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

NCT04476901 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-03-24

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Joshua M Hare

    lead OTHER

Principal Investigators

  • Joshua Hare, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04476901 on ClinicalTrials.gov