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Cord blood stem cells aim to repair damaged hearts

NCT ID NCT06145035

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

21 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Texas Heart Institute Houston Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Louisville School of Medicine, Institute of Molecular Cardiology

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Miami Miller School of Medicine

    RECRUITING

    Miami, Florida, 33136, United States

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