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 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
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.
Emory University
Lead sponsor
The Marcus Foundation
Collaborator