Congestive Heart Failure Cardiopoietic Regenerative Therpapy CHART-1 Trial Efficacy and Safety of Bone Marrow-Derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure - Congestive Heart failure cArdiopoietic Regenerative Therapy-1 (CHART-1) trial

Celyad SA0 sites240 target enrollmentAugust 29, 2013

ConditionsChronic advanced symptomatic heart failure secondary to ischemic cardiomyopathy MedDRA version: 18.1 Level: LLT Classification code 10010684 Term: Congestive heart failure System Organ Class: 100000004849 Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic advanced symptomatic heart failure secondary to ischemic cardiomyopathy
Sponsor: Celyad SA
Enrollment: 240
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 29, 2013

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Celyad SA

Eligibility Criteria

Inclusion Criteria

•Eligible patients must meet all of the following inclusion criteria:
•1\. Age ? 18 and \< 80 years.
•2\. Systolic dysfunction with LVEF ? 35% as assessed by echocardiography.
•3\. Ischemic heart failure without known need for revascularization.
•4\. Total MLHFQ score \> 30\.
•5\. Ability to perform a Six\-Minute Walk Test \> 100 m and ? 400 m.
•6\. History of hospitalization for HF within 12 months prior to screening or treatment in an out\-patient clinic with intravenous vasoactive therapy (including vasodilators, positive inotropic agents and vasopressors) or diuretics for worsening HF within 12 months prior to screening.
•7\. Be or must have been within the previous 12 months in NYHA class III or IV or INTERMACS class 4, 5, 6 or 7, and at the time of inclusion, must be at least in NYHA class II or greater.
•8\. Use of ACE inhibitor and/or ARB; and beta blocker, for at least 3 months prior to screening visit, unless intolerant or contraindicated.
•9\. Stable dosing of ACE inhibitor, ARB, beta blocker, aldosterone blocker, and diuretics for at least one month prior to screening visit, defined as ?50% change in total dose of each agent.

Exclusion Criteria

•Eligible patients must meet none of the following exclusion criteria:
•1\. Women who are pregnant, confirmed by a positive urine or serum hCG laboratory test at screening.
•2\. Women of child\-bearing potential without a negative serum or urine pregnancy test at screening or who are not practicing a reliable form of birth control. Women who are postmenopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level \> 40 mIU/ml or 6 weeks post surgical bilateral oophorectomy) or surgically sterile are not considered to be of child\-bearing potential. Reliable contraception includes surgical sterilization, hormonal contraception, or double\-barrier methods.
•3\. Men refusing to exercise a reliable form of contraception.
•4\. Myocardial infarction, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening, or CABG surgery within 180 days prior to screening.
•5\. Patient on a cardiac transplant list or previously received any solid organ transplant.
•6\. Previously underwent cardiac surgery with remodeling procedure, left ventricular assist device placement or cardiomyoplasty. This exclusion does not apply to patients who underwent ventricularplasty without placements device \>1 year ago.
•7\. Patient has undergone cardiac resynchronization therapy (CRT) within 6 months (180 days) prior to screening.
•8\. Severe uncontrolled HF requiring need for intensive intravenous diuretics or inotropic support within 1 month prior to screening.
•9\. Inability to perform a Six\-Minute Walk Test due to physical limitations other than HF including: