Status:
NOT_YET_RECRUITING
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG
Lead Sponsor:
Rohto Pharmaceutical Co., Ltd.
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ische...
Eligibility Criteria
Inclusion
- Patients clinically diagnosed with chronic heart failure due to ischemic heart disease who undergo CABG
- Patients with an LVEF of less than 40% as determined by the cardiac ultrasound at the screening examination.
- Others
Exclusion
- Patients who have a combination of cardiovascular disease such as severe organic valvular disease.
- Patients who have developed acute coronary syndrome within 3 months prior to obtaining consent.
- Others
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07192211
Start Date
September 1 2025
End Date
March 31 2029
Last Update
September 25 2025
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