This is an Investigator Initiated, Phase I/II study, where Type 1 diabetic participants will
receive a 14 day oral treatment of the investigational caspase inhibitor drug IDN-6556
following their first islet transplant. Two pilot studies are proposed to establish the
optimal safety and efficacy dose of IDN-6556 (25 mg twice daily (Pilot 1) or a loading dose
of 100 mg two hours prior to transplantation, then two 50 mg doses following transplant (Day
0) (Pilot 2). This will be followed by 50 mg three times daily). Participants of both pilot
studies will receive islet cell transplants under the University of Alberta's
standard-of-care therapy.
Secondary objectives include:
1. To determine the proportion of subjects treated with IDN-6556 who achieve and maintain
insulin independence after the first or subsequent islet transplant.
2. To obtain preliminary data on the efficacy of IDN-6556 to maintain adequate
immunological protection against both allo- and autoimmunity of islet transplant
recipients.