Back to resultsA Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VC-01™ Combination Product
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- University of California at San Diego
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
2 VC-01™ Combination Product implants
4 or 6 VC-01™ Combination Product implants
Outcomes
Primary Outcome Measures
Number of Adverse Events Reported During the Study.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02239354
First Posted
September 9, 2014
Last Updated
February 25, 2022
Sponsor
ViaCyte
Collaborators
California Institute for Regenerative Medicine (CIRM)
1. Study Identification
Unique Protocol Identification Number
NCT02239354
Brief Title
A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient functional product engraftment
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViaCyte
Collaborators
California Institute for Regenerative Medicine (CIRM)
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
2 VC-01™ Combination Product implants
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
4 or 6 VC-01™ Combination Product implants
Intervention Type
Combination Product
Intervention Name(s)
VC-01™ Combination Product
Intervention Description
Biologic and Device
Primary Outcome Measure Information:
Title
Number of Adverse Events Reported During the Study.
Time Frame
Thru the Month 24 Visit
Title
Change in C-peptide
Description
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.
Time Frame
Baseline to the Month 6 Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34193595
Citation
Satin LS, Soleimanpour SA, Walker EM. New Aspects of Diabetes Research and Therapeutic Development. Pharmacol Rev. 2021 Jul;73(3):1001-1015. doi: 10.1124/pharmrev.120.000160.
Results Reference
derived
PubMed Identifier
29420708
Citation
Saber N, Bruin JE, O'Dwyer S, Schuster H, Rezania A, Kieffer TJ. Sex Differences in Maturation of Human Embryonic Stem Cell-Derived beta Cells in Mice. Endocrinology. 2018 Apr 1;159(4):1827-1841. doi: 10.1210/en.2018-00048.
Results Reference
derived
PubMed Identifier
29317381
Citation
Pase C, Mathias AD, Garcia CD, Garcia Rodrigues C. Using Social Media for the Promotion of Education and Consultation in Adolescents Who Have Undergone Kidney Transplant: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2018 Jan 9;7(1):e3. doi: 10.2196/resprot.8065.
Results Reference
derived
Learn more about this trial
A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
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