RecruitingPhase 1NCT05774509

Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells

Treatment of Non-ischemic Dilated Cardiomyopathies by Intravenous Infusions of the Extracellular Vesicle-Enriched Secretome of Cardiovascular Progenitor Cells


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

12 participants

Start Date

May 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess the safety and efficacy of three intravenous injections of the extracellulat vesicle-enriched secretome of cardiovascular progenitor cells in severely symptomatic patients with drug-refractory left ventricular (LV) dysfunction secondary to non-ischemic dilated cardiomyopathy. The main questions it aims to answer are: * Are these repeated injections safe and well tolerated? * Do they improve cardiac function and, if yes, to what extent?


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an experimental treatment using extracellular vesicles (tiny particles secreted by heart progenitor cells) given intravenously for people with dilated cardiomyopathy — a condition where the heart muscle becomes enlarged and weak, reducing its ability to pump blood. The treatment aims to help the heart muscle recover. **You may be eligible if...** - You are between 18 and 80 years old - You have dilated cardiomyopathy with a significantly reduced heart pumping function (ejection fraction of 40% or less) - The weakened heart is not explained by blocked arteries, high blood pressure, or valve disease - If caused by chemotherapy, you have been cancer-free for at least 2 years - You have French social security coverage **You may NOT be eligible if...** - Your heart failure is caused by coronary artery disease, severe valve disease, or uncontrolled high blood pressure - You have active cancer or have been in remission less than 2 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

BIOLOGICALExtracellular vesicle-enriched secretome of cardiovascular progenitor cells differentiated from induced pluripotent stem cells

Repeated (X3) intravenous infusions of the extracellular vesicle-enriched secretome of cardiovascular progenitor cells (differentiated from human induced pluripotent stem cells)


Locations(1)

Hôpital européen Georges Pompidou

Paris, France

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NCT05774509


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