Trials / Completed
CompletedNCT05210530
An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1D
An Open-Label, First-In-Human Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With Type 1 Diabetes Mellitus (T1D)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- CRISPR Therapeutics AG · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter, Phase 1 study evaluating the safety and tolerability of VCTX210A combination product in patients with T1D
Detailed description
VCTX210A combination product (unit) comprises 2 components: (1) allogeneic pancreatic endoderm cells (PEC210A) genetically modified using Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein 9 (CRISPR/Cas9) to promote immune evasiveness and survival, and (2) a durable, removable, perforated device designed to deliver and retain the PEC210A cells.
Conditions
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Glucose Metabolism Disorders
- Metabolic Disease
- Endocrine System Diseases
- Autoimmune Diseases
- Immune System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | VCTX210A unit | CRISPR-Cas9 genetically modified PEC210A cells loaded into a delivery device |
Timeline
- Start date
- 2022-01-24
- Primary completion
- 2023-01-19
- Completion
- 2023-01-19
- First posted
- 2022-01-27
- Last updated
- 2023-06-26
Locations
3 sites across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05210530. Inclusion in this directory is not an endorsement.