Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ischemic Heart Disease

In brief

This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs, stem cells), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).

Key facts

Study ID

NCT06145035

Run by

Roberto Bolli

People needed

60

Starts

2024-03-04

Expected to finish

2028-09-01

Last updated by the study team

2026-05-13

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be ≥ 21 and ≤ 85 years of age.
• Have documented CAD (> 70% lesion in at least 1 epicardial vessel) 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 MRI.
• Have an EF ≤ 40% by MRI.
• Be receiving guideline driven medical therapy for HF (beta blockers, diuretics, ACE inhibitors or ARBs, or ARNIs, aldosterone antagonists, hydralazine isosorbide, sodium-glucose transporter 2 inhibitors) ) at stable, maximally tolerated doses for ≥ 1 month prior to consent. "Stable" is defined as stable dose with no changes for 30 days after last dose adjustment. For beta blockade "stable" is defined as no greater than a 50% reduction in dose or no more than a 100% increase in dose.
• Have NYHA class I, II or III symptoms of HF (see Appendix A)
• If a female of childbearing potential, be willing to use one form of birth control for the duration of the study and undergo a serum pregnancy test at baseline and within 36 hours prior to infusion

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 3 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 1A or 1B, and they must have documented a low probability of being transplanted.
• Severe valvular (any valve) insufficiency and/or regurgitation within 12 months of consent
• History of ischemic or hemorrhagic stroke within 90 days of consent
• Presence of a pacemaker and/or implantable cardiac device (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 (if not MRI compatible)
• 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
• Evidence of active myocarditis
• Baseline glomerular filtration rate (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 ULN.
• HIV and/or active HBV or HCV
• Known history of anaphylactic reaction to penicillin or streptomycin
• Received gene or cell based therapy from any source within the previous 12 months.
• History of malignancy within 2 years (i.e., subjects with prior malignancy must be disease free for 2 years), excluding basal cell carcinoma and cervical carcinoma in situ which have been definitively treated.
• Condition that limits lifespan to < 1 year

Where it is running

• University of Miami Miller School of Medicine — Miami, Florida, United States (enrolling)
• University of Louisville School of Medicine, Institute of Molecular Cardiology — Louisville, Kentucky, United States (enrolling)
• The Texas Heart Institute Houston Texas — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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