Heart Failure Clinical Trial
Official title:
EFFICACY AND SAFETY OF BONE MARROW-DERIVED MESENCHYMAL CARDIOPOIETIC CELLS (C3BS-CQR-1) FOR THE TREATMENT OF CHRONIC ISCHEMIC HEART FAILURE
This study is designed to evaluate the efficacy and safety of the C3BS-CQR-1 in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy.
Patients with chronic heart failure secondary to ischemic cardiomyopathy being on standard of care will be screened per the protocol inclusion and exclusion criteria. Enrolled patients will be randomized on a 1:1 ratio to either standard of care and C3BS-CQR-1 injection (treatment group) or standard of care undergoing a sham procedure (control group). Patients randomized to the treatment group, for which C3BS-CQR-1 production met release criteria, will undergo endoventricular injection of the C3BS-CQR-1 using injection catheter. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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