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

Completed · Phase 1/Phase 2

Conditions studied: Type 1 Diabetes Mellitus With Hypoglycemia

In brief

VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.

Key facts

Study ID

NCT03163511

Run by

ViaCyte

People needed

49

Starts

2017-07-06

Expected to finish

2023-10-19

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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 — Brussels, Belgium
• University of Alberta — Edmonton, Alberta, Canada
• University of British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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