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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart Failure

Study category: Heart and Blood Conditions

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Description

This study examines the use of stem cells to help the hearts of people who have heart failure as a result of a heart attack. Study subjects are randomized 3:2 to the treatment arm using the CardiAMP cell therapy system (Treatment Group) vs. a sham control. Subjects will be evaluated for 12 months thereafter to determine whether there is an improvement in walking distance, future heart attacks or hospitalizations, and/or survival.

Details
Age

Adult

Eligibility

New York Heart Association (NYHA) Class II or III. A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI). Have an ejection fraction ≥ 20% and ≤ 40%. On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization. Cell Potency Assay Score of 3, as determined by the Cell Analysis Core Lab results. Provide written informed consent.

Detailed Eligibility: Ages Eligible for Study: 21 Years to 90 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Greater than (>) 21 and less than (<) 90 years of age. New York Heart Association (NYHA) Class II or III. A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI). Have an ejection fraction ≥ 20% and ≤ 40%. On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization. Cell Potency Assay Score of 3, as determined by the Cell Analysis Core Lab results. Provide written informed consent. Exclusion Criteria: Have a baseline glomerular filtration rate <50 ml/min/1.73m2. Have a hematological abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values, <100,000/ul without another explanation. Have liver dysfunction, as evidenced by enzymes (AST and LT) greater than three times the ULN. Have a coagulopathy (INR ≥ 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn before the procedure and confirmed to have an INR <1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment. Be an organ transplant recipient. Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma. Be serum positive for hepatitis B/C and or HIV, unless patient is a carrier for Hepatitis B/C, but has never had an active flare. History of bronchospastic lung disease (asthma or chronic obstructive pulmonary disease), orthopedic, muscular or neurologic conditions that could limit the ability to perform 6 Minute Walk Distance Test. Have a known, serious radiological contrast allergy. Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods for at least 30 days prior to randomization. Not a candidate for cardiac catheterization. Cardiac or Vascular System Require coronary artery revascularization. Patients who require or undergo revascularization procedures would undergo these procedures a minimum of 3 months in advance of randomization. Have a left ventricle thrombus, as detected by the echocardiographic core laboratory. Have mitral regurgitation, defined as "severe", as measured by the echocardiographic core laboratory. Have a mechanical aortic valve or heart constrictive device. Have severe mitral or tricuspid insufficiency. Have a documented presence of aortic stenosis (aortic stenosis graded as > + 2 equivalent to an orifice area of 1.5cm2 or less), as detected by the echocardiographic core laboratory. Have a documented presence of aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ + 2). Acute coronary syndrome within 3 months. Have evidence of a life-threatening arrhythmia (non-sustained ventricular tachycardia ≥ 20 consecutive beats) or sustained or short run (>20 consecutive beats) ventricular tachycardia during the screening Holter Monitoring. AICD firing in the past 60 days prior to the procedure. Have peripheral artery disease involving the aorta or iliofemoral system that impacts the feasibility or safety of the study intervention. This includes stenotic or aneurysmal or embolic disease, and symptom limiting claudication. Have complete heart block or QTc interval >550 ms on screening 12-lead ECG. Other Have a non-cardiac condition that limits lifespan to < 1 year. Have a history of drug or alcohol abuse within the past 24 months.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Natasha Altman,  MD

Natasha Altman, MD

Study ID

Protocol Number: 18-0158

More information available at ClinicalTrials.gov: NCT02438306

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