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PubMed2005

The development of common data elements for a multi-institute prostate cancer tissue bank: the Cooperative Prostate Cancer Tissue Resource (CPCTR) experience.

BACKGROUND: The Cooperative Prostate Cancer Tissue Resource (CPCTR) is a consortium of four geographically dispersed institutions that are funded by the U.S. National Cancer Institute (NCI) to provide clinically annotated prostate cancer tissue samples to researchers. To facilitate this effort, it was critical to arrive at agreed upon common data elements (CDEs) that could be used to collect demographic, pathologic, treatment and clinical outcome data. METHODS: The CPCTR investigators convened a CDE curation subcommittee to develop and implement CDEs for the annotation of collected prostate tissues. The draft CDEs were refined and progressively annotated to make them ISO 11179 compliant. The CDEs were implemented in the CPCTR database and tested using software query tools developed by the investigators. RESULTS: By collaborative consensus the CPCTR CDE subcommittee developed 145 data elements to annotate the tissue samples collected. These included for each case: 1) demographic data, 2) clinical history, 3) pathology specimen level elements to describe the staging, grading and other characteristics of individual surgical pathology cases, 4) tissue block level annotation critical to managing a virtual inventory of cases and facilitating case selection, and 5) clinical outcome data including treatment, recurrence and vital status. These elements have been used successfully to respond to over 60 requests by end-users for tissue, including paraffin blocks from cases with 5 to 10 years of follow up, tissue microarrays (TMAs), as well as frozen tissue collected prospectively for genomic profiling and genetic studies. The CPCTR CDEs have been fully implemented in two major tissue banks and have been shared with dozens of other tissue banking efforts. CONCLUSION: The freely available CDEs developed by the CPCTR are robust, based on "best practices" for tissue resources, and are ISO 11179 compliant. The process for CDE development described in this manuscript provides a framework model for other organ sites and has been used as a model for breast and melanoma tissue banking efforts.

Computational Biology↗
PubMed2006

Quality control in tissue banking--ensuring the safety of allograft tissues.

DESPITE FEDERAL REGULATIONS for tissue-banking practices, inadequate quality control led to the largest allograft tissue recall in history in October 2005. THE RECALL INCLUDED all allograft tissues obtained from 761 donors and distributed by five tissue banks. Many of these tissues already had been implanted and were unrecoverable. THIS ARTICLE DESCRIBES the many tissue-banking industry variables, including donor selection and testing and tissue recovery, processing, and preservation. QUESTIONS THAT HEALTH CARE providers can ask to determine which tissue banks' quality control measures best ensure the safety of the allografts they provide also are included.

Communicable Disease Control↗
PubMed1995

Teamwork and leadership: the development of the National Psoriasis Tissue Bank.

The National Psoriasis Tissue Bank is the first tissue bank of its kind for psoriasis, providing cell lines and DNA samples to researchers worldwide who are actively seeking to locate the genes that cause psoriasis. Developed by a multidisciplinary, multi-institutional team, the tissue bank is also an interesting study in teamwork and leadership, as well as an excellent example of the expanding roles and opportunities for nurses.

Cell Line↗
PubMed2006

An informatics model for tissue banks--lessons learned from the Cooperative Prostate Cancer Tissue Resource.

BACKGROUND: Advances in molecular biology and growing requirements from biomarker validation studies have generated a need for tissue banks to provide quality-controlled tissue samples with standardized clinical annotation. The NCI Cooperative Prostate Cancer Tissue Resource (CPCTR) is a distributed tissue bank that comprises four academic centers and provides thousands of clinically annotated prostate cancer specimens to researchers. Here we describe the CPCTR information management system architecture, common data element (CDE) development, query interfaces, data curation, and quality control. METHODS: Data managers review the medical records to collect and continuously update information for the 145 clinical, pathological and inventorial CDEs that the Resource maintains for each case. An Access-based data entry tool provides de-identification and a standard communication mechanism between each group and a central CPCTR database. Standardized automated quality control audits have been implemented. Centrally, an Oracle database has web interfaces allowing multiple user-types, including the general public, to mine de-identified information from all of the sites with three levels of specificity and granularity as well as to request tissues through a formal letter of intent. RESULTS: Since July 2003, CPCTR has offered over 6,000 cases (38,000 blocks) of highly characterized prostate cancer biospecimens, including several tissue microarrays (TMA). The Resource developed a website with interfaces for the general public as well as researchers and internal members. These user groups have utilized the web-tools for public query of summary data on the cases that were available, to prepare requests, and to receive tissues. As of December 2005, the Resource received over 130 tissue requests, of which 45 have been reviewed, approved and filled. Additionally, the Resource implemented the TMA Data Exchange Specification in its TMA program and created a computer program for calculating PSA recurrence. CONCLUSION: Building a biorepository infrastructure that meets today's research needs involves time and input of many individuals from diverse disciplines. The CPCTR can provide large volumes of carefully annotated prostate tissue for research initiatives such as Specialized Programs of Research Excellence (SPOREs) and for biomarker validation studies and its experience can help development of collaborative, large scale, virtual tissue banks in other organ systems.

