regarding follow-up testing and the criteria for tissue release must be made. METHODS: Based on the clinical relevance of the specific virus markers, the sensitivity of the serological and molecular biological methods used and the application of inactivation methods, algorithms for tissue release are suggested. RESULTS: Compliance with the preanalytical requirements and assessment of a possible hemodilution are mandatory requirements before testing the blood samples. While HIV testing follows defined algorithms, the procedures for HBV and HCV diagnostics are under discussion. Screening and decisions for HBV are often not as simple, e.g., due to cases of occult HBV infection, false-positive anti-HBc results, or early window period positive HBV NAT results. In the case of HCV diagnostics, modern therapies with direct-acting antivirals, which are often associated with successful treatment of the infection, should be included in the decision. CONCLUSION: In HBV and HCV testing, a high-sensitivity virus genome test should play a central role in diagnostics, especially in the case of equivocal serology, and it should be the basis for the decision to release the tissue. The proposed test algorithms and decisions are also based on current European recommendations and standards for safety and quality assurance in tissue and cell banking.

Comparison of Total Immunoglobulin G in Ante- and Postmortem Blood Samples from Tissue Donors.

BACKGROUND: A serology testing for infectious diseases (HIV, hepatitis B and C, syphilis) is mandatory in tissue donors. In many donors postmortem blood is the only sample available. Even though serological tests and nucleic acid amplification tests (NAT) used are validated for postmortem blood, a characterization of those blood samples is not yet established. We therefore investigated the total immunoglobulin G (IgG) content in postmortem blood of tissue donors and compared it to a corresponding antemortem blood sample. METHODS: Ante- and postmortem blood samples were obtained from 100 consecutive tissue donors. The total IgG of all samples was measured using an immune-turbidometric test on the AU 480 Chemistry Analyzer (Beckman Coulter). RESULTS: The mean total IgG concentration of antemortem blood samples from all 100 donors was 8.9 g/L ± 3.7 g/L (median 8.9 g/L, range 1.5 to 23.8 g/L). In 80 donors the IgG concentration in the antemortem blood sample was within the normal range with values ≥6 g/L (mean 10.0 g/L ± 3.3 g/L, median 9.3 g/L,). The total IgG concentration of the postmortem blood samples was lower with 7.2 g/L ± 3.2 g/L (median 6.7 g/L, range 0.6 to 18.2 g/L). The difference between the values of the antemortem and postmortem blood samples was 1.7 g/L ± 2.6 g/L (16.3%) (median 1.6 g/L, range -7.7 to 10.1 g/L). In 36 donors this difference was less than 10%, in 23 it was between 10 and 25%, in 33 between 26 and 50%, and in 8 over 50%. In 57 donors the total IgG in the postmortem blood sample was within the normal range with ≥6 g/L, in 53 of them also the value of the antemortem blood sample was within the normal range. No correlation for total IgG was found regarding the donor characteristics (age, sex, disease) and the sample characteristics (hemolysis, postmortem time). CONCLUSION: Total IgG values in antemortem samples were below the lower limit of 6 g/L in 20% of the cases. Total IgG was significantly lower in the postmortem samples compared to the antemortem samples, while 57% were still above the lower limit. No correlation with the postmortem time could be found. This lowered IgG levels should be payed attention to when using postmortem blood for infectious serology testing. Additional NAT testing should be considered.

Impact of valve fenestrations and structural changes in homografts on the long-term outcome in the recipient.

