drugset / Trial / NCT00260234

Safety and Efficacy of PEG-Encapsulated Islet Allografts Implanted in Type I Diabetic Recipients

NCT00260234 ↗

Non-randomizedSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
Subject Allogeneic Cultured Islet Cells (human); Encapsulated Unknown — Subcutaneous