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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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
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:
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
Any contraindication for gadolinium use for MRI
Patient scheduled for hospice care
Clinically relevant abnormal findings in the clinical history, physical examination, ECG, or laboratory tests at the screening assessment that would interfere with the objectives of the study or would preclude safe completion of the study. Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as patients undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury
Any other medical, social, or geographical factor that would make it unlikely that the patient could comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or noncompliance)
Primary purpose
Allocation
Interventional model
Masking
23 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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