Efficacy and Safety of Bone Marrow-derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure. (CHART-1)

NCT01768702 Phase 3 COMPLETED

Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.

Details

Lead sponsor	Celyad Oncology SA
Phase	Phase 3
Status	COMPLETED
Enrolment	315
Start date	2012-11
Completion	2017-08

Conditions

• Heart Failure

Interventions

• Injection of C3BS-CQR-1
• Sham, no injection

Primary outcomes

• Efficacy between groups post-index procedure — 39 weeks post-index
  Change between groups from baseline and 39 weeks in a hierarchical composite outcome comprising, from most to least severe outcome, days to death from any cause, number of worsening of heart failure events, change in score for the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (10-point deterioration, no meaningful change,10-point improvement), change in six-minute walk distance (40-m deterioration, no meaningful change, 40-m improvement) and change in left ventricular end systolic volume (15-mL deterioration, no meaningful change, 15-mL improvement), and left ventricular ejection fraction (4% absolute deterioration, no meaningful change, 4% absolute improvement).

Countries

Belgium, Bulgaria, Hungary, Israel, Italy, Poland, Serbia, Spain, Switzerland