Clinical trial • Phase I • Cardiology

Adipose tissue-derived mesenchymal stromal/stem cells (AdMSC) for Critical limb ischemia

Phase I trial of Adipose tissue-derived mesenchymal stromal/stem cells (AdMSC) for Critical limb ischemia. None/Not specified-controlled. 10 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Critical limb ischemia
Trial Stage
Phase I
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
09-07-2024
First CTIS Authorization Date
07-10-2024

Trial design

None/Not specified-controlled Phase I trial across 3 sites in France.

Comparator
None/Not specified
Target Sample Size
10

Recruitment

Planned Sample Size
10
Recruitment Window Months
30

Geography

Total Number Of Sites
3
Total Number Of Participants
10

France

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
440
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service de chirurgie vasculaire et médecine vasculaire
Contact Person Name
Lucie CHASTAINGT
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de médecine interne et vasculaire
Contact Person Name
Joël CONSTANS
Contact Person Email
joel.constans@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de médecine vasculaire
Contact Person Name
François-Xavier LAPEBIE
Contact Person Email
lapebie.fx@chu-toulouse.fr

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
Allogeneic adipose tissue-derived mesenchymal stromal/stem cells (AdMSC) transplantation
Active Substance
Adipose tissue-derived mesenchymal stromal/stem cells (AdMSC)
Modality
Cell therapy

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