Transplanting islet cells can fix brittle diabetes.
Why isn’t it available in the U.S.?
Dr. Camilo Ricordi points out regulatory barriers introduced by FDA, which leads to the extinction of islet transplantation in the US, while the rest of the world benefits from islet trials funded by US tax payers, due to less restrictive regulations.
Sept 3rd, 2018
Meeting of the CIT Consortium leaders with FDA regarding re-classification of human islets.
Leaders proposed human cadaveric islet re-classinfication from biologics to minimally manipulated tissue based on over 15 year studies proving stability of islets during 72 hour incubation prior to transplantation.
FDA rejected the request.
As a result, islets are still regulated as biologic drug, which precludes further clinical use of islets beyond clinical trials.
Based on less restrictive regulation other countries already introduced islet transplantation as a standard of care.