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RECRUITING
NCT06464588
PHASE1

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

4 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-07-14

Completion Date

2027-07

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Allogeneic 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.

Locations (5)

Hughes Spalding Children's Hospital

Atlanta, Georgia, United States

Egleston Children's Hospital

Atlanta, Georgia, United States

Emory Children's Center

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Scottish Rite Children's Hospital

Atlanta, Georgia, United States