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Islet Transplantation in Type I Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
A Phase 3 clinical trial has been completed and demonstrated the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol.The objective in offering expanded access to donislecel (allogeneic islets of Langerhans for transplant; IND BB-11807) for the treatment of brittle T1D is to bridge the gap between completed clinical trials and marketing (i.e. approval by the FDA of a biological license application). Expanded access will allow clinical trial subjects, as well as patients outside a clinical trial, to receive treatment. New patients participating in the expanded access protocol are required to meet exclusion and inclusion criteria.
Details
| Lead sponsor | CellTrans Inc. |
|---|---|
| Status | APPROVED_FOR_MARKETING |
Conditions
- Type 1 Diabetes Mellitus
Interventions
- Donislecel (allogeneic islets of Langerhans for transplant)
Countries
United States