Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression

• Status: Active, not recruiting
• Trial end date: 2023-05-01

Summary

SPECIFIC AIMS:

1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation;

2. To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation;

3. To assess long-term safety and function of successful islet cell transplants in patients with Type 1 Diabetes Mellitus;

4. To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells; and

5. To assess the effect of infliximab in preventing early islet destruction, and thereby eliminating the need for a second donor's islet cells.

6. To assess the effect of etanercept in preventing early islet destruction.

7. To assess the effect of exenatide to improve islet graft function and survival in subjects that have returned to using exogenous insulin.

8. To assess the ability of exenatide to improve islet survival at time of transplantation.

• Phase: Phase 2

Details

• Lead Sponsor: Rodolfo Alejandro
• Collaborators: Diabetes Research Institute Foundation; Health Resources and Services Administration (HRSA); National Institutes of Health (NIH)