A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
- Conditions
- Type 1 Diabetes Mellitus With Hypoglycemia
- Registration Number
- NCT03163511
- Lead Sponsor
- ViaCyte
- Brief Summary
VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.
- Detailed Description
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- Men and non-pregnant women
- Diagnosis of T1DM for a minimum of five (5) years
- Hypoglycemia unawareness or significant glycemic lability
- Stable diabetic treatment
- Willingness to use a continuous glucose meter
- Acceptable candidate for implantation
- History of islet cell, kidney, and/or pancreas transplant.
- Six (6) 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
- Detectable stimulated serum C-peptide during screening period assessment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Incidence of All AEs in Cohort 1 Participants Enrollment (Visit 3, Day 1) through the Month 4 Visit Incidence of all AEs and evaluation of causality related to VC-02 combination product, the surgical procedures, and the immunosuppressive drug regimen.
Change in C-peptide for Cohort 2 Subjects Baseline to Week 26 Visit Change from baseline to Week 26 in C-peptide area under the curve from 0 to 4 hours following a mixed meal tolerance test.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
City of Hope National Medical Center
🇺🇸Duarte, California, United States
UCLA-UCI Alpha Stem Cell Clinic
🇺🇸Irvine, California, United States
UC Davis - Alpha Stem Cell Clinic
🇺🇸Sacramento, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University Hospital Brussels
🇧🇪Brussel, Belgium
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
City of Hope National Medical Center🇺🇸Duarte, California, United States