Insufficient functional product engraftment

The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.

Inclusion Criteria:

• Men and women (non-pregnant and non-childbearing potential)
• Diagnosis of type 1 diabetes mellitus for at least 3 years
• Stable diabetic treatment
• Willingness to use a continuous glucose meter
• Acceptable candidate for implantation

Exclusion Criteria:

• Advanced complications associated with diabetes
• Immunosuppressive therapy

Cohort 2 enrollment was never initiated and is therefore 'zero'.

AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.

All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,

Study did not proceed to Cohort 2 to evaluate efficacy.