Homografts have long been used for right ventricular outflow tract (RVOT) reconstruction. Tissue banks struggle to meet the clinical demand of tissue, with insufficient donor availability and strict recommendations on tissue quality with high proportions of discards. This study analyzes the long-term outcome of patients receiving a homograft with small fenestrations of the cusps or other structural changes, to evaluate if minor impairment of the homograft affects the durability. Homograft characteristics and patient outcome were described. Follow-up was maximum 24 years. Structural changes of the homografts were analyzed in relation to patient outcome, using univariable and multivariable Cox proportional hazard regression. Between 1995 and 2018, 468 patients received 535 homografts in the RVOT in Lund. Median recipient age was 13 years. There were 137 (26.9%) reinterventions. Freedom from reintervention was 75.8% (95% CI 71.3-79.7%) at 10 years and 57.4% (95% CI 50.0-64.0%) at 20 years. Small fenestrations of the cusps, fibrosis of the cusps and minor atheromatosis of the vessel did not show any statistically significant impact on long-term outcome, hazard ratio = 0.46 (95% CI 0.11-1.87, p = 0.276) and hazard ratio = 0.80 (95% CI 0.25-2.56, p = 0.704). Minor structural changes of the homografts seem to be acceptable without affecting the long-term durability.

Amniotic membrane extract eye drops for ocular surface diseases: use and clinical outcome in real-world practice.

PURPOSE: To study the indications and clinical outcomes, in a real-word setting, of amniotic membrane extract eye drops (AMEED) use for ocular surface disease (OSD). METHODS: A retrospective study of patients treated with topical AMEED between January 2018 and January 2020 was conducted. Patients were classified in two groups according to specific OSD-dry eye disease (DED) and wound healing delay (WHD) groups. Demographics, comorbidities, treatment duration and clinical outcomes were analysed. RESULTS: A total of 50 eyes of 36 patients with or without previous treatments were included. Patients in the DED group presented more systemic comorbidities (83 vs 22%; p < 0.001) and spent more mean time under AMEED treatment (10 vs 7.2 months average) than the WHD group (p = 0.0104). In four patients, long-term treatment (more than 24 months) was reported. Global similar symptomatic improvement was reported for both groups (DED 88.9% vs WHD 100%; p = 0.486), with the WHD group especially consisting in general relief (78%) and the DED group reporting more pain improvement (44%) (p = 0.011). Regarding patients with autologous serum as a previous treatment, no statistical differences were found in subjective or objective improvement. An overall success was achieved in 94.4% of the cases and no adverse events were found. CONCLUSION: AMEED administration is a promising mean to treat OSD such as dry eye, persistent epithelial defect and corneal ulcers. Although AMEED may be effective in the treatment of severe DED and persistent epithelial defect or corneal ulcers, conclusions are limited owing to the absence of controlled clinical trials.

Innovative adaptation of the "spare tissues concept" applied for olecranon coverage of a severe burn patient: A case report.

BACKGROUND: The management of bone exposure in patients with extensive burns could be a challenge due to the lack of healthy tissue. In such cases, it could be interesting to use any still healthy tissue initially destined for amputation and use it to cover up another site. We present the case of a sever burn patient for whom we used the only healthy palmar hand skin to cover an olecranon exposure. CLINICAL CASE DESCRIPTION: A 38-year-old man has been admitted in burn victim unit with extensive deep burns on 60% of the total body surface. An exposure of the left olecranon was appeared occurring on a burned area, with absence of healthy local tissues available for coverage. Concomitantly a trans-radial amputation was indicated because of severe digits burns leading to an impossibility to preserve the function of the hand. A palmar skin area was healthy leading to harvested this palmar skin flap pedicled on ulnar vessels. Early post-operative healing was satisfactory and no vascular suffering of the flap has been observed with a total healing at three weeks. CONCLUSION: In any patient the spare tissues concept should be keep in mind when amputation is indicated simultaneously with a problematic of loss of substance coverage to a proximity area. In this case of severe burn patient, we used a palmar skin flap pedicled on the ulnar vessels to cover an olecranon exposure.

A Biobank of Stem Cells of Human Exfoliated Deciduous Teeth: Overview of Applications and Developments in Brazil.

