Clinical trial • Phase I • Gastroenterology
Adipose-derived stromal/stem cells for Perianal fistulizing Crohn's disease
Phase I trial of Adipose-derived stromal/stem cells for Perianal fistulizing Crohn's disease. 9 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Perianal fistulizing Crohn's disease
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 12-09-2024
Trial design
Phase I trial across 1 site in France.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 9
Eligibility
Recruits 9 No vulnerable population selected; consent or assent handling not specified in the provided record..
- Vulnerable Population
- No vulnerable population selected; consent or assent handling not specified in the provided record.
Recruitment
- Planned Sample Size
- 9
- Recruitment Window Months
- 30
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 9
France
- Earliest CTIS Part Ii Submission Date
- 08-07-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 574
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Etienne BUSCAIL
- Principal Investigator Email
- buscail.e@chu-toulouse.fr
- Contact Person Name
- Etienne BUSCAIL
- Contact Person Email
- buscail.e@chu-toulouse.fr
- Number Of Participants
- 9
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-derived stromal/stem cells
- Active Substance
- Adipose-derived stromal/stem cells
- Modality
- Cell therapy
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