The establishment of a network of European human research tissue banks

This is a report of a workshop held on the establishment of human research tissue banking which was held in Levi, Finland 21–24 March 2002.There were 21 participants from 7 European countries. This meeting was attended by representatives from academia, research tissue banks and from the Biotech and Pharmaceutical Industries. The principal aim of the workshop was to find a way to progress the recommendations from ECVAM workshop 44 (ATLA 29, 125–134,2001) and ECVAM workshop 32 (ATLA 26, 763–777, 1998). The workshop represented the first unofficial meeting of the European Network of Research Tissue Banks (ENRTB) steering group. It is expected that in the period preceding the next workshop the ENRTB steering group will co-ordinate the ethical,legislative and organisational aspects of research tissue banking. Key issues dealt with by the Levi workshop included the practical aspects of sharing expertise and experiences across the different European members. Such collaboration between research tissue banks and end users of such material seeks to ultimately enable shared access to human tissue for medical and pharmaco-toxicological research while maintaining strict adherence to differences in legal and ethical aspects related to the use of human tissue in individual countries. This revised version was published online in July 2006 with corrections to the Cover Date.     

Fourth meeting of the European Network of Research Tissue Banks – Future strategy to increase collaborations in the supply of human tissue for biomedical research

This report records the Fourth meeting of the European Network of Research Tissue Bank (Brussels, 18th March 2004) which was attended by Mel Read MEP. The existing membership of this informal group represents European Human Research Tissue Bankers, biomedical researchers seeking access to human tissue and allied groups including animal welfare representatives. This Fourth meeting provided a forum to update members on individual activity in this area. A particular focus of this meeting was to consider the status of this group and future affiliations to increase the profile and activity of this Network. This meeting addressed differences in legislative and ethical requirements governing the use of human tissue in biomedical research in the different countries represented. Future activity of the ENRTB, planned at this meeting, will target harmonisation of current differences which are currently barriers to increased access to human tissue for biomedical research. Through the harmonisation of procurement, processing and distribution of human tissue specimens the ENRTB will provide a mechanism to benefit human health through increased use of human tissue in pharmacotoxicological studies and the associated replacement of animal tests.     

Access to organs and tissues for research from the organ donor pool within the UK

The donor organ transplant scenario offers one potential route to access high-quality human organs and tissues for research. There are well-established networks for co-ordinating organ donation events across many countries, including the UK, which include robust mechanisms for obtaining consent for ethically-approved research. Within the UK, the challenge for the next few years is to facilitate this research donation with respect to regulatory pathways directed by the Human Tissue Act, which covers all aspects of access to human tissues.     

Status quo of management of the human tissue banks in Taiwan

As the technologies associated with transplantation and biological tissue engineering continue to advance, human cells and tissues form an integral part to the practice of regenerative medicine. The patient’s use of tissues entails the risk of introducing, transmitting and spreading communicable diseases. To prevent such risk and to ensure that the human organs, tissues and cells remain intact and functional after being handled and processed, the transplanted tissues must be subject to good management standards through all stages of collection, screening, processing, storage and distribution as the safety of the users is of the utmost importance. On February 2009, the government of Taiwan promulgated the Regulations for Administration on Human Organ Bank that requires all human tissues banks to adhere to the Good Tissue Practice for Human Organ, Tissue and Cell in terms of establishment and operation in order to cope with the international management trend and the development and management need of the domestic industry. Six years have passed since the law became effective. This article seeks to introduce the current management mechanism and status quo of management of human tissue banks in Taiwan. We also conducted statistical analysis of the data relating to the tissue banks to identify potential risks and the room for improvement. The study concludes that human tissue banks in Taiwan are on the right track with their management practice, leading to a state of steady development and progress.     

The importance of ethic in the field of human tissue banking

A tissue bank is accountable before the community in fulfilling the expectations of tissue donors, their families and recipients. The expected output from the altruistic donation is that safe and high quality human tissue grafts will be provided for the medical treatment of patients. Thus, undertakings of tissue banks have to be not only authorised and audited by national competent health care authorities, but also comply with a strong ethical code, a code of practices and ethical principles. Ethical practice in the field of tissue banking requires the setting of principles, the identification of possible deviations and the establishment of mechanisms that will detect and hinder abuses that may occur during the procurement, processing and distribution of human tissues for transplantation. The opinions and suggestions manifested by the authors in this paper may not be necessarily a reflection of those within the institutions or community they are linked to.     

Current concepts for tissue transplant services for developing countries

Cell and Tissue Banking - The transplantation of tissues can save lives and re-establish vital functions, where no alternatives of comparable effectiveness exist. This has led to establishment of...     

