Trials / Completed
CompletedNCT03163511
A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- ViaCyte · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | VC-02 Combination Product | PEC-01 cells loaded into a Delivery Device |
Timeline
- Start date
- 2017-07-06
- Primary completion
- 2023-10-13
- Completion
- 2023-10-19
- First posted
- 2017-05-23
- Last updated
- 2024-12-03
- Results posted
- 2024-12-03
Locations
10 sites across 3 countries: United States, Belgium, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03163511. Inclusion in this directory is not an endorsement.