Clinical trial • Phase I • Cardiology
Extracellular vesicle-enriched secretome of cardiovascular progenitor cells for Non-ischemic dilated cardiomyopathy
Phase I trial of Extracellular vesicle-enriched secretome of cardiovascular progenitor cells for Non-ischemic dilated cardiomyopathy. 12 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Non-ischemic dilated cardiomyopathy
- Trial Stage
- Phase I
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 16-10-2024
- First CTIS Authorization Date
- 08-11-2024
Trial design
Phase I trial across 1 site in France.
- Target Sample Size
- 12
- Trial Duration For Participant
- 1503
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 49
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 12
France
- Earliest CTIS Part Ii Submission Date
- 04-10-2024
- Latest Decision Or Authorization Date
- 17-12-2025
- Processing Time Days
- 439
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Department of Cardiovascular Surgery
- Principal Investigator Name
- Philippe MENASCHE
- Principal Investigator Email
- philippe.menasche@aphp.fr
- Contact Person Name
- Philippe MENASCHE
- Contact Person Email
- philippe.menasche@aphp.fr
- Number Of Participants
- 12
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Extracellular vesicle-enriched secretome of cardiovascular progenitor cells
- Active Substance
- Extracellular vesicle-enriched secretome of cardiovascular progenitor cells
- Modality
- Other
- Routes Of Administration
- Intravenous infusion
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