NCT04476901

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

A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Administration of Allogeneic-MSC Versus Placebo in Patients With Non- Ischemic Dilated Cardiomyopathy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Joshua M Hare · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.

Conditions

• Non-ischemic Dilated Cardiomyopathy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-05-07
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2020-07-20
• Last updated: 2026-03-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study