NCT02317458

Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-2) Trial - THE CHART-2 TRIAL

EFFICACY AND SAFETY OF BONE MARROW-DERIVED MESENCHYMAL CARDIOPOIETIC CELLS (C3BS-CQR-1) FOR THE TREATMENT OF CHRONIC ISCHEMIC HEART FAILURE

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Celyad Oncology SA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	Experimental	One active arm with standard of car and treatment with C3BR-CQR-1 using intramyocardial injection
BIOLOGICAL	Sham comparator	One arm with standard of care undergoing a sham procedure

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-03-01
• First posted: 2014-12-16
• Last updated: 2016-07-11