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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