Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy

PHASE2RecruitingINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

May 7, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Non-ischemic Dilated Cardiomyopathy
Interventions
BIOLOGICAL

allogeneic human mesenchymal stem cells (hMSCs)

allo-hMSCs, 16-20 million cells/ml delivered at a dose of 0.5 ml/ injection x 10 injections for a total of 80-100 million allo-hMSCs or a single administration of intravenous allogeneic hMSCs (100 million).

OTHER

Placebo

Placebo will be administered as injections of plasmalyte A supplemented with 1% of 25% human serum albumin (HSA). 0.5 ml/ injection x 10 injections or an intravenous placebo infusion of Cell-free PlasmaLyte-A medium supplemented with 1% of 25% human serum albumin (HSA)

Trial Locations (4)

33136

RECRUITING

University of Miami Miller School of Medicine, Miami

40202

RECRUITING

University of Louisville, Louisville

77030

RECRUITING

Texas Heart Institute, Houston

94304

RECRUITING

Stanford University, Stanford

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

The University of Texas Health Science Center, Houston

OTHER

lead

Joshua M Hare

OTHER