Databases as Topic↗
PubMed2006

Consent in crisis: the need to reconceptualize consent to tissue banking research.

The issues surrounding consent to tissue banking research in Australia are complex and have created a forum of intense debate, thus providing a window of opportunity to critically appraise and challenge standard models of consent for research in general and for tissue banking research in particular. The usual practical difficulties associated with meeting the criteria for valid consent to research (including adequate information provision and voluntariness) are amplified in the case of tissue banking research. A number of models, based on widely accepted ethical principles, have been proposed to improve the process of obtaining consent to tissue banking research, all of which assume that the consent of individual tissue donors is needed to meet the criteria for valid consent. Feminist and communitarian theories use many of the same criteria for valid consent but interpret these criteria differently and de-emphasize the importance of individual autonomy as the central criterion for valid consent. An enriched model of consent incorporating feminist and communitarian ideas could satisfy the currently accepted criteria for valid consent while also furthering a broader range of community values.

Biomedical Research↗
PubMed1993

Organization and research applications of the U.K. Multiple Sclerosis Society Tissue Bank.

The Multiple Sclerosis Society Tissue Bank contains post-mortem central nervous system tissue from over 100 clinically and neuropathologically well-documented multiple sclerosis (MS) cases, and from normal control subjects. This bank is a resource centre which provides histologically screened snap-frozen material for immunological, neurochemical and nucleic acid studies in our own and other MS laboratories in Europe and the USA. In addition to immunopathological studies, Tissue Bank material has been used to investigate changes in CNS-specific proteins and lipids in MS plaques and responses of oligodendrocytes and astrocytes to the inflammatory demyelinating process. MS lesions detected in unfixed post-mortem brain and spinal cord by magnetic resonance imaging techniques prior to dissection have been characterized histologically and biochemically. A computer database on Tissue Bank post-mortem cases has been established to link clinical, pathological and scientific aspects of MS research.

Brain↗
PubMed2003

Tissue banking in australia.

The legal structure for the regulation of tissue banking has existed for many years. In Australia, the donation of human tissue is regulated by legislation in each of the eight States and Territories. These substantially uniform Acts were passed in the late 1970's and early 1980's, based on model legislation and underpinned by the concept of consensual giving. However, it was not until the early 1990's that tissue banking came under the notice of regulatory authorities. Since then the Australian Government has moved quickly to oversee the tissue banking sector in Australia. Banked human tissue has been deemed to be a therapeutic good under the Therapeutic Goods Act 1989, and tissue banks are required to be licensed by the Therapeutic Goods Administration and are audited for compliance with the Code of Good Manufacturing Practice- Human Blood and Tissues. In addition, tissue banks must comply with a myriad of other standards, guidelines and recommendations.

Journal Article↗
PubMedDate not supplied

Soft tissue for allograft reconstruction of the human knee: a survey of the American Association of Tissue Banks.

With increasing use and availability of musculoskeletal soft tissue allografts, orthopaedic surgeons need current knowledge about allograft processing, costs, and availability. In conjunction with the American Association of Tissue Banks, a comprehensive survey consisting of specific questions on several topics in tissue banking was sent to 42 member banks or banks undergoing accreditation review that distribute musculoskeletal tissues. Donors came from organ procurement organizations, coroners' offices, hospital morgues, and donations; the average age of the donors was 35. Most of the 36 tissue banks responding to the questionnaire harvest patellar and Achilles tendons. Patellar tendon demand exceeded supply. Tissue processing was done by outside organizations approximately 50% of the time. Of the four types of tissue sterilization processes performed, gamma irradiation was the most common. Doses of sterilizing gamma irradiation varied from 1 to 3.5 mrad. The average approximate costs of fresh-frozen tissue were $800 for patellar tendon allograft, $615 for Achilles tendon, and $640 for menisci. There was no consensus of opinion of how to size or sterilize meniscal allografts. As demand increases for soft tissue allografts, it is essential that the orthopaedic surgeon is knowledgeable about the clinical impact of tissue banking.

