Islet Transplantation in Type I Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

Summary

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.

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Publications

• Background Qi M, Kinzer K, Danielson KK, Martellotto J, Barbaro B, Wang Y, Bui JT, Gaba RC, Knuttinen G, Garcia-Roca R, Tzvetanov I, Heitman A, Davis M, McGarrigle JJ, Benedetti E, Oberholzer J. Five-year follow-up of patients with type 1 diabetes transplanted with allogeneic islets: the UIC experience. Acta Diabetol. 2014 Oct;51(5):833-43. doi: 10.1007/s00592-014-0627-6. Epub 2014 Jul 18.
• Background Williams J, Jacus N, Kavalackal K, Danielson KK, Monson RS, Wang Y, Oberholzer J. Over ten-year insulin independence following single allogeneic islet transplant without T-cell depleting antibody induction. Islets. 2018;10(4):168-174. doi: 10.1080/19382014.2018.1451281. Epub 2018 Jul 19.

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