A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
An Outline of This Clinical Trial
This is a research study testing a possible new treatment for Type 1 diabetes called VC-01TM combination product. The product consists of two parts: pancreatic endoderm cells (from human embryonic stem cells), called PEC-01™ cells, and a retrievable encapsulation device known as the Encaptra drug delivery system. VC-01TM is expected to control blood glucose as a “replacement pancreas” producing insulin after it is surgically placed under the skin. It is estimated this may take several months to work. Insulin doses will continue to be used as prescribed. Study staff will monitor each participant's diabetes, blood sugar values, and any hypoglycemia (low blood sugar) throughout study participation and adjust insulin doses when needed.
Participants will be assigned to receive a select number of VC-01TM units implanted during the study. Smaller VC-01TM units will be removed at various points in the study, but the larger units will not be removed until the end of the study. This study will last approximately 2 years and includes about 19 visits to the study clinic (including initial screening visits).
To be eligible for this study, participants must be an adult (between the ages of 18 and 55 years old), have been diagnosed with Type 1 diabetes for a minimum of 3 years, and have a stable, optimized diabetic regimen for at least 3 months.