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

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

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...

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Bibliographic Details
Main Authors: Alejandro, R. (Author), Al-Salmay, Y. (Author), Anteby, R. (Author), Bachul, P.J (Author), Baidal, D. (Author), Barth, R.N (Author), Bellin, M.D (Author), Buse, J.B (Author), Fung, J.J (Author), Gaglia, J.L (Author), Jayant, K. (Author), Kandeel, F. (Author), Perez-Gutierrez, A. (Author), Philipson, L.H (Author), Posselt, A.M (Author), Ricordi, C. (Author), Robertson, R.P (Author), the “Islets for US Collaborative“ (Author), Witkowski, P. (Author)
Format: Article
Language:English
Published: Frontiers Media S.A. 2022
Subjects:
Article
biological license application
clinical outcome
drug sterility
Food and Drug Administration
Food and Drug Administration (FDA)
human
insulin dependent diabetes mellitus
international health regulation
islets transplantation
pancreas donor
pancreas islet cell
pancreas islet transplantation
patient safety
protocol compliance
quality control
regulations and policy
treatment outcome
type 1 diabetes mellitus
United States
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