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In recent decades, considerable advances have been made in assuring the safety of blood transfusion and organ transplantation. However, with the increasing movement of medical products of human origin across international boundaries, there is a need to enhance global norms and governance. These products, which include blood, organs, tissues, cells, human milk and faecal microbiota, are today crucial for health care but they also pose unique risks due to their human origin, such as disease transmission and graft failure. Moreover, the demand for medical products of human origin often exceeds supply, leading to dependence on international supply chains, and emerging technologies like cell and gene therapy present further challenges because of their unproven efficacy and long-term risks. Current regulatory mechanisms, especially in low- and middle-income countries, are insufficient. The World Health Organization (WHO) has both the mandate and experience to lead the development of international quality and safety standards, consistent product nomenclature, and robust traceability and biovigilance systems. An international, multistakeholder approach is critical for addressing the complexities of how medical products of human origin are used globally and for ensuring their safety. This approach will require promoting uniform product descriptions, enhancing digital communication systems and leveraging existing resources to support countries in establishing regulations for these products. As illustrated by World Health Assembly resolution WHA77.4 on transplantation in 2024, WHO's ongoing efforts to ensure the safe, efficient and ethical use of medical products of human origin worldwide provide the opportunity to galvanize international cooperation on establishing norms. [phrase omitted] Au cours des dernieres decennies, des progres considerables ont ete realises pour assurer la securite des transfusions sanguines et des transplantations d'organes. Cependant, avec l'augmentation de la circulation de produits medicaux d'origine humaine par-dela les frontieres internationales, il est imperatif de renforcer la gouvernance et les normes mondiales. Ces produits, parmi lesquels figurent le sang, les organes, les tissus, les cellules, le lait maternel et le microbiote fecal, sont aujourd'hui essentiels pour les soins de sante. Mais ils comportent egalement des risques particuliers en raison de leur origine humaine, comme la transmission de maladies et le rejet de greffe. En outre, la demande en produits medicaux d'origine humaine depasse souvent l'offre, ce qui engendre une dependance vis-a-vis des chaines d'approvisionnement internationales, tandis que des technologies emergentes telles que la therapie cellulaire et genique posent de nouveaux defis en raison de leur efficacite non demontree et des risques a long terme. Les mecanismes de reglementation actuels sont insuffisants, surtout dans les pays a revenu faible et intermediaire. LOrganisation mondiale de la Sante (OMS) possede a la fois le mandat et l'experience necessaires pour mener le developpement de normes internationales de qualite et de securite, d'une nomenclature coherente des produits, ainsi que de systemes de tracabilite et de biovigilance solides. Une approche internationale et multilaterale est cruciale pour gerer la complexite liee a l'utilisation de produits medicaux d'origine humaine dans le monde et garantir leur innocuite. Cette approche devra prevoir la mise en place de descriptions de produits uniformes, l'amelioration des systemes de communication numeriques et l'exploitation des ressources existantes afin d'aider les pays a definir des regles pour de tels produits. Comme l'illustre la resolution WHA77.4 de l'Assemblee mondiale de la Sante sur la transplantation, emise en 2024, les efforts constants de l'OMS visant a assurer la securite, l'efficacite et l'usage ethique des produits medicaux d'origine humaine a travers le monde represente l'occasion de stimuler la cooperation internationale en matiere d'etablissement des normes. [phrase omitted] En las ultimas decadas, se han realizado avances considerables para garantizar la seguridad de las transfusiones de sangre y los trasplantes de organos. Sin embargo, con el creciente movimiento de productos medicos de origen humano a traves de las fronteras internacionales, es necesario reforzar las normas y la gobernanza mundiales. Estos productos, que incluyen sangre, organos, tejidos, celulas, leche humana y microbiota fecal, son hoy cruciales para la asistencia sanitaria, pero tambien plantean riesgos unicos por su origen humano, como la transmision de enfermedades y el fracaso de los injertos. Ademas, la demanda de productos medicos de origen humano suele ser superior a la oferta, lo que hace depender de las cadenas de suministro internacionales, y las tecnologias emergentes, como la terapia celular y genetica, plantean nuevos desafios debido a su eficacia no demostrada y a sus riesgos a largo plazo. Los mecanismos reguladores actuales, en especial en los paises de ingresos bajos y medios, son insuficientes. La Organizacion Mundial de la Salud (OMS) tiene tanto el mandato como la experiencia para liderar el desarrollo de estandares internacionales de calidad y seguridad, nomenclatura coherente de productos y sistemas solidos de trazabilidad y biovigilancia. Para responder a la complejidad del uso global de los productos medicos de origen humano y garantizar su seguridad, es fundamental un enfoque internacional que incluya a todas las partes interesadas. Este enfoque requerira promover descripciones uniformes de los productos, reforzar los sistemas de comunicacion digital y aprovechar los recursos existentes con el fin de ayudar a los paises a establecer normativas para estos productos. Como se ilustra en la resolucion WHA77.4 de la Asamblea Mundial de la Salud sobre trasplantes en 2024, los esfuerzos en curso de la OMS para asegurar el uso seguro, eficiente y etico de los productos medicos de origen humano en todo el mundo brindan la oportunidad de impulsar la cooperacion internacional en el establecimiento de normas., Introduction In recent decades, substantial progress has been made in assuring the safety of blood transfusion and the transplantation of medical products of human origin, which are also referred to [...]

