Safety and Efficacy of PEG-Encapsulated Islet Allografts Implanted in Type I Diabetic Recipients
Summary
Insulin dependent Type I diabetics require daily insulin therapy to normalize blood glucose but may have difficulty with significant glycemic excursions and hypoglycemic episodes and crises. Islet cell transplantation can provide relief from daily insulin therapy, normalize blood glucose and reduce or eliminate short and long-term diabetes-related complications. "PEG-Encapsulated Islet Allografts" is a new islet transplant product under development that does not require the ongoing use of immunosuppressive drugs after the implant. This study will test the safety and efficacy of PEG-Encapsulated Islet Allografts in the treatment of Type I diabetes and provide functional outcome measurements.
Timeline
- Start
- 2005-11
- Primary completion
- 2007-12
- Completion
- 2007-12
Outcome
Outcome not reported
Stopped: “Stopped in December 2007”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic Cultured Islet Cells (human); Encapsulated | Unknown | — | Subcutaneous |