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Clinical Trial 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?


Clinical Trial Description

The overall objective of this study is to assess the safety and efficacy of repeated intravenous injections of the secretome of cardiovascular progenitor cells in severely symptomatic patients with drug-refractory left ventricular (LV) dysfunction secondary to non-ischemic dilated cardiomyopathy. The rationale and design of this trial are based on three main assumptions: 1. The tissue-repair capacity of transplanted cells can be duplicated by the delivery of the extracellular vesicles (EV) that they secrete. 2. The greatest therapeutic efficacy seems to be achieved by using secreting cells that are committed to the same lineage as those of the tissue to be repaired, hence, the use of cardiovascular progenitor cells as the source of the EV-enriched secretome. 3. Leveraging the benefits of cells, or their secreted products, by repeated administrations requires a non-invasive approach, which highlights the potential interest of the intravenous approach. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05774509
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Touria EL AAMRI
Phone +33140271848
Email touria.el-aamri@aphp.fr
Status Recruiting
Phase Phase 1
Start date May 31, 2023
Completion date July 15, 2026

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