Diabetes Free, Inc.

The goal of this phase 1, first-in-human, interventional study is to test if the therapy can allow for successful islet transplantation from an unrelated donor without the use of long-term immunosuppression (or induce tolerance to islets). The study will examine results of six islet transplants performed in patients with a specific form of insulin-dependent type 2 diabetes. The main questions it aims to answer are:
Is the tolerance inducing therapy safe; and
Can the tolerance inducing therapy allow for the transplanted islets to survive and produce insulin without the use of the long-term immunosuppression commonly used after islet transplant.
Participants will be asked to undergo islet transplant and repeat metabolic testing (requires hospitalization), track their blood glucose with a study provided continuous glucose monitor, and self-administer some of the therapy drugs. Over 75 days, treatments given in addition to standard of care for islet transplant (only if a suitable transplant donor is identified) are:
An experimental cell therapy made from the donor's spleen (ToleraCell) An experimental antibody (DFI-105) Three other drugs that have been previously used in islet transplantation (sirolimus, etanercept, tocilizumab) Researchers will track your blood glucose, metabolic status, and insulin use over one year post-transplant and follow your overall health status for 5 years.