General Information |
| 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? |
| 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:
The tissue-repair capacity of transplanted cells can be duplicated by the delivery of the extracellular vesicles (EV) that they secrete.
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.
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. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2023-05-31 |
| End date (estimated) |
2026-07-15 |
| Clinical feature |
| Label |
dilated cardiomyopathy |
| Link |
http://purl.obolibrary.org/obo/DOID_12930 |
| Description |
An intrinsic cardiomyopathy that is characterized by an an enlarged heart and damage to the myocardium causing the heart to pump blood inefficiently.; Xref MGI. OMIM mapping confirmed by DO. [LS]. |
|
Administrative Information |
| NCT number |
NCT05774509 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05774509 |
| EudraCT number |
2022-001844-75 |
| Other study identifiers |
| Name |
PHRC-19-0330 |
| Description |
(Other Grant/Funding Number: French ministry of health) |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT05774509 |
| Sponsors |
Assistance Publique - Hôpitaux de Paris
|
| Collaborators |
|
Cells |
| Which differentiated cell type is used |
| Label |
Extracellular Vesicle |
| Link |
http://purl.obolibrary.org/obo/NCIT_C153165 |
| Description |
Bilayer membrane fragments present in the blood plasma that are released by different cell types upon activation or death. Extracellular vesicles are usually classified as either exosomes (formed by the membranes of intracellular compartments, 50-100 nm in diameter) and ectosomes (also called microparticles or microvesicles, formed from plasma membrane, 100-1000 nm in diameter). |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
12 |
