A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus (VC01-103)

ViaCyte

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Type 1 Diabetes

Treatments: Combination Product: VC-01 Combination Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT04678557

VC01-103

Details and patient eligibility

About

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

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Sentinel units (aka Cohort 1)

Experimental group

Description:

VC-01 Combination Product; Up to ten (10) VC-01 sentinels

Treatment:

Combination Product: VC-01 Combination Product

Dose-finding units (aka Cohort 2)

Experimental group

Description:

VC-01 Combination Product; Up to twelve units implanted of which up to nine (9) are VC-01-DF (dose-finding) implants and the rest are VC-01 sentinels

Treatment:

Combination Product: VC-01 Combination Product