Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure

Completed · Phase 2 · Has a placebo group

Conditions studied: Ischemic Cardiomyopathy

In brief

This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.

Key facts

Study ID

NCT02501811

Run by

The University of Texas Health Science Center, Houston

People needed

125

Starts

2015-10-01

Expected to finish

2020-07-22

Last updated by the study team

2021-04-26

Who can join

Age: 21 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be ≥ 21 and <80 years of age
• Have documented coronary artery disease (CAD) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF
• Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by cMRI
• Have an EF ≤ 40% by cMRI
• Be receiving guideline-driven medical therapy for heart failure at stable and tolerated doses for ≥ 1 month prior to consent. For beta-blockade "stable" is defined as no greater than a 50% reduction in dose or no more than a 100% increase in dose.
• Be a candidate for cardiac catheterization
• Have NYHA class I, II, or III heart failure symptoms
• If a female of childbearing potential, be willing to use one form of birth control for the duration of the study, and undergo a pregnancy test at baseline and within 36 hours prior to injection

You may not qualify if…

• Indication for standard-of-care surgery (including valve surgery, placement of left-ventricular assist device, or imminent heart transplantation), coronary artery bypass grafting (CABG) procedure, and/or percutaneous coronary intervention (PCI) for the treatment of ischemic and/or valvular heart disease. Subjects who require or undergo PCI should undergo these procedures a minimum of 3 months in advance of randomization. Subjects who require or undergo CABG should undergo these procedures a minimum of 4 months in advance of randomization. In addition, subjects who develop a need for revascularization following enrollment should undergo revascularization without delay. Indication for imminent heart transplantation is defined as a high likelihood of transplant prior to collection of the 12 month study endpoint. Candidates cannot be UNOS status 1A or 1B, and they must have documented low probability of being transplanted
• Valvular heart disease including 1) mechanical or bioprosthetic heart valve; or 2) severe (any valve) insufficiency/regurgitation within 12 months of consent
• Aortic stenosis with valve area ≤ 1.5 cm2
• History of ischemic or hemorrhagic stroke within 90 days of consent
• History of a left ventricular remodeling surgical procedure utilizing prosthetic material
• Presence of a pacemaker and/or implantable cardioverter-defibrillator (ICD) generator with any of the following limitations/conditions:
• manufactured before the year 2000
• leads implanted < 6 weeks prior to consent
• non-transvenous epicardial, or abandoned leads
• subcutaneous ICDs
• leadless pacemakers
• any other condition that, in the judgment of device-trained staff, would deem an MRI contraindicated
• Pacemaker-dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded)
• A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent
• Other MRI contraindications (e.g. patient body habitus incompatible with MRI)
• An appropriate ICD firing or anti-tachycardia pacing (ATP) for ventricular fibrillation or ventricular tachycardia within 30 days of consent
• Ventricular tachycardia ≥ 20 consecutive beats without an ICD within 3 months of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent
• Presence of LV thrombus
• Evidence of active myocarditis
• Baseline maximal oxygen consumption (VO2 max) greater than 75% of age and gender based predictive values
• Baseline eGFR <35 ml/min/1.73m2
• Blood glucose levels (HbA1c) >10%
• Hematologic abnormality evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet count < 100,000/ul
• Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3 times the upper limit of normal (ULN)
• Coagulopathy (INR ≥ 1.3) not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors). Subjects who cannot be withdrawn from anticoagulation will be excluded.

Where it is running

• Stanford University School of Medicine (Falk Cardiovascular Research Center) — Stanford, California, United States
• University of Florida-Department of Medicine — Gainesville, Florida, United States
• University of Miami-Interdisciplinary Stem Cell Institute — Miami, Florida, United States
• Indiana Center for Vascular Biology and Medicine — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Texas Heart Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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