cePolyTregs in Islet Transplantation
Summary
The transplant of the insulin-producing cell into the liver (Islet transplant) has been proven an effective and valuable treatment for type 1 diabetics patients with poor blood sugar. However, Islet transplant is currently limited by the number of pancreas organ donors and the need for lifelong medication requirements such as antirejection drugs. The investigators have learned that Regulatory T cells (Tregs), a small subset of a cluster of differentiation 4+ (CD4+) T cells, have emerged as the major contributor to self-tolerance by preventing the initiation of unwanted immune activation and by suppressing ongoing immune responses to limit bystander tissue destruction. It has been suggested that infusion of Tregs before extensive graft damage may improve long-term graft outcomes. In this trial, we propose to study Analogous cryopreserved PolyTregs (cePolyTregs). cePolyTregs is a product with the same in vivo functionality to that of the non-cryopreserved PolyTregs.
Timeline
- Start
- 2022-08-15
- Primary completion
- 2025-05-22
- Completion
- 2025-05-22
Outcome
Outcome not reported
Stopped: “Due to feasibility challenges and following mutual agreement by JDRF CCTN and the Principal Investigator for Statement of Work 4 (SOW4), the study conducted by Dr. James Shapiro has been withdrawn/terminated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cePolytreg | Cell therapy | 1e+08 cells | Intravenous |
| Subject | cePolytreg | Cell therapy | 4e+08 cells | Intravenous |
| Subject | cePolytreg | Cell therapy | 1.6e+09 cells | Intravenous |