Trials / Terminated
TerminatedNCT04678557
A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus
An Open-Label Phase 1/2 Study to Evaluate the Safety, Engraftment, and Efficacy of VC-01™Combination Product in Subjects With Type 1 Diabetes Mellitus [T1DM]
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- ViaCyte · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
VC01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.
Detailed description
This trial will test if VC-01 combination product can be implanted and maintained with safety, tolerability, and efficacy for up to Month 12/Week 52.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | VC-01 Combination Product | PEC-01 cells loaded into an Encaptra Drug Delivery System |
Timeline
- Start date
- 2019-06-25
- Primary completion
- 2021-11-12
- Completion
- 2021-11-19
- First posted
- 2020-12-22
- Last updated
- 2023-10-18
- Results posted
- 2023-10-18
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04678557. Inclusion in this directory is not an endorsement.