The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking)

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In the present globalised times, where people travel more easily and live abroad, many countries are accepting non-resident living donors.

Tissue Typing

This resolution is aimed at protecting non-resident living donors who, for a number of reasons — economic, emotional, cultural or physical — may be particularly vulnerable, and whose post-donation care and follow-up may be difficult to guarantee. This resolution provides much-needed guidance for all countries accepting non-resident organ donors into their living donation programmes and details rigorous donor selection, evaluation and follow-up measures that these countries should set in place to ensure the protection and well-being of these donors.

The aim is to provide recommendations to member states on the establishment of harmonised national living donor registries with the view to facilitating international data sharing. It also contains a glossary of terms, intended to provide clarity on the way each parameter should be measured or collected and to facilitate harmonised international data sharing. Both guides are the result of the efforts of experts from all over the world who have contributed different aspects and have done a tremendous job in reviewing the literature and extracting knowledge from numerous international guidelines, collaborative projects and diverse publications and websites, with the aim of providing recommendations based on available evidence and expert opinion.

For more information, please visit our dedicated website. Monitoring of practices in the member states is evidently needed to allow transparency and international benchmarking. This publication summarises comprehensive data provided by national focal points NFP designated by governments, on donation and transplantation activities, management of waiting lists, organ donation refusals and authorised centres for transplantation activities.

As of today, the Newsletter Transplant provides information from over 70 countries worldwide, including Council of Europe member states, observer countries and observer networks e. To avoid duplication of efforts, the Newsletter Transplant database is connected with other international data collection projects, e.

The Newsletter Transplant has evolved into a unique official source of information that continues to inspire policies and strategic plans globally.

Organ donation rates vary greatly among the Council of Europe member states. Recent data show that some countries have been able to increase their donation rates substantially during the last decade. Internationally, there have been numerous initiatives undertaken to promote learning from best practice and to identify the key factors that may influence donation rates.

Yet only limited information is available about the specific measures that have been implemented in member states which have succeeded in increasing donation rates. Subsequently, once the different strategies leading to increases in deceased donation rates have been identified, it is planned to develop guidance to support member states in choosing the strategies best suited to their particular situation. Trafficking in human beings for the purpose of organ removal HTOR and trafficking in human organs THO are real and growing problems all over the world.

The most frequently encountered form of trafficking related to organ transplantation involves living unrelated donors. However, deceased donors can also be a source of trafficked organs. The Committee on Bioethics DH-BIO and the European Committee on Organ Transplantation CD-P-TO of the Council of Europe are concerned by suggestions made, sometimes in international forums, that some forms of commercialisation of human organs could be accepted in response to the shortage of organs for transplantation.

In this context, the DH-BIO and the CD-P-TO strongly emphasise the need to respect the fundamental legal principle that the human body and its parts shall not, as such, give rise to financial gain. Human organs must not therefore be bought or sold or give rise to financial gain or comparable advantages for the person from whom they have been removed or for a third party. Organ shortages, or lack of access to a deceased donor programme, have encouraged trafficking in human beings for the purpose of organ removal HTOR and trafficking in human organs THO , often involving patients seeking to receive an organ transplant abroad.

Patients who have received an organ transplant abroad either through proper travel for transplantation or through unethical transplant tourism, typically return to their country of origin shortly after the procedure to receive post-transplantation care. At the same time, not all those that travel abroad for transplantation may be involved in illicit activities.

Organ transplantation

Ethical travel for transplantation — as opposed to transplant tourism — can take place in exceptional circumstances and be linked to personal or family reasons or to the availability of translation services in the context of agreements between the governments of the countries involved.

Such ethical travel for transplantation should never entail transplant-related crimes or reduce the ability of countries of destination to cover the transplantation needs of their own patients. Whatever the scenario, it is clearly established that the systematic and appropriate registration in national transplant registries of all patients who undergo organ transplantation allows transparency, connection between traceability and biovigilance systems and enables the evaluation of the long-term outcomes of transplantation. These benefits are desirable not only for patients having received an organ transplant domestically but also for those who have received a transplant abroad.

In the latter case, registration in national transplant registries would also allow gathering of up-to-date epidemiological information and provision of personalised care depending on the country where the patient has received the organ transplant. A survey to evaluate the current situation in member States is on-going to analyse current practices and guide the elaboration of future recommendations.

