Cord blood stem cells aim to repair damaged hearts
NCT ID NCT06145035
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether stem cells from umbilical cords can safely improve heart function in people with heart failure due to blocked arteries. Sixty participants will receive either one or two doses of stem cells or a placebo through an IV. The main goal is to see if the heart's pumping ability improves after 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord stem cells
- What this could lead to
- If successful, this could lead to a new treatment that improves heart function in people with heart failure caused by blocked arteries.
- What could go wrong
- This is an early Phase 2 trial with only 60 people, so results may not apply to everyone. Stem cell treatments can have unknown long-term effects, and the improvement in heart function may be small or not lasting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Exclusion Criteria: 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) * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Texas Heart Institute Houston Texas
RECRUITINGHouston, Texas, 77030, United States
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University of Louisville School of Medicine, Institute of Molecular Cardiology
RECRUITINGLouisville, Kentucky, 40202, United States
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University of Miami Miller School of Medicine
RECRUITINGMiami, Florida, 33136, United States
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