Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-2) Trial - THE CHART-2 TRIAL (CHART-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02317458|
Recruitment Status : Unknown
Verified July 2016 by Celyad Oncology SA.
Recruitment status was: Not yet recruiting
First Posted : December 16, 2014
Last Update Posted : July 11, 2016
Celyad Oncology SA
Information provided by (Responsible Party):
Celyad Oncology SA
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Biological: Experimental Biological: Sham comparator||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||EFFICACY AND SAFETY OF BONE MARROW-DERIVED MESENCHYMAL CARDIOPOIETIC CELLS (C3BS-CQR-1) FOR THE TREATMENT OF CHRONIC ISCHEMIC HEART FAILURE|
|Study Start Date :||June 2017|
|Estimated Primary Completion Date :||March 2020|
Experimental: Active arm
One arm with standard of care and C3BS-CQR-1 injection (treatment group) using intramyocardial catheter injection.
One active arm with standard of car and treatment with C3BR-CQR-1 using intramyocardial injection
Other Name: C3BR-CQR-1
Sham Comparator: Control arm
One arm with standard of care undergoing a sham procedure (control group)using intramyocardial catheter injection. .
Biological: Sham comparator
One arm with standard of care undergoing a sham procedure
Primary Outcome Measures :
- Efficacy of C3BS-CQR-1 injection based on a hierarchical composite score [ Time Frame: 52 weeks ]
- Died of CV cause
- Hospitalized 2 or more times for HF
- Hospitalized once for HF
- Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score worsened by 10 or more points
- MLHFQ total score neither worsened by 10 or more points nor improved by 10 or more points, or died of non-CV cause
- MLHFQ total score improved by 10 or more points
No Contacts or Locations Provided