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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)

RecruitingPhase 1Ages 4 Years - 40 YearsAllEmory University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria * Phase 1A: Age greater than or equal to 16 years and less than 40 years (โ‰ฅ16 years, \<40 years). * Phase 1B: Age greater than or equal to 4 years and less than 16 years (โ‰ฅ4 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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What it tests

  • Allogeneic Neonatal mesenchymal stromal cells (nMSCs)
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Where

5 sites
Grady Memorial Hospital
Atlanta, United States
Hughes Spalding Children's Hospital
Atlanta, United States
Emory University Hospital
Atlanta, United States
Arthur M. Blank Hospital
Atlanta, United States
Scottish Rite Children's Hospital
Atlanta, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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