Safety, Tolerability, and Efficacy of VC-02TM Combination Product in Subjects with Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
An Outline of This Clinical Trial
This is a research study testing a possible new treatment for Type 1 diabetes called VC-02TM combination product. VC-02TM is called a combination product because it consists of two parts: pancreatic endoderm cells (from human embryonic stem cells), called PEC-01TM cells, and a delivery device designed to hold the PEC-01TM cells at the implant location. VC-02TM is expected to control blood glucose as a “replacement pancreas” producing insulin after it is surgically placed under the skin.
After VC-02TM is implanted, the PEC-01TM cells are expected to mature over several months and then produce insulin as a pancreas would to control blood glucose levels. In this study, there are two types of VC-02TM units that will be surgically implanted. One is a larger VC-02TM unit, that is roughly half the size of a business card, and the other is a smaller VC-02TM unit, that is about the size of a fingernail. Both products have about the thickness of a credit card.
Participants will also receive immunosuppression medications to help the cells grow and to prevent the body's immune system from rejecting the implanted VC-02TM units.
Prospective participants may be eligible for this study if an adult (between the ages of 18 and 65 years old), have been diagnosed with Type 1 diabetes for a minimum of 5 years, and have a stable, optimized diabetic regimen for at least 3 months.