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Why Pancreatic Islets Should Be Regarded and Regulated Like Organs

Overview
Journal CellR4 Repair Replace Regen Reprogram
Date 2021 Mar 31
PMID 33786336
Citations 3
Authors
G C Weir
S Bonner-Weir
Affiliations
Soon will be listed here.
Abstract

There are strong reasons to say that pancreatic islets are organs before they are isolated and that they should be considered to be organs once transplanted. Thus, taking into account how much we have learned about the structure and function of islet micro-organs, it seems highly illogical to on one hand consider autologous islets be regulated as organ transplants and alloislets to be regulated with the very restrictive rules used for cell transplantation. It is particularly problematic that this policy has led to restrictions that have made it next to impossible for transplants of alloislets to be carried out in the US, which is a very sad situation for the country that made so many of the advances that brought islet transplantation to the clinic.

Citing Articles

Demise of cadaveric islet transplantation in the USA: Quo Vadis, 1 year after BLA approval and 24 years after the Edmonton breakthrough?.

Witkowski P, Wojcik N, Appelbaum N, Fung J, Barth R, Ricordi C Front Transplant. 2025; 4:1491568.

PMID: 39949592 PMC: 11822476. DOI: 10.3389/frtra.2025.1491568.

Benefits and Hurdles of Pancreatic β-Cell Replacement.

Bolla A, Montefusco L, Pastore I, Lunati M, Ben Nasr M, Fiorina P Stem Cells Transl Med. 2022; 11(10):1029-1039.

PMID: 36073717 PMC: 9585952. DOI: 10.1093/stcltm/szac058.

Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress.

Witkowski P, Philipson L, Buse J, Robertson R, Alejandro R, Bellin M Front Endocrinol (Lausanne). 2022; 12:789526.

PMID: 35069442 PMC: 8772267. DOI: 10.3389/fendo.2021.789526.

Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting.

Witkowski P, Odorico J, Pyda J, Anteby R, Stratta R, Schrope B J Clin Med. 2021; 10(13).

PMID: 34209541 PMC: 8269003. DOI: 10.3390/jcm10132878.

References
1.
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