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Tests treatment safety and results for Dilated Cardiomyopathy
Official title A Phase 1 Open-Label Study of the Safety of Intravenous Allogeneic Neonatal Mesenchymal Cells (nMSCs) in Young Adult (1A) and Pediatric (1B) Patients With Dilated Cardiomyopathy (DCM)
ClinicalTrials.gov ID: NCT06464588
What this study is testing
What is Allogeneic Neonatal mesenchymal stromal cells (nMSCs)?
Allogeneic Neonatal mesenchymal stromal cells (nMSCs) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dilated cardiomyopathy.
Also referred to as nMSCs infusions.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1 study to determine the safety and efficacy of allogeneic neonatal mesenchymal stromal cells (nMSCs) for the treatment of Dilated Cardiomyopathy. The purpose of the study is to help doctors and scientists learn if allogeneic neonatal mesenchymal stromal cells (nMSCs) infusions are a safe and effective way to improve cardiac function and left ventricular ejection fraction.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 40
You may be able to join if
- 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)
- people 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...
You likely can't join if
- Listed for heart transplantation (as UNOS status 1A) or hospitalized while waiting for transplant (while on inotropes or with ventricular assist...
- Cardiovascular surgery of percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening...
- Previous heart transplant recipient
- Unoperated primary obstructive or severe regurgitant valve (aortic, pulmonary, mitral or tricuspid) disease, or significant systemic ventricular...
- Restrictive or hypertrophic cardiomyopathy
- Cardiogenic shock
See the full eligibility 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)
- people 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...
- 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.
- 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...
- 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...
- 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 treatment catheter procedure or pulmonary hypertension requiring use of pulmonary vasodilators including phosphodiesterase inhibitor or nitric oxide
- High-grade renal failure [eGFR\ 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.