A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

ViaCyte

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Combination Product: VC-02 Combination Product (aka PEC-Direct)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03162926

VC02-102

Details and patient eligibility

About

The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and non-pregnant women of non-childbearing potential
• Diagnosis of T1DM for a minimum of five (5) years
• Stable diabetic treatment
• Willingness to use a continuous glucose meter
• Acceptable candidate for implantation

Exclusion criteria

• History of islet cell, kidney, and/or pancreas transplant.
• Two (2) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
• Uncontrolled or untreated thyroid disease or adrenal insufficiency
• Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
• Non-compliance with current anti-diabetic regimen

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Single-group

Experimental group

Description:

Up to six (6) VC-02-20 implants

Treatment:

Combination Product: VC-02 Combination Product (aka PEC-Direct)