A biobank is an organized collection of biological human material and its associated information stored for research according to regulations under institutional responsibility, without commercial purposes, being a mandatory and strategical activity for research, regenerative medicine, and innovation. Stem cells have largely been employed in research and frequently stored in biobanks, which have been used as an essential source of biological materials. Stem cells of human exfoliated deciduous teeth (SHED) are stem cells which have a high multipotency and can be easily obtained. Besides, this extremely accessible tissue has advantages with respect to storage, as the SHED obtained in childhood can be used in later life, which implies the necessity for the creation and regulation of biobanks. The proper planning for the creation of a biobank includes knowledge of the material types to be stored, requirements regarding handling and storage conditions, storage time, and room for the number of samples. Thus, this study aimed to establish an overview of the development of a SHED biobank. Ethical and legal standardization, current applications, specific orientations, and challenges for the implementation of a SHED biobank were discussed. Through this overview, we hope to encourage further studies to use SHED biobanks.

Analysis of impact on tissue activity during COVID-19 outbreak: a survey of 8 banks in Spain.

On March 19 World Health Organization declare the pandemic situation by outbreak coronavirus disease 2019 in the world. The pressure on the health care system has been very high in several countries. Spanish National Transplant Organization (ONT) have made many efforts in maintaining transplantation activity. Although the impact of the pandemic on organ activity has been analysed, to date, less data exist regarding the impact on tissue activity. The aim of this study has been the evaluation of the possible impact on the procurement, processing and distribution of tissues during the peak period of the pandemic COVID-19 in Spain. For this study, a multicentre analysis has been made with a survey of the tissue banks in Spain, during the period March 1 to April 30, 2020. Our data suggest that the impact of coronavirus in Spain has affected dramatically tissue donation but with a moderate effect on stored tissues such as bone, valves, vessels or skin. Tissue banks should prepare if future next pandemic waves surges so that tissue provision is guaranteed both in urgent and elective surgeries.

Current clinical application of sclera and amniotic membrane for ocular tissue bio-replacement.

To report the current clinical applications and trends of scleral and amniotic membrane use in ophthalmology. Review of annual reports from the Catalan Transplant Organization (OCATT), on scleral patch and amniotic membrane eye indications in Catalonia region (Spain) over a 6-year period from 2013 to 2018. A total of 874 scleral and 1665 amniotic membranes patches were implanted, from January 2013 to December 2018. The most frequent indication over the 6-year period for scleral patch was glaucoma surgery (77.5%), eyelid reconstruction (5.2%) and corneal or scleral ulcer (5%). Regarding amniotic membrane, corneal ulcer (26.9%), conjunctival reconstruction (23.8%) and corneal epithelial defect (22.7%) were the most common indications. During the study period, an increasing trend was found on sclera patches for eyelid reconstruction (p = 0.0032) and amniotic membrane for inflammation management (p = 0.0198). Glaucoma surgery and corneal ulcers have represented the top indications for scleral patch and amniotic membrane use, over the period, respectively. A significant trend has also been found towards eyelid reconstruction using scleral patches and amniotic membrane for anterior segment inflammation management. This evolving scenario in tissue use for ocular surgery has to be taken into consideration, especially regarding eye banks facing current and futures changes in tissue preservation, storage and indications.

Implementation and certification of ISO 9001:2015 seal in human tissue bank HCFMRP-USP.

The Quality Management System has been a management technology applied to guarantee the quality of processes and products of a given organization. Thus, ISO 9001:2015 certification assists organizations that want to develop, implement, maintain, and improve a quality management system to enable process improvements and assessments to meet the needs of its customers. This experience report addresses the implementation and certification of the ISO 9001:2015 quality management seal at the Human Tissue Bank of the Ribeirão Preto Clinical Hospital (HCRP) at the University of São Paulo (USP) at Ribeirão Preto Medical School (FMRP)-Brazil. In 2018, the Human Tissue Bank, in partnership with HCRP, received consultancies from PRIMEMODE. The consulting consisted of visits that elucidated the processes to the employees of the Tissue Bank, enabling them to clarify the applicability of all items of the standard. In March 2019, the Tissue Bank received the audit visit and was certified with the ISO 9001:2015 Seal by the Carlos Alberto Vanzolini Foundation. The Tissue Bank aims to provide human tissues for transplantation and research from organ donors. It has a complex physical structure within the required health and legal standards. Also, now it has a quality management seal. The certification guarantees the process organization and the high quality standard of the supplied tissues.