Human research tissue banks: the ATRA Project for establishing a human research tissue bank in switzerland

A large number of experiments in biomedical research are carried out on tissues, but, even though the results should be applicable to humans, these tissues are mainly of animal origin. The difficulty encountered in obtaining human organs and tissues is an acknowledged problem: not enough human tissues are available to meet research needs. We are introducing the ATRA Project, with the purpose of supporting progress in biomedical research in Switzerland through the establishment of one or more human tissue banks, which will be able to find, treat, preserve and supply human material. Where similar projects have already been launched, concerns have been expressed that donation for research purposes might compete with donation for transplantation, but most organs and tissues are in any case non-transplantable. Surplus surgical tissue is considered "sanitary waste", and must be treated according to specific regulations for collection, packaging, transport, treatment and disposal. A human tissue bank would not only abate the costs of treating sanitary waste, but would actually turn what is now considered waste into a resource which could be used to save human and animal lives.     

The current limitations on tissue banking from an academic perspective

For research on human physiology and pathologies the most relevant results come from human tissue, necessitating the creation of more tissue banks. This need is acknowledged by academics, clinical researchers and the pharmaceutical industry. For academics, the major obstacles to establishing tissue banks are the somewhat cumbersome ethical procedures, a perceived lack of demand for human tissue and insufficient knowledge about supply and its demographic differences. The causes are inter-related: confusing and time-consuming ethics applications cause some researchers to avoid human tissue work and expend research efforts on animal studies, leading to a false presumption of a lower level of demand for human tissue. Lack of knowledge about why rates of donation are low, and why there are differences in donation for different organs, leads to an uncertainty about supply. This too poses a problem for tissue bank establishment, and further research into this area is required.     

Mechanisms of tissue fusion during development

Tissue fusion events during embryonic development are crucial for the correct formation and function of many organs and tissues, including the heart, neural tube, eyes, face and body wall. During tissue fusion, two opposing tissue components approach one another and integrate to form a continuous tissue; disruption of this process leads to a variety of human birth defects. Genetic studies, together with recent advances in the ability to culture developing tissues, have greatly enriched our knowledge of the mechanisms involved in tissue fusion. This review aims to bring together what is currently known about tissue fusion in several developing mammalian organs and highlights some of the questions that remain to be addressed.     

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in India

The banking of tissues such bone and skin began in India in the 1980s and 1990s. Although eye banking started in 1945 there was little progress in this field for the next five decades. As part of the IAEA/RCA program to use ionising radiation for the sterilisation of biological tissues in Asia and the Pacific Region, the Tata Memorial Hospital (TMH) in 1986 decided to set up a tissue bank in Mumbai funded by the Government of India. The TMH Tissue Bank became operational in January 1988, and stands as a pioneering effort in the country to provide safe, clinically useful and cost-effective human allografts for transplantation. It uses the IAEA International Standards on Tissue Banking. All the grafts are sterilised terminally by exposure to a dose of 25 kGy of gamma radiation, which has been validated as recommended by the IAEA Code of Practice for the Radiation Sterilisation of Tissues Allografts: Requirements for Validation and Routine Control. The TMH Tissue Bank is registered with the Maharashtra State Health Authorities, and in May 2004, it became India’s first Tissue Bank to receive ISO 9001:2000 certification of its Quality Management System. From 1989 to September 2007, the TMH Tissue Bank has supplied 11,369 allografts to 310 surgeons operating in 69 hospitals in Mumbai and 56 hospitals in other parts of India. These numbers have been limited by difficulties with the retrieval of tissues from deceased donors due to inadequate resources and tissue donation policies of hospitals. As the Government of India representative in the IAEA program, the TMH Tissue Bank has promoted and co-coordinated these activities in the country and the development of tissue banks using radiation sterilisation of tissue grafts. Towards this end it has been engaged in training personnel, drawing up project proposals, and supporting the establishment of a Tissue Retrieval Centre in Mumbai. Currently it networks with the Zonal Transplant Co-ordination Centre of the Government of Maharashtra, and the newly instituted National Deceased Donor Transplantation Network, which will work with the Government of India to set up rules and regulations for organ and tissue donation and transplantation.     

Evaluation of tissue discards after implementation of anti-HBc test in a tissue bank in Spain

The recent introduction as a minimum test required in The Guide to Safety and Quality Assurance for Organs, Tissues and Cells (Council Europe) and the Directive 2004/23/EC applied to donation, procurement, testing, processing, preservation, storage and distribution of human cells and tissues make necessary the implementation of these markers in all European Tissue Establishments. In this study we have analyzed the impact in tissues discard by introducing anti-HBc in a European Tissue Establishment in a country with a high prevalence of HBV infection. The adoption of this exclusion criteria in this region results in acceptably rejection rates among tissue donors, although some studies are needed on basis a risk assessment to determine the eligibility for clinical use.     

