RecruitingPhase 1NCT06464588

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)

Sponsor

Emory University

Enrollment

36 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Dilated Cardiomyopathy

Summary

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.

Eligibility

Min Age: 4 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Allogeneic Neonatal mesenchymal stromal cells (nMSCs) for people with dilated cardiomyopathy. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 4 Years to 30 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogeneic Neonatal mesenchymal stromal cells (nMSCs)

nMSCs will be administered intravenously in the predefined dose per each group. The rate of infusion will be approximately 30- 60 minutes at 0, 15 and 30 days, with escalating dose levels.