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Clinical Islet Transplantation With Apheresis, Isolation and Reintroduction of Recipient Regulatory T Cells or Administration of Deceased Donor Vertebral Bone Marrow in Type 1 Diabetes
The goal of this clinical trial is to learn if patients who have brittle type 1 diabetes receiving an islet transplantation will have better control of their sugars if they also receive one of 2 types of immune cells along with the islet transplant. The participants will receive either their own immune cells, called regulatory T cells, or immune cells from the bone marrow of the islet donor.
Details
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 1 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 24 |
| Start date | 2023-10-01 |
| Completion | 2028-05 |
Conditions
- Islet Transplantation
Interventions
- Infusion of recipient T regulatory cell
- Infusion of concomitant Donor Derived Vertebral Bone Marrow
Primary outcomes
- Occurrence of Grade 3 to 5 cytokine release syndrome / acute infusion reaction after Treg administration infusion reaction after Treg administration — within 3 months
Grade 3 to 5 cytokine release syndrome / acute infusion reaction after Treg administration infusion reaction after Treg administration - Occurrence of grade 4 or greater adverse events of islet transplantation — Within two years
Adverse event grade 4 or greater - Number of patients who receive Treg infusions (Arm1) or Donor Derived Vertebral Bone Marrow (Arm2) and islet transplantation (feasibility) — Within two years
Number of patients who received planned Treg or Donor Bone Marrow
Countries
United States