A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus

An Open-Label Phase 1/2 Study to Evaluate the Safety, Engraftment, and Efficacy of VC-01™Combination Product in Subjects With Type 1 Diabetes Mellitus [T1DM]

VC01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.

This trial will test if VC-01 combination product can be implanted and maintained with safety, tolerability, and efficacy for up to Month 12/Week 52.

Inclusion Criteria:

• Men and non-pregnant women
• Diagnosis of T1DM for a minimum of 3 years.
• Stable, optimized diabetic regimen
• Acceptable candidate for implant and explant procedures.
• Willing and able to comply with protocol requirements.
• Meet insulin dosing requirements per protocol

Exclusion Criteria:

• Advanced complications associated with diabetes