Baby stem cells injected to fix failing hearts in kids and young adults
NCT ID NCT06464588
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests whether infusions of stem cells from donated newborn tissue are safe for young people aged 4 to 39 with dilated cardiomyopathy, a condition where the heart becomes enlarged and weak. Up to 36 participants will receive three intravenous doses over 30 days. Researchers will monitor for serious side effects and measure changes in heart function over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- neonatal mesenchymal stromal cells (nMSCs)
- What this could lead to
- If safe and effective, this could point toward a new treatment to improve heart function in people with dilated cardiomyopathy.
- What could go wrong
- This is a very early phase 1 trial with only 36 participants, focused on safety. It may not show clear benefit, and there are risks of severe side effects.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2027
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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4 to 40 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 * Phase 1A: Age greater than or equal to 16 years and less than 40 years (≥16 years, \<40 years). * Phase 1B: Age greater than or equal to 4 years and less than 16 years (≥4 years, \<16 years) * Subjects must be able to sign their own consent for Phase 1A of the study. * Diagnosis of dilated cardiomyopathy (DCM) defined as * Any Congenital Cardiac Malformation with systemic ventricular systolic dysfunction; Idiopathic Cardiomyopathy; Familial/Inherited and/or Genetic Cardiomyopathy; History of Myocarditis; Acquired (Chemotherapy, Iatrogenic, Infection, Rheumatic, Nutritional); Ischemic (e.g. Kawasaki Disease, post-operative); Left ventricular noncompaction; Coronary Artery Disease * Left ventricular ejection fraction less than or equal to 45% documented by two-dimensional echocardiogram or cardiac MRI within the prior six months. * Left ventricular dilation as defined by echocardiography left ventricular and end-diastolic dimension Z score \> +2.0 * Biventricular physiology with systemic left ventricle * Must receive guideline directed heart failure as defined by the American Heart Association, American College of Cardiology, and Heart Failure Society of America 118 * Have been unresponsive or poorly responsive to at least 3 months of maximum guideline directed treatments. Exclusion Criteria * Listed for heart transplantation (as UNOS status 1A) or hospitalized while waiting for transplant (while on inotropes or with ventricular assist device) * Cardiovascular surgery of percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 1A/1B. * Previous heart transplant recipient * Unoperated primary obstructive or severe regurgitant valve (aortic, pulmonary, mitral or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction anticipated to require surgical or transcatheter intervention within 6 months. * Restrictive or hypertrophic cardiomyopathy * Cardiogenic shock * Currently on extracorporeal membrane oxygenation support * Ventricular assist device support * Lethal, uncontrollable arrhythmia defined as an arrhythmia resulting in hemodynamic instability requiring need for defibrillation, continuous intravenous anti-arrhythmic medication or mechanical circulatory support * Patients with persistent atrial fibrillation requiring specific pharmacotherapy * Amyloidosis * Ischemic dilated cardiomyopathy * Clinical history of malignant neoplasm within 5 years (with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma) * Serious neurologic disorder including loss of vision, stroke, or paralysis * High-grade pulmonary embolism requiring interventional catheter procedure or pulmonary hypertension requiring use of pulmonary vasodilators including phosphodiesterase inhibitor or nitric oxide * High-grade renal failure \[eGFR\<45\] mL/min/1.73 m2 - serum potassium \>5.3 mmol/L * Multiple organ failure * Non-cardiac condition that limits life span for \<1 year * Uncontrolled diabetes (HbA1c \>9%) at screening * Active infection (including endocarditis) requiring pharmacotherapy * Sepsis * Active hemorrhagic disease (e.g., gastrointestinal bleeding, injury) * History of cardiac transplantation * Immune system-altering medications, or immunosuppressive therapy at the time of enrolment or within the prior 12 weeks * Dystrophin-associated cardiomyopathy confirmed by standard cardiomyopathy panel testing * Confirmed myocarditis at time of screening * Elevated LFTs greater than 2 times upper limit of normal at time of consent * Elevated WBC greater than upper limit of normal as defined by local lab at time of consent * Presence of HLA antibodies specific for therapeutic study product * History of noncompliance, alcohol abuse, recreational drug use, or incarceration within the last year * Currently pregnant or breastfeeding * Unsafe/unfeasible to enroll due to PI/designee discretion
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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
5 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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Arthur M. Blank Hospital
RECRUITINGAtlanta, Georgia, 30329, United States
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
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Grady Memorial Hospital
RECRUITINGAtlanta, Georgia, 30303, United States
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Hughes Spalding Children's Hospital
RECRUITINGAtlanta, Georgia, 30303, United States
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Scottish Rite Children's Hospital
RECRUITINGAtlanta, Georgia, 30342, United States
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Other studies related to the condition(s) this trial covers.
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