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NCT02239354 Clinical Trial

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

Type 1 Diabetes Mellitus Clinical Trial

Official title:
A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02239354
Other study ID # VC01-101
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date September 2014
Est. completion date December 2017

Study information
Verified date February 2022
Source ViaCyte
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 19
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• VC-01™ Combination Product
Biologic and Device

Locations
Country Name City State
Canada University of Alberta Hospital Edmonton Alberta
United States University of California at San Diego San Diego California

Sponsors (2)
Lead Sponsor Collaborator
ViaCyte California Institute for Regenerative Medicine (CIRM)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Adverse Events Reported During the Study. Thru the Month 24 Visit
Primary Change in C-peptide The Full Analysis Set (FAS) is the intent-to-treat (ITT) set of subjects. This set is defined as all T1DM subjects who were enrolled into the study and received implantation of at least one VC-01-250 or sentinel unit on Study Day 1. The FAS (Cohort 2 T1DM subjects who meet the FAS criteria) will be used to analyze the primary efficacy endpoint. Baseline to the Month 6 Visit
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