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Review
. 2025 Jan 30:4:1491568.
doi: 10.3389/frtra.2025.1491568. eCollection 2025.

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

Piotr Witkowski  1 , Nicole Wojcik  1 , Nathan Appelbaum  1 , John J Fung  1 , Rolf N Barth  1 , Camillo Ricordi  2
Affiliations
Review

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

Piotr Witkowski et al. Front Transplant. .

Abstract

More than a year after the Biological License Application (BLA) approval for CellTrans, cadaveric islet transplantation remains in demise in the United States (U.S.). While the therapy is unavailable to Americans, it is already a standard of care procedure in other countries, including Canada, Australia, and many in Europe. This article discusses the challenges stemming from an outdated regulatory framework in the U.S. concerning cadaveric islet transplantation. It also presents advocacy efforts by the transplant community for appropriate regulatory adjustments and discusses future perspectives.

Keywords: Edmonton protocol; Food and Drug Administration; biological license application; demise of islet transplantation; islet transplantation; regulatory update; type 1 diabetes mellitus.

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Conflict of interest statement

PW has served as a consultant to Sernova, Eledon, Vertex, Seraxis, has been a member of the Steering Committee for clinical trials sponsored by Vertex and has an equity interest in Eledon Pharmaceutical and Sana Biotechnology. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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