A Study to Assess the Effect of Intravenous Dose of (aMBMC) to Subjects With Non-ischemic Heart Failure

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Ischemic Heart Failure

In brief

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.

Key facts

Study ID

NCT02467387

Run by

CardioCell LLC

People needed

23

Starts

2014-06-01

Expected to finish

2017-05-11

Last updated by the study team

2020-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Left ventricular assist device or implantation planned in the next 6 months
• Patients with complex congenital heart disease
• Uncontrolled seizure disorder
• Presence of immune deficiency
• Clinically significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests:
• Liver disease = ALT or AST > 3x normal, alkaline phosphatase or bilirubin >2x normal)
• Renal disease = estimated glomerular filtration rate as assessed by the MDRD formula <30 ml/min
• Hematologic = Unexplained leukocytosis >10 or hemoglobin < 9gm/dl
• Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the investigator or sponsor for which participation in the study would pose a safety risk to the subject
• Inability to comply with the conditions of the protocol
• Malignancy within the previous five years, except adequately treated basal cell carcinoma, provided that it is neither infiltrating nor sclerosing, and carcinoma in situ of the cervix
• Active myocarditis or early postpartum cardiomyopathy (within six months).
• Systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment
• Porphyria
• Allergy to sodium citrate or any "caine" type of local anesthetic

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern University Centers for Heart Failure Therapy — Chicago, Illinois, United States
• Stony Brook Heart Institute — Stony Brook, New York, United States
• Hospital of the University of Pennsylvania, Heart Failure and Transplant Program — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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