Adolescent↗
PubMed2005

Tissue banking in South Africa: a 19-year history.

The establishment of a Tissue Bank and the science of Tissue Banking in South Africa started in the 1960s and is still developing. This article describes the development and growth of Tissue Banking in South Africa. The current emphasis is to supply viable bone products that have been produced under the best possible quality controlled circumstances; with the collaboration between different Organ Donation Organisations. Through collaboration, a dramatic increase in the number of donors was noted over the years. Concurrently, there was a dramatic increase in the usage of different allograft products and now necessitates the development of new graft materials for expanding patient options. As an ongoing concern, the Tissue Bank in South Africa experienced an ever increase in costs to enhance quality/safety controls: increase in historical patient information, documentation and serological testing in a population struggling to control HIV. To date, the South African Tissue Bank has not experienced any untoward patient incidence since the 1960s and currently is getting over 500 donors per year.

History, 20th Century↗
PubMed2003

Tissue banking in India: gamma-irradiated allografts.

In India, the procurement of tissues for transplantation is governed by the Transplantation of Human Organs Act, 1994. Although this law exists, it is primarily applied to organ transplantation and rules and regulations that are specific to tissue banking which have yet to be developed. The Tata Memorial Hospital (TMH) Tissue Bank was started in 1988 as part of an International Atomic Energy Agency (IAEA) programme to promote the use of ionising radiation for the sterilisation of biological tissues. It represents the Government of India within this project and was the first facility in the country to use radiation for the sterilisation of allografts. It is registered with the Health Services Maharashtra State and provides freeze-dried, gamma irradiated amnion, dura mater, skin and bone. The tissues are obtained either from cadavers or live donors. To date the TMH Tissue Bank has provided 6328 allografts which have found use as biological dressings and in various reconstructive procedures. The TMH Tissue Bank has helped initiate a Tissue Bank at the Defence Laboratory (DL), Jodhpur. At present these are the only two Banks in the country using radiation for the terminal sterilisation of preserved tissues. The availability of safe, clinically useful and cost effective grafts has stimulated innovative approaches to surgery. There is an increased demand for banked tissues and a heightened interest in the development of tissue banks. Inadequate infrastructure for donor referral programmes and the lack of support for tissue transplant co-ordinators however, continue to limit the availability of donor tissue.

Journal Article↗
PubMed2003

IAEA/NUS Distance Learning Diploma Training Course for Tissue Bank Operators - Past, Present and Future.

National University Hospital (NUH) Tissue Bank as the Regional Training Centre for Asia Pacific Region provided National University of Singapore (NUS) Diploma Course in Tissue Banking - a long distance diploma course since 1997. To date, five batches have participated - 94 tissue bank operators. Sixty-three tissue bank operators have convocated with NUS Diploma in Tissue Banking.From Regional Co-operative Agreement (RCA) Project, RAS 7/008 technology transfer was effected to Latin America and to Africa.A Memorandum of Understanding has been signed between International Atomic Energy Agency (IAEA) and NUS in July 2002 making Singapore the International Training Centre. An Internet NUS Diploma Course in Tissue Banking has been developed by IAEA and NUS. The first on-line diploma course will be launched in 2003.

Journal Article↗
PubMed2003

Setting up a Tissue Bank in India: The Tata Memorial Hospital Experience.

In India, the procurement of tissues for transplantation is governed by the Transplantation of Human Organs Act, 1994. However, although this law exists, it is primarily applied to organ transplantation and rules and regulations that are specific to tissue banking have yet to be developed.The Tata Memorial Hospital (TMH) Tissue Bank was started in 1988 as part of an International Atomic Energy Agency (IAEA) programme to promote the use of ionising radiation for the sterilisation of biological tissues. It represents the Government of India within this project and was the first such facility in the country. It is registered with the Health Services Maharashtra State and provides lyophilised amnion, dura mater, skin and bone that have been terminally sterilised with exposure to 25 kGy of gamma radiation from a Cobalt 60 source. These are obtained either from cadavers or live donors.To date the TMH Tissue Bank has provided 6328 allografts for use as biological dressings or in various reconstructive procedures.The TMH Tissue Bank has helped initiate a Tissue Bank at the Defence Laboratory (DL), Jodhpur. At present these are the only two Banks in the country using radiation for terminal sterilisation of banked tissues.The availability of safe, clinically useful and cost effective grafts have resulted in changes in surgical treatment with a concomitant increase in demand for grafts and an interest in developing more tissue banks. The availability of donor tissue however, continues to be a major limitation.

