Clinical trial • Phase I • Neurology

Adipose tissue-derived mesenchymal stromal cells for Primary progressive multiple sclerosis

Phase I trial of Adipose tissue-derived mesenchymal stromal cells for Primary progressive multiple sclerosis. open-label, none/not specified-controlled.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Primary progressive multiple sclerosis
Trial Stage
Phase I
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
29-01-2024
First CTIS Authorization Date
04-07-2024

Trial design

open-label, none/not specified-controlled Phase I trial across 2 sites in France.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
15

Eligibility

Recruits 15 Vulnerable population not selected; no special consent/assent handling described..

Vulnerable Population
Vulnerable population not selected; no special consent/assent handling described.

Recruitment

Planned Sample Size
15
Recruitment Window Months
57

Geography

Total Number Of Sites
2
Total Number Of Participants
15

France

Earliest CTIS Part Ii Submission Date
08-04-2024
Latest Decision Or Authorization Date
07-08-2025
Processing Time Days
486
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
clinical investigation department
Contact Person Name
Philippe Le Corvoisier
Contact Person Email
philippe.lecorvoisier@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
neurology
Contact Person Name
Laure Michel
Contact Person Email
laure.michel@chu-rennes.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Rennes
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Allogenic Adipose tissue-derived Mesenchymal Stromal Cells
Active Substance
Adipose tissue-derived mesenchymal stromal cells
Modality
Cell therapy

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