RecruitingPhase 2NCT04476901

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


Sponsor

Joshua M Hare

Enrollment

136 participants

Start Date

May 7, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a treatment using donated stem cells (allogeneic mesenchymal stem cells, or MSCs) can help patients with non-ischemic dilated cardiomyopathy (NIDCM) — a type of heart failure where the heart muscle becomes weakened and enlarged, but not because of blocked arteries. The MSCs are injected directly into the heart via a catheter-based procedure. Researchers hope this therapy can help the heart heal and pump better. You may be eligible if: - You are between 18 and 80 years old - You have been diagnosed with NIDCM and your heart's pumping function (ejection fraction) is 45% or less - You have been on stable, guideline-recommended heart failure medications (including beta blockers and ACE inhibitors/ARBs or equivalent) for at least 30 days - You are a candidate for cardiac catheterization and willing to undergo a DNA test You may NOT be eligible if: - You have or need surgical or interventional treatment for the cardiomyopathy - You have known coronary artery disease or signs of it on MRI - You have significant valve disease or severe aortic stenosis - You have cardiomyopathy due to hypertrophic, non-compaction, or recent postpartum causes - You have a QTc interval over 550 ms, severe anemia, significant kidney disease, liver dysfunction, bleeding disorder, or active infection - You are HIV positive, or have active Hepatitis B or C - You have had a cancer diagnosis in the last 12 months - You are pregnant or breastfeeding - You have other significant MRI contraindications Talk to your cardiologist if you have heart failure not caused by blocked arteries and want to explore this experimental stem cell therapy.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALallogeneic 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).

OTHERPlacebo

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)


Locations(4)

Stanford University

Stanford, California, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

University of Louisville

Louisville, Kentucky, United States

Texas Heart Institute

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04476901


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