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Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy

ConditionNon-ischemic Dilated Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJoshua M Hare

About this trial

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form.

Diagnosis of NIDCM with left ventricular ejection fraction ≤45%.

Appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy. At a minimum, subjects must be on beta blockers and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical indication precluding use of one or both of these agents. Subjects must be on a stable regimen for at least 30 days prior to the procedure. Dose titration is allowed.

Be a candidate for cardiac catheterization*

Disqualifiers

Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of non-ischemic dilated cardiomyopathy

Clinical manifestation of coronary artery disease (CAD) (e.g., chest pain and concomitant clinical findings such as electrocardiogram changes suggestive of coronary ischemia, myocardial infarction) or evidence of endocardial or transmural scar on cardiac MRI suggestive of undiagnosed CAD or history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Be indicated for or require coronary artery revascularization

Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries

Valvular heart disease including 1) aortic valve prosthesis, mechanical mitral valve, and mitral valve clip; 2) severe aortic valve insufficiency/regurgitation within 12 months of consent*

Trial design

Design model

Parallel

Treatments tested in this trial

  • allogeneic human mesenchymal stem cells (hMSCs)

    Biological/Vaccine

    allo-hMSCs, 16-20 million cells/ml delivered at a dose of 0.5 ml/ injection x 10 injections for a total of 80-100 million allo-hMSCs or a single administration of intravenous allogeneic hMSCs (100 million).

  • Placebo

    Other intervention

    Placebo will be administered as injections of plasmalyte A supplemented with 1% of 25% human serum albumin (HSA). 0.5 ml/ injection x 10 injections or an intravenous placebo infusion of Cell-free PlasmaLyte-A medium supplemented with 1% of 25% human serum albumin (HSA)

Treatment groups

136 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Genotype A administered with placebo GroupPlacebo comparator 1 intervention
Group B: Genotype A administered with hMSC GroupExperimental treatment 1 intervention
Group C: Genotype B administered with placebo GroupPlacebo comparator 1 intervention
Group D: Genotype B administered with hMSC GroupExperimental treatment 1 intervention
Group E: Genotype C administered with placebo GroupPlacebo comparator 1 intervention
Group F: Genotype C administered with hMSC GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in LVEF

Change in Left Ventricular Ejection Fraction (LVEF) as assessed via cardiac Magnetic Resonance Imaging (MRI)

Time frame
Baseline, 12 months

Secondary outcomes

1

Change in global ventricular strain

Change in global ventricular strain as assessed via cardiac Harmonic Phase (HARP) MRI

Time frame
Baseline, 12 months
2

Change in left regional strain

Change in regional ventricular strain as assessed via cardiac HARP MRI

Time frame
Baseline, 12 months
3

Left ventricular function concordance

The left ventricular function concordance will be measured as the Number of individuals who experienced an increase in left ventricular ejection fraction (LVEF) and a simultaneous decrease in both left ventricular end systolic volume index (LVESVI) and left ventricular end diastolic volume index (LVEDVI)

Time frame
12 months
4

Change in LVEDVI

Change in left ventricular end diastolic index (LVEDVI) as assessed via cardiac MRI

Time frame
Baseline, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joshua M Hare

Lead sponsor

University of Miami

Sponsor institution

United States Department of Defense

Collaborator

The University of Texas Health Science Center, Houston

Collaborator

Source ClinicalTrials.gov
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