A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT02239354 |
Recruitment Status :
Terminated
(Insufficient functional product engraftment)
First Posted : September 12, 2014
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Combination Product: VC-01™ Combination Product | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | September 2014 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
2 VC-01™ Combination Product implants
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Combination Product: VC-01™ Combination Product
Biologic and Device |
Experimental: Cohort 2
4 or 6 VC-01™ Combination Product implants
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Combination Product: VC-01™ Combination Product
Biologic and Device |
- Number of Adverse Events Reported During the Study. [ Time Frame: Thru the Month 24 Visit ]
- Change in C-peptide [ Time Frame: Baseline to the Month 6 Visit ]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.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239354
United States, California | |
University of California at San Diego | |
San Diego, California, United States | |
Canada, Alberta | |
University of Alberta Hospital | |
Edmonton, Alberta, Canada, T6G 2B7 |
Responsible Party: | ViaCyte |
ClinicalTrials.gov Identifier: | NCT02239354 |
Other Study ID Numbers: |
VC01-101 |
First Posted: | September 12, 2014 Key Record Dates |
Results First Posted: | March 24, 2022 |
Last Update Posted: | March 24, 2022 |
Last Verified: | February 2022 |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |