Article ; Online: The demise of islet allotransplantation in the United States: A call for an urgent regulatory update.
2021 Volume 21, Issue 4, Page(s) 1365–1375
Abstract: Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the- ...
Abstract | Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and "more than minimally manipulated" human cell and tissue products (HCT/Ps). In contrast, across the world, human islets are appropriately defined as "minimally manipulated tissue" and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States. |
|||||
---|---|---|---|---|---|---|
MeSH term(s) | Biological Products ; Costs and Cost Analysis ; Diabetes Mellitus, Type 1/surgery ; Humans ; Islets of Langerhans Transplantation ; Transplantation, Heterologous ; United States | |||||
Chemical Substances | Biological Products | |||||
Language | English | |||||
Publishing date | 2021-02-10 | |||||
Publishing country | United States | |||||
Document type | Journal Article ; Research Support, N.I.H., Extramural | |||||
ZDB-ID | 2060594-8 | |||||
ISSN | 1600-6143 ; 1600-6135 | |||||
ISSN (online) | 1600-6143 | |||||
ISSN | 1600-6135 | |||||
DOI | 10.1111/ajt.16397 | |||||
Shelf mark |
|
|||||
Database | MEDical Literature Analysis and Retrieval System OnLINE |
Full text online
More links
Kategorien
In stock of ZB MED Cologne/Königswinter
Zs.A 5542: Show issues | Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG) |
Order via subito
This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.