Since 2012, the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) has required transplant centers to record the citizenship residency status of patients undergoing transplantation in the United States. This policy replaced the 5% threshold of the non-US citizen/nonresidents (NC/NR) undergoing organ transplantation that could result in an audit of transplant center activity. Since April 1, 2015, the country of residence for the NC/NR on the waitlist has also been recorded. We analyzed the frequency of NC/NR deceased donor organ transplants and waitlist registrations at all US transplant centers by data provided by UNOS for that purpose to the UNOS Ad Hoc International Relations Committee. During the period of 2013 to 2016, 1176 deceased donor transplants (of all organs) were performed in non-US citizen/non-US resident (NC/NR) candidates (0.54% of the total number of transplants). We focused on high-volume NC/NR transplant centers that performed more than 5% of the deceased donor kidney or liver transplants in NC/NR or whose waitlist registrants exceeded 5% NC/NR. This report was prepared to fulfill the transparency policy of UNOS to assure a public trust in the distribution of organs. When viewed with a public awareness of deceased donor organ shortages, it suggests the need for a more comprehensive understanding of current NC/NR activity in the United States. Patterns of organ specific NC/NR registrations and transplantations at high-volume centers should prompt a review of transplant center practices to determine whether the deceased donor and center resources may be compromised for their US patients.

BackgroundInconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals.MethodsIn a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically.ResultsOne thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, ≥7.5; median, ≥8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps.ConclusionsGraft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.

BackgroundTreatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities.MethodsWe convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation.ResultsSeven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders-inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations.ConclusionsStakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.

The application of advanced biopreservation to organs donated for transplantation may make possible their indefinite storage and thereby improve the utility and equity they provide to patients. The technology is still at a preclinical stage, with many difficult, scientific issues that remain to be answered. At the moment, however, the actual capabilities of the technology are too indefinite to begin formulating the statutes, regulations, and ethical guidance that will be needed to obtain the benefits expected from its use. [ABSTRACT FROM AUTHOR]

Advanced biopreservation technologies using subzero approaches such as supercooling, partial freezing, and vitrification with reanimating techniques including nanoparticle infusion and laser rewarming are rapidly emerging as technologies with potential to radically disrupt biomedicine, research, aquaculture, and conservation. These technologies could pause biological time and facilitate large-scale banking of biomedical products including organs, tissues, and cell therapies. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the author discusses articles within the issue on topics including challenges of advanced biopreservation, biomedical applications, and applications in conservation biology and the food supply such as cryopreservation.

This article presents a framework of ethical analysis for anticipatory evaluation of advanced biopreservation technologies and employs the framework illustratively in three domains. The framework features four clusters of general ethical considerations: (1) Producing Benefits, Minimizing Harms, Balancing Benefits, Risk, and Costs; (2) Justice, Fairness, Equity; (3) Respect for Autonomy; and (4) Transparency, Trustworthiness, and Public Trust. [ABSTRACT FROM AUTHOR]

Research on advanced biopreservation — technologies that include, for example, partial freezing, supercooling, and vitrification with nanoparticle infusion and laser rewarming — is proceeding at a rapid pace, potentially affecting many areas of medicine and the life sciences, food, agriculture, and environmental conservation. Given the breadth and depth of its medical, scientific, and corresponding social impacts, advanced biopreservation is poised to emerge as a disruptive technology with real benefits, but also ethical challenges and risks. Early engagement with potentially affected groups can help navigate possible societal barriers to adoption of this new technology and help ensure that emerging capabilities align with the needs, desires, and expectations of a broad range of interested parties. [ABSTRACT FROM AUTHOR]

ObjectivesApproximately two thirds of patients will remain on insulin therapy after total pancreatectomy with islet autotransplant (TPIAT) for chronic pancreatitis. We investigated the relationship between measured pancreas volume on computerized tomography or magnetic resonance imaging and features of chronic pancreatitis on imaging, with subsequent islet isolation and diabetes outcomes.MethodsComputerized tomography or magnetic resonance imaging was reviewed for pancreas volume (Vitrea software) and presence or absence of calcifications, atrophy, and dilated pancreatic duct in 97 patients undergoing TPIAT. Relationship between these features and (1) islet mass isolated and (2) diabetes status at 1-year post-TPIAT were evaluated.ResultsPancreas volume correlated with islet mass measured as total islet equivalents (r = 0.50, P < 0.0001). Mean islet equivalents were reduced by more than half if any one of calcifications, atrophy, or ductal dilatation were observed. Pancreatic calcifications increased the odds of insulin dependence 4.0 fold (1.1, 15). Collectively, the pancreas volume and 3 imaging features strongly associated with 1-year insulin use (P = 0.07), islet graft failure (P = 0.003), hemoglobin A1c (P = 0.0004), fasting glucose (P = 0.027), and fasting C-peptide level (P = 0.008).ConclusionsMeasures of pancreatic parenchymal destruction on imaging, including smaller pancreas volume and calcifications, associate strongly with impaired islet mass and 1-year diabetes outcomes.