Journal Article↗
PubMed2001

[Associations of patients and tissue banks].

Research dealing with tissue is more important to day than ever. Techniques of molecular genetics have indeed permitted the identification of a large number of new proteins that have now to be localised in the tissue and in the cell, in health and disease. This step has to be made in order to elaborate the adequate animal models in which new therapeutics can be tested. In France, however, human tissue samples have become difficult to obtain. Many factors contributed to this situation. Autopsies are now exceptionally performed. Doctors feel confident in their diagnosis and express rarely the need to control it. Families are opposed to post mortem more strongly than before, especially when the reasons for performing it can not be explained before the death of the patient. French law now makes the explicit consent of the patient mandatory before any research. This practically limits all post mortem investigations to those that had been planned before death. The possibility of giving tissue post mortem to allow research has to be publicised, particularly by associations of patients. The organisation that should manage to collect and store the samples at a large scale and over the whole country is lacking. Its structure is still discussed: should it be supported by the state itself, by private funding, possibly by the associations of patients themselves? Patients Associations are ready to play a crucial role: they realised that the present system was inefficient, they are presently trying to organise tissue banks; they will finally have to explain to their members why they should care for research, how they could help and how they will have to accept the absence of immediate spectacular results.

France↗
PubMed2000

The US Navy Tissue Bank: 50 Years on the Cutting Edge.

The US Navy Tissue Bank was established in 1949 by Dr. George Hyatt, an orthopaedic surgeon at the Naval Medical Center in Bethesda, Maryland. The Navy program was the first of its kind in the world and established many of the standards that are followed today. During the 1950s, the identification of appropriate donor criteria for tissue donation, the development of procurement and processing methods, the establishment of a graph registry and documentation and the clinical evaluation of a variety of tissues were pioneered at this facility. Cryopreservation, freeze-drying, irradiation sterilization of tissue, as well as immunological principles of tissue transplantation, were developed during the 50 years of research and development by Navy scientists. Organ preservation, cadaveric bone marrow recovery and immunosuppressive protocols were also developed at the Navy Tissue Bank. The Navy was also instrumental in the establishment of the National Marrow Donor Program and the American Association of Tissue Banks in the US.Although the Navy Tissue Bank has ceased activity after 50 years of excellence, it should be recognized as the first standard setter for the world community of tissue banks.

Journal Article↗
PubMed2004

Musculoskeletal tissue banking in Singapore: 15 years of experience (1988-2003).

PURPOSE: To report 15 years' experience of musculoskeletal tissue banking by the National University Hospital Tissue Bank. METHODS: This study describes the development of Singapore's national bone bank since its establishment in 1988. The bone bank's protocol follows guidelines recommended by the American Association of Tissue Banks and the European Association of Tissue Banks using strict donor selection criteria. Informed consent is obtained from all potential donors for tissue procurement and laboratory tests. Detailed medical history, thorough clinical examination, and chart review is performed for consenting donors. Suitable donors are subjected to tests for hepatitis B, hepatitis C, syphilis, and culture/sensitivity test of tissue for aerobic and anaerobic organisms. For living donors, repeat testing for AIDS and hepatitis C is performed at least 180 days after procurement. Tissue procurement is performed under sterile conditions. Small tissues are procured using the 'sterile double jar technique' and long bones using the 'sterile triple wrap technique', both developed by the author. Deep-frozen bones are gamma irradiated at 25 kilograys. Morsellised bones are lyophilised and gamma irradiated. Meticulous preparation for grafts is performed during transplantation. Antibiotic prophylaxis is used for 2 weeks. RESULTS: The bank maintains a good quality control. In January 2003, it was accredited ISO 9001 status. Up to June 2003, it has procured 440 bones from 440 living donors and 1055 allografts from 63 deceased donors. 854 musculoskeletal transplantations have been performed using tissues processed by the bank. Complication rate encountered was only 2.2%. CONCLUSION: The tissue bank provides high-quality allografts for safe tissue transplantations.

Bone Transplantation↗