Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774509
Status:
RECRUITING
Last Update Posted:
2023-09-25
First Post:
2023-02-20
Brief Title:
Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Treatment of Non-ischemic Dilated Cardiomyopathies by Intravenous Infusions of the Extracellular Vesicle-Enriched Secretome of Cardiovascular Progenitor Cells
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SECRET-HF
Brief 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
Are these repeated injections safe and well tolerated
Do they improve cardiac function and if yes to what extent
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-001844-75 | EUDRACT_NUMBER | None | None |
| PHRC-19-0330 | OTHER_GRANT | French ministry of health | None |