Trials / Unknown
UnknownNCT05566600
Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- HELP Therapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery. After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Human (allogeneic) iPS-cell-derived cardiomyocyte | 10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium |
Timeline
- Start date
- 2022-10-09
- Primary completion
- 2024-12-31
- Completion
- 2025-07-31
- First posted
- 2022-10-04
- Last updated
- 2023-11-22
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05566600. Inclusion in this directory is not an endorsement.