Later work evidenced that reporting transplant centres should not be put in the position to decide if their patients had been involved in illicit transplant-related activities. Thus, it was decided that the data collection exercise would involve all patients having received a kidney transplant abroad, regardless of the nature of the transplant i. In this database, NFP provide information about all patients who travelled abroad to receive an organ transplant. The international exchange of information about these patients would help to better understand and analyse the phenomenon of travel for transplantation, to assess its dimension, and to identify possible hot spots of transplant tourism that deserve careful investigation by the concerned countries.

Transplantation: areas of work

In addition, it would help gain better knowledge of the profile of donors and recipients, the quality in the transfer of recipient care and its impact on post-transplant outcomes. From these efforts, it has become evident that experiences from countries with well-developed and established transplantation programmes should be shared and that national initiatives could provide models for increasing transplantation activity as well as for the implementation of safety and quality programmes throughout Europe. The BSA project contributed to the development of transplantation activities in the participant countries by providing expertise and guidance.

Thanks to the project, it was possible to analyse, assess and compare the different legal and organisational systems in these countries. The BSA project also evaluated the organ donation and transplantation programmes in each participant country and provided recommendations, guidelines and educational tools to enhance and consolidate them. This project aims at providing an updated review of the developments in donation after circulatory death DCD in the Council of Europe member states, with a focus on the quantity and type of donation and transplantation activities, the procedures used in clinical practice and the results of transplants performed with DCD donor organs.

The transplantation of vascularised composite allografts VCA is a treatment for complex tissue injuries and defects. Some deceased donors are tested many times by organ procurement organizations OPOs , eye banks, and tissue banks. Collecting and sharing of donor data are challenging in the absence of linked, unique identifying information for each donor e.

Epidemiologic data e. These data could be compared with information collected from blood screening tests for the same donors. Efforts were initiated to improve communication of recipient outcome data between the organ and tissue transplant communities in a pilot project. However, major issues remain to be addressed, such as standard definitions and incentives for participation, before a useful system could be deployed nationally Such data could be used in evaluating effectiveness of current donor screening and testing strategies and developing standardized research methods for use in assessing donor evaluation tools.

Donor screening protocols should reduce the likelihood that tissues or organs that would transmit infection will be procured, while preserving availability avoiding false-positive test results. Effectiveness of current donor screening procedures has not been systematically evaluated. To develop data useful for assessing donor screening practices, high-quality data must be collected by using standardized protocols and assays of known performance characteristics. The nonuniformity of protocols used to screen donors among various organizations impedes critical assessment of donor evaluation protocols.

One initiative to bridge this gap is the development and validation of the proposed Uniform Donor History Questionnaire for Organ, Tissue, and Eye Donors Screening donors through donor history questionnaires can reduce transmission risk only to the degree of the accuracy and completeness of the information provided. This effort is limited by obtaining information by proxy i.

As a result, testing donor specimens for known transmissible organisms is required to further reduce risks by excluding the infected potential donor or guiding clinical care of recipients. Given the changing epidemiology of infection, a major challenge is developing new assays for emerging infectious diseases. New assay development is typically resource-intensive and too slow to reflect rapid shifts posed by epidemic disease e. New approaches to assay development and for evaluating such assays in organ and tissue donor populations, together with streamlined approaches to evaluating assay effectiveness in a manner appropriate to regulatory review, could enable more effective responses to threats of emerging infectious diseases.

There are immediate clinical needs e. A structured approach to addressing gaps in scientific knowledge, perhaps through an overarching Department of Health and Human Services strategy, is needed to enhance the safety of organ and tissue transplantation. The data required fall into several general areas as described below and summarized in Table 3. Baseline data for the number and types of tissue grafts distributed each year are available only through voluntary reporting to the American Association of Tissue Banks and are limited by a lack of coding and traceability after tissues are delivered to end users e.

Individual tissue banks rely on hospitals to return implant cards to assess use of allograft materials; compliance is voluntary and accuracy of the data is limited by incomplete return rates. Regulatory mandates require OPO and organ transplant programs to report extensive data to the OPTN on all solid-organ donors living and deceased , candidates on the waiting lists, and recipients. However, the discard rate of donor organs on the basis of microbiologic testing are not collected by OPTN and are retained at the local OPO rather than the national level.

