Trials / Not Yet Recruiting
Not Yet RecruitingNCT07192211
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo Coronary Artery Bypass Surgery
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Rohto Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
ADR-002K is administered to heart failure patients with ischemic heart disease who undergo coronary artery bypass surgery (CABG) to investigate its efficacy and safety.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. ADR-002K (Adipose-derived mesenchymal stem cells) is administered to the surface of the heart in patients with ischemic heart disease who undergo CABG. The efficacy and safety of ADR-002K are evaluated until the last patient has completed the 2-year evaluation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Mesenchymal stem cell | ADR-002K administration |
| BIOLOGICAL | Placebo | Placebo |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2028-09-30
- Completion
- 2029-03-31
- First posted
- 2025-09-25
- Last updated
- 2025-09-25
Source: ClinicalTrials.gov record NCT07192211. Inclusion in this directory is not an endorsement.