A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus

ViaCyte

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Combination Product: VC-01™ Combination Product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02239354

VC01-101

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Cohort 1

Experimental group

Description:

2 VC-01™ Combination Product implants

Treatment:

Combination Product: VC-01™ Combination Product

Cohort 2

Experimental group

Description:

4 or 6 VC-01™ Combination Product implants

Treatment:

Combination Product: VC-01™ Combination Product