Improved testing might change the denominator by increasing or decreasing the number of available allografts for transplantation; collection of these data is needed to guide decisions regarding optimal donor testing in organ transplantation 27 , The prevalence of infectious disease in potential organ and tissue donors has not been systematically evaluated. Studies of blood and organ donors suggest that the probability of viremia for HIV, HCV, HBV, and human T-cell lymphotropic virus in the United States is higher in tissue and organ donors than in first-time blood donors 29 , Prospective data collection is needed to define baseline seroprevalence in different donor populations; these data could be used to develop enhanced strategies for donor screening and testing to prevent disease transmission.

Data are needed regarding the transmissibility of potential pathogens by the type of organ or tissue transplanted. Current programs focus on excluding donors with risk factors for, or serologic markers of, blood-borne pathogens. The transmissibility of infection from organs or tissue donors with various nonspecific clinical syndromes e. Clinical data based on cultures and serologic studies and preclinical data from animal studies would enable more evidence-based decisions regarding donor eligibility. Processing methods vary with regard to diverse technologies and strategies used and types of tissue processed.

Tissue Banking and Transplantation, Ethical Issues in |

There are few data regarding the effect of tissue processing on decreasing or eliminating infectious organisms. Similarly, the effect on the risk for transmission of infection of antimicrobial drug therapy in donors or recipients is unknown. Increasingly, some organs notably kidneys undergo pump perfusion before implantation, but the effect of this manipulation on disease transmission is unknown. As discussed, standardizing and validating current donor screening tools is an essential first step in collecting and analyzing data for donor risk factors and in developing refined strategies for screening and testing donors.

Prospective studies comparing results of donor history questionnaires and those of microbiological testing should be performed to evaluate the effectiveness of donor-screening strategies. The availability of tissues and organs for transplantation could be increased without compromising safety. There is currently no established network or infrastructure for systematically collecting and analyzing organ and tissue donor data. Given the need for additional data to provide a scientific basis for evaluating and managing allograft donors and recipients, stakeholders must develop mechanisms to prioritize and implement joint research programs.

To perform the necessary research, the allograft transplant communities need to develop systems to harmonize labeling nomenclature and data elements product names and data that are contained on product labels , data collection methods, and mechanisms for data sharing. Elements needed to develop such a research infrastructure will include shared data repositories and software for collecting and analyzing surveillance data from donors and recipients; common epidemiologic data elements; and universal donor identifiers that link all allograft types to the original donor 25 , protocols, and standardized nomenclature.

Such a networked infrastructure is essential for rapid traceability of tissues and organs from common donors when donor-derived disease outbreaks occur in transplant recipients Newly developed datasets derived from these proposed research activities will enable development of risk assessment models similar to those used to characterize or predict infectious disease risks in blood donor populations Use of such models would further define targets for future research efforts and for clinical investigations of future outbreaks.

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Disease transmission through organ and tissue transplantation has been documented. Recognizing emerging infectious diseases in organ and tissue transplantation is challenging because of nonstandardization of donor evaluations and data collection, pathogen characteristics, and recipient surveillance.

Quantifying risk is further complicated by the absence of data regarding the factors affecting disease transmission. Gaps in systematic identification and characterization of the scope and magnitude of donor-derived infectious disease transmissions through organ and tissue transplantation remain a major hurdle to improvements in assessing risk and in developing more effective donor screening and testing strategies. These gaps can be addressed by a shared, overarching research agenda among the allograft communities. Areas of focus for research include compiling donor evaluation donor screening and testing and posttransplant recipient surveillance data and disease transmissibility data basic mechanisms and clinical factors and assessing the efficacy of mitigation strategies.

Prioritizing the research agenda can be best driven by collaboration between government i.

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  • Coding and traceability for cells, tissues and organs for transplantation.
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Each stakeholder has unique perspectives, experiences, and resources to share in enhancing the safety of organ and tissue transplantation and benefit the greatest number of recipients.

The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking) The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking)
The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking) The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking)
The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking) The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking)
The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking) The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking)
The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking) The Scientific Basis of Tissue Transplantation (Advances in Tissue Banking)

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