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
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2022
• Source: ViaCyte
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

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