Cadaveric Tissue Supply to the Commercial Sector For Research: Collaboration between NHS Pathology and NBS Tissue Services in the U.K., Extending the Options for Donors

The Peterborough Hospital Human Tissue Bank (PHHTB) and National Blood Service Tissue Services (London and South East Zone) (NBSTS) operate within the U.K. National Health Service (NHS) and have a system in place to retrieve cadaveric tissues for commercial sector research. The collaboration meets the aims of PHHTB and NBSTS and is legal, ethical and safe. This paper presents the results of the first 20 successful retrievals referred from NBSTS to PHHTB. Cadaveric retrieval of tissue for research extends the options for donors and their relatives. The research option is particularly welcomed in cases where clinical retrieval for tissue transplantation is contraindicated. We believe the system is applicable to other centres.     

Human and animal research guidelines: aligning ethical constructs with new scientific developments

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries.     

Ersatzgewebe aus Bioreaktoren

Induced Stem Cells and Tissue Engineering Not only ethical reservations and restrictive laws direct medically oriented stem cell research towards adult stem cells, facilitated by new methods to reprogram differentiated cells back to proliferating progenitors. This allows new therapies with autologous, immunologically tolerant cells and tissues. In bioreactors autologous tissues are grown to replace, for instance, burned skin, cartilaginous elements, and heart valves. Even almost complete eyes, however in an embryonic state, can develop from stem cells in culture by self organization. Finally the German laws related to stem cell research are reviewed.     

Initiation of coagulation by tissue factor

Tissue factor (TF) is an integral membrane glycoprotein which functions as an initiator of coagulation. Furthermore, it is probably the principal biological initiator of this essential hemostatic process. This article reviews the studies which form the basis for these assertions. The work on TF is traced from the 19th century discovery of the thromboplastic activity of tissues to the recent purification of the protein from bovine and human tissues and the isolation cDNA clones coding from human TF. The features of TF structure and function which tailor it to the role of initiator of the coagulation cascade are considered. For example, cell-surface TF and factor VII, the plasma serine proteases zymogen, form a proteolytic complex without prior proteolysis of either component. In addition, a kinetic model for the molecular mechanism of TF-initiated clotting is reviewed. The factors which control the expression of TF procoagulant activity by cultured cells are examined in light of the hypothesized role of TF in normal hemostasis. Also, the potential pathological consequences of aberrant TF expression, i.e., thrombosis and hemorrhage, are explored.     

Overview on radiation and tissue banking in Latin America

The International Atomic Energy Agency (IAEA) played an important role in the establishment of new tissue banks and the improvement of already existing ones in Latin America. The Agency strongly supported, through regional, interregional and national technical cooperation projects, providing equipment, expert missions and training for the production and application of human tissues for transplantation. From 1999 to 2005 five regional courses were given in Buenos Aires under the modality of 1-year distance learning training courses and 1-week face to face courses. The courses were organized by the IAEA, through the National Atomic Energy Commission (CNEA) and the Faculty of Medicine of Buenos Aires University as Post Graduate Specialization Course. In 2005 the Latin American countries joined with Spain and Portugal, and created the Ibero American Network Council of Donation and Transplant (Red Consejo Iberoamericano de Donación y Trasplantes—RCIDT). The objective of this network is to cooperate among twenty-one Ibero American countries in organizational and legislative aspects, training of professionals, and ethical and social issues related to the donation and transplantation of organs, tissues and cells. The members of this Network work actively to harmonize the regulations and the control of donation and transplantation of human organs, tissues and cells. At present, in Latin America, more than 220 facilities of tissues banks are operating and tissue allografts are being produced by single and multi-tissue banks. The efforts made by the governments and professionals from the region allow the tissue banks to operate under quality systems and introduce new technologies.     

Quantitating tissue specificity of human genes to facilitate biomarker discovery

We describe a method to identify candidate cancer biomarkers by analyzing numeric approximations of tissue specificity of human genes. These approximations were calculated by analyzing predicted tissue expression distributions of genes derived from mapping expressed sequence tags (ESTs) to the human genome sequence using a binary indexing algorithm. Tissue-specificity values facilitated high-throughput analysis of the human genes and enabled the identification of genes highly specific to different tissues. Tissue expression distributions for several genes were compared to estimates obtained from other public gene expression datasets and experimentally validated using quantitative RT-PCR on RNA isolated from several human tissues. Our results demonstrate that most human genes ( approximately 98%) are expressed in many tissues (low specificity), and only a small number of genes possess very specific tissue expression profiles. These genes comprise a rich dataset from which novel therapeutic targets and novel diagnostic serum biomarkers may be selected.     

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.