A Study to Evaluate Autologous Bone Marrow Mononuclear Cells Using the CardiAMP™ Cell Therapy in Patients With Post Myocardial Infarction Heart Failure

Overview

About this study

The purpose of this study is to compare treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects will precede the randomised phase.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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) as defined by the following criteria:
    • Previous myocardial infarction (> 6 months) documented by a clinical history that includes an elevation of cardiac enzymes and/or ECG changes consistent with MI;
    • Treated with thrombolytic therapy, coronary artery bypass surgery, or percutaneous coronary revascularization.
  • Have an ejection fraction ≥ 20% and ≤ 40% by two-dimensional echocardiogram and not in the setting of a recent ischemic event, as assessed by the echocardiographic core laboratory.
  • 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.
    • Note: Stable pharmacological therapy is defined as changes not exceeding halving or doubling the medications listed below under 5.1; a transition between ACE inhibitors and ARB’s is allowed within the 3 months prior to randomization.
    • Pharmacological Therapy (as appropriate):
      • Angiotensin converting enzyme (ACE) inhibitors or angiotension II receptor blockers (ARB) for patients with ACE inhibitor intolerance or nitrate/hydralazine at the investigator’s discretion;
      • Beta blockers –If treated with beta blockers, they should be specifically approved for treating heart failure, except for those subjects with prior intolerance or if justified by their cardiologist;
      • Diuretics, aldosterone inhibitors.
    • Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy-Defibrillator (CRT-D):
      • If implanted with a CRT or CRT-D, it must be implanted > 3 months before randomization;
      • If currently eligible or anticipated to be eligible for CRT or CRT-D within 6 months, the patient should not be enrolled in the study.
  • Cell Potency Assay Score of 3, as determined by the Cell Analysis Core Lab results.
  • Provide written informed consent.
  • At screening, having the best performed 6-minute walk distance between 100 and 450 m.

Exclusion Criteria:

Patient History

  • Have a baseline glomerular filtration rate < 30 ml/min / 1.73m2.
  • Have a hematological abnormality as evidenced by hematocrit < 30%, white blood cell < 4,500/μl or platelet values, <100,000/μl without another explanation.
  • Have liver dysfunction, as evidenced by enzymes (AST and LT) greater than three times the ULN).
  • Have a coagulopathy (INR ≥ 1.5) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn before the procedure and confirmed to have an INR <1.5. 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 the 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 in this study.
    • Note:  patients who later develop a need for revascularization following enrollment will be submitted for this therapy without delay.
  • Have left ventricular thrombus, as detected by the echocardiographic core laboratory.
  • Have mitral or tricuspid regurgitation, defined as “severe”, as previously identified or as measured by the echocardiographic core laboratory.
  • Have a mechanical aortic valve or heart constrictive device.
  • Have a documented presence of aortic stenosis (aortic stenosis graded as > 2+ equivalent to an orifice area of 1.5cm2 or less), as measured by the echocardiographic core laboratory.
  • Have a documented presence of aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as > 2+), as measured by the echocardiographic core laboratory.
  • 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.
  • Have complete heart block or QTc interval > 550 ms on screening 12-lead EC.
  • 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.

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.
  • Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial or participated in the treatment arm of a gene or stem cell therapy trial within the previous 12 months.
  • Unwilling or unable to comply with follow-up.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

F Fortuin, M.D.

Open for enrollment

Contact information:

Emily Frank CCRN

Frank.Emily1@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20477929

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