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)

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 14, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2027

Conditions
Dilated Cardiomyopathy
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.

Trial Locations (5)

30303

RECRUITING

Hughes Spalding Children's Hospital, Atlanta

30322

RECRUITING

Egleston Children's Hospital, Atlanta

RECRUITING

Emory Children's Center, Atlanta

RECRUITING

Emory University Hospital, Atlanta

30342

RECRUITING

Scottish Rite Children's Hospital, Atlanta

All Listed Sponsors
collaborator

The Marcus Foundation

OTHER

lead

Emory University

OTHER