Trials / Recruiting
RecruitingNCT05647213
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
Safety and Feasibility of Autologous Induced Pluripotent Stem Cells of Cardiac Lineage in Subjects With Congenital Heart Disease
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- HeartWorks, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are: * Is this product safe to deliver to humans * Is the conduct of this trial feasible Participants will be asked to: * Agree to testing and monitoring before and after product administration * Receive investigational product * Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | iPSC-CL | Autologous IPSCL |
Timeline
- Start date
- 2023-02-03
- Primary completion
- 2027-09-01
- Completion
- 2029-02-01
- First posted
- 2022-12-12
- Last updated
- 2026-03-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05647213. Inclusion in this directory is not an endorsement.