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

Type 1 Diabetes Mellitus With Hypoglycemia Clinical Trial

Official title:

An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163511
• Other study ID #: VC02-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 6, 2017
• Est. completion date: October 19, 2023

Study information

• Verified date: November 2023
• Source: ViaCyte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 19, 2023
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus With Hypoglycemia

Intervention

Combination Product:
• VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device

Locations

Country	Name	City	State
Belgium	University Hospital Brussels	Brussel
Canada	University of Alberta	Edmonton	Alberta
Canada	University of British Columbia	Vancouver	British Columbia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Ohio State University	Columbus	Ohio
United States	City of Hope National Medical Center	Duarte	California
United States	UCLA-UCI Alpha Stem Cell Clinic	Irvine	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	UC Davis - Alpha Stem Cell Clinic	Sacramento	California
United States	University of California San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
ViaCyte	California Institute for Regenerative Medicine (CIRM), Horizon 2020 - European Commission

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all adverse events reported for Cohort 1 subjects	AEs through four months.	Thru the Month 4 Visit
Primary	Change in C-peptide for Cohort 2 subjects	Change in C-peptide from baseline.	Baseline to the Month 6 Visit