organ procurement
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Author(s):  
Kristen L King ◽  
S Ali Husain ◽  
Adler Perotte ◽  
Joel T. Adler ◽  
Jesse D Schold ◽  
...  

2022 ◽  
Vol 12 ◽  
Author(s):  
Piotr Witkowski ◽  
Louis H. Philipson ◽  
John B. Buse ◽  
R. Paul Robertson ◽  
Rodolfo Alejandro ◽  
...  

Clinical islet allotransplantation has been successfully regulated as tissue/organ for transplantation in number of countries and is recognized as a safe and efficacious therapy for selected patients with type 1 diabetes mellitus. However, in the United States, the FDA considers pancreatic islets as a biologic drug, and islet transplantation has not yet shifted from the experimental to the clinical arena for last 20 years. In order to transplant islets, the FDA requires a valid Biological License Application (BLA) in place. The BLA process is costly and lengthy. However, despite the application of drug manufacturing technology and regulations, the final islet product sterility and potency cannot be confirmed, even when islets meet all the predetermined release criteria. Therefore, further regulation of islets as drugs is obsolete and will continue to hinder clinical application of islet transplantation in the US. The Organ Procurement and Transplantation Network together with the United Network for Organ Sharing have developed separately from the FDA and BLA regulatory framework for human organs under the Human Resources & Services Administration to assure safety and efficacy of transplantation. Based on similar biologic characteristics of islets and human organs, we propose inclusion of islets into the existing regulatory framework for organs for transplantation, along with continued FDA oversight for islet processing, as it is for other cell/tissue products exempt from BLA. This approach would reassure islet quality, efficacy and access for Americans with diabetes to this effective procedure.


Author(s):  
Hiroaki Mitsugashira ◽  
Kazuaki Tokodai ◽  
Wataru Nakanishi ◽  
Atsushi Fujio ◽  
Toshiaki Kashiwadate ◽  
...  
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2021 ◽  
pp. 261-284
Author(s):  
Lainie Friedman ◽  
J. Richard Thistlethwaite, Jr

As the supply-demand gap for organs for transplantation grows, transplant programs are more accepting of less healthy donors. This chapter focuses on the extreme case: whether and when individuals who have life-limiting conditions (LLC) should be considered for living organ donation. Two types of cases are examined: living donation by individuals with advanced progressive severe debilitating disease for whom there is no ameliorative therapy; and pre-mortem living donation by individuals who are imminently dying or would die of the donation process itself. With appropriate safeguards, some donations by individuals with LLC could be ethical. Pre-mortem donations challenge the dead donor rule (DDR), an ethical norm that prohibits organ procurement until after the individual is dead. The chapter argues that attempts to circumvent the DDR fail to respect the living donor as a patient in his or her own right.


Author(s):  
Lainie Friedman Ross ◽  
J. Richard Thistlethwaite, Jr.

This is a book about living solid organ donors as patients in their own right. This book is premised on the supposition that the field of living donor organ transplantation is ethical, even if some specific applications are not, eg, pre-mortem organ procurement of an imminently dying patient. When Joseph Murray performed the first successful living kidney donor transplant in 1954, he thought this would be a temporary stopgap. Today, however, the goal of adequate organ supply without living donors remains elusive. If anything, the supply:demand ratio is worse. In this book, a five-principle living donor ethics framework is developed and used to examine the ethical issues raised by living donor selection demographics, innovative attempts to increase living organ donation, and living donor decision-making and risk thresholds. This ethics framework uses the three principles of the Belmont Report modified to organ transplantation (respect for persons, beneficence, and justice) supplemented by the principles of vulnerability and of special relationships creating special obligations. The approach requires that the transplant community fully embraces living organ donors (and prospective living organ donors) as patients to whom special obligations are owed. Only when living organ donors are regarded as patients in their own right and have a living donor advocate team dedicated to their well-being can the moral boundaries of living solid organ donation be determined and realized. This book provides theoretical arguments and practice guidelines, complemented by case studies, to ensure that living donors are given the full respect and care they deserve.


2021 ◽  
pp. 3-21
Author(s):  
Lainie Friedman ◽  
J. Richard Thistlethwaite, Jr

This is a book about living solid organ donors as patients in their own right. It is premised on the supposition that the field of living donor organ transplantation is ethical, even if some instantiations are not, eg, pre-mortem organ procurement of an imminently dying patient. In this chapter, the objection to living solid organ donation based on the obligation to do no harm is rejected because it ignores the fact that for many living donors, the benefits outweigh the harms. It is argued that the principle of respect for persons permits some living solid organ donation provided that both the donor and the recipient are treated as patients in their own right. This chapter then provides an outline for the rest of the book in which a five-principle living donor ethics framework is developed and applied to various living donor transplant proposals.


2021 ◽  
pp. 369-378
Author(s):  
Lainie Friedman ◽  
J. Richard Thistlethwaite, Jr

Given the gap between demand and supply, living donation is not going away any time soon. This chapter explores the book’s initial premise that the field of living donor organ transplantation is ethical, even if some specific applications are not, eg pre-mortem organ procurement of an imminently dying patient. Concerns regarding the appropriate moral limits to living solid organ donation by both eminent transplant physicians (Joseph Murray, Felix Rapaport) and the social scientists (Renée Fox, Judith Swazey) embedded in evaluating the practice are explored. This chapter reiterates the book’s primary position: only if living organ donors are regarded as patients in their own right can the moral limits of living solid organ donation be realized and living donors be given the full respect that they deserve.


2021 ◽  
Vol 11 (12) ◽  
pp. 1383
Author(s):  
Arian Hosseinzadeh ◽  
Mehdi Najafi ◽  
Wisit Cheungpasitporn ◽  
Charat Thongprayoon ◽  
Mahdi Fathi

In United States (U.S.), government-funded organizations, such as NLDAC, reimburse travel and subsistence expenses incurred during living-organ donation process. However, in Iran, there is a non-governmental organization called Iranian Kidney Foundation (IKF) that funds the direct and indirect costs of donors through charitable donations and contributions from participants in the exchange program. In this article, for countries outside the U.S. that currently use an equality approach, we propose a potential new compensation-apportionment approach (equitable approach) for kidney-exchange chains and compare it with the currently available system (equality approach) in terms of the apportionment of compensation in a kidney-exchange chain to cover the expenses incurred by the initiating living donor of the chain in the act of donation. To this end, we propose a mechanism to apportion compensation among all participating pairs based on the equity approach by utilizing a prediction model to calculate the probability of graft survival in each transplant operation. These probabilities are then used to define the utility of any transplantation, considering the quality of each pair’s donated and received kidney in the chain. Afterward, the corresponding cost is apportioned by a mechanism based on the normalized differences between the utility of donated and received kidneys for each incompatible pair of the chain. In summary, we demonstrate that by utilizing the equitable approach, there is more fairness and equity in the allocation of resources in organ-procurement systems, which results in more satisfaction among incompatible pairs. Additional future prospective studies are needed to assess this proposed equitable approach for kidney-exchange chains in countries outside the U.S., such as Iran, that currently use an equality approach.


2021 ◽  
Vol 50 (1) ◽  
pp. 261-261
Author(s):  
Nina Fainberg ◽  
Wynne Morrison ◽  
Sharon West ◽  
Richard Hasz ◽  
Matthew Kirschen

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