A Phase IIa Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Non-ischemic Heart Failure
Overview
- Phase
- Phase 2
- Intervention
- Lactated Ringer's Solution
- Conditions
- Non-Ischemic Heart Failure
- Sponsor
- CardioCell LLC
- Enrollment
- 23
- Locations
- 5
- Primary Endpoint
- Safety Will be Evaluated by Number of AE
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic heart failure.
Detailed Description
A phase IIa, single-blind, placebo-controlled, crossover, multi-center, randomized study to assess the safety, tolerability, and preliminary efficacy of a single intravenous dose of ischemia-tolerant allogeneic mesenchymal bone marrow cells to subjects with heart failure of non-ischemic etiology.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females ≥18 years of age
- •LVEF ≤35% on echocardiogram within 12 months of randomization to undergo MRI
- •Screening cardiac MRI at baseline with:
- •Ejection fraction ≤40% No significant hyper enhancement on MRI scan in the opinion of the central imaging lab reviewer
- •Patients with non-ischemic heart failure etiology, as documented by absent or non-obstructive coronary artery disease on x-ray angiography or coronary computed tomography
- •Patients with history of heart failure and treated for at least three months with GDMT
- •NYHA class II-III symptoms
- •Ability to understand and provide signed informed consent
- •Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits
Exclusion Criteria
- •Pregnant or nursing women or those of childbearing age and not using an effective method of contraception
- •History of stroke within 3 months
- •Cardiac surgery within 3 months prior to randomization or the likelihood of a requirement for such procedures during the study period
- •Current ICD or CRT or implantation planned within 6 months of infusion
- •Presence of clinically significant, uncorrected valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension
- •History of cardiac arrest or life-threatening arrhythmias within 3 months
- •Treatment with parenteral inotropic agents within 1 month of randomization
- •Anticipated cardiac transplantation within 1 year
- •Illness other than heart failure with life expectancy less than 1 year
- •Received an experimental drug or device within 30 days of randomization
Arms & Interventions
Placebo:Lactated Ringer's Solution (LRS)
Intervention: One time intravenous infusion of 1.5mL/kg Lactated Ringer's Solution (LRS) administered at a constant rate of approximately 2mL/min.
Intervention: Lactated Ringer's Solution
Experimental: Human (aMBMC)
Intervention: One time intravenous infusion of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more.
Intervention: Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
Outcomes
Primary Outcomes
Safety Will be Evaluated by Number of AE
Time Frame: Total AEs and SAEs within 450 days post-infusion
As identified in the SAP, the safety analysis was the primary objective and was evaluated by the number of AEs
Secondary Outcomes
- Change in LVEF From Baseline to Day 90 Post-initial Infusion.(Baseline to Day 90)