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Umbilical Cord Stem Cells for Ischemic Heart Disease

This study is testing umbilical cord-derived mesenchymal stromal cells (UC-MSCs), a type of stem cell, for people with ischemic heart disease (a condition where the heart doesn't get enough blood due to narrowed arteries). Researchers want to see if these cells, given into a vein, are safe and effective. You could be eligible if you are between 21 and 85 years old, have documented coronary artery disease (CAD) with heart muscle damage, and your heart's pumping ability (ejection fraction or EF) is 40% or less. The main goal is to see if these cells improve your heart's pumping ability 12 months after the first treatment. The study status is currently unclear.

Study design
This is a Phase IIA, randomized, double-blind, placebo-controlled study involving 60 participants. Participants will be randomly assigned to receive either UC-MSCs or a placebo.
What's involved
You would receive four infusions, two months apart. After each infusion, you'll be monitored for at least 2 hours, then examined at 1 week and 2 months.
Compensation
Not stated in the trial record.
Follow-up
Your heart's pumping ability will be measured at baseline and 12 months after the first infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06145035

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

Recruiting
PHASE2Ages 21–85InterventionalTreatment
Roberto Bolli
~60 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:umbilical cord-derived mesenchymal stromal cells (UC-MSCs)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change in LVEF (D LVEF) between baseline (M0) and 12 months after the first study product infusion (SPI) (M12)
Measured over Baseline, 12 months

Conditions

Ischemic Heart Disease

Explore related trials

Ischemic Heart Disease

Where it's being run

3 sites across 3 states
Florida1
Kentucky1
Texas1

Study leadership

  • Roberto Bolli, MD · PRINCIPAL_INVESTIGATOR · University of Louisville School of Medicine

Who to contact

Roberto Bolli, MD
[email protected]
502-608-5426
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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 5. Pacemaker dependence with an ICD (Note: pacemaker dependent candidates without an ICD are not excluded) 6. A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent. 7. Other MRI contraindications (e.g. patient body habitus incompatible with MRI) 8. An appropriate ICD firing or anti tachycardia pacing (ATP) for ventricular fibrillation or ventricular tachycardia within 30 days of consent 9. 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 10. Evidence of active myocarditis 11. Baseline glomerular filtration rate (eGFR) \< 35 ml/min/1.73m2 12. Blood glucose levels (HbA1c) \>10% 13. Hematologic abnormality evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet count \< 100,000/ul 14. Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3 times the ULN. 15. HIV and/or active HBV or HCV 16. Known history of anaphylactic reaction to penicillin or streptomycin 17. Received gene or cell based therapy from any source within the previous 12 months. 18. 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. 19. Condition that limits lifespan to \< 1 year 20. History of drug abuse (illegal "street" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 12 months. 21. Participation in an investigational therapeutic or device trial within 30 days of consent 22. Cognitive or language barriers that prohibit obtaining informed consent or any study elements 23. Pregnancy or lactation or plans to become pregnant in the next 12 months. 24. Any other condition that, in the judgment of the Investigator or Sponsor, would impair enrollment, study product administration, or follow up.

What this trial measures

  • change in LVEF (D LVEF) between baseline (M0) and 12 months after the first study product infusion (SPI) (M12)Baseline, 12 months

    Change in left ventricular ejection fraction as assessed via cardiac MRI. Units: %