RecruitingIschemic Heart Disease
Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
Eligible age
21–85 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Roberto Bolli
You may qualify if…
- ✓ 1. Be ≥ 21 and ≤ 85 years of age.
- ✓ 2. Have documented CAD (\> 70% lesion in at least 1 epicardial vessel) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF.
- ✓ 3. Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by MRI.
- ✓ 4. Have an EF ≤ 40% by MRI.
- ✓ 5. 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.
- ✓ 6. Have NYHA class I, II or III symptoms of HF (see Appendix A)
- ✓ 7. 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…
- ✕ 1. 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.
- ✕ 2. Severe valvular (any valve) insufficiency and/or regurgitation within 12 months of consent
- ✕ 3. History of ischemic or hemorrhagic stroke within 90 days of consent
- ✕ 4. 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)
Where it's recruiting
Source: ClinicalTrials.gov · NCT06145035 · last updated 2026-05-13