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CellReady for the Treatment of Crohn's Fistula
NCT06636032Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2025
- Primary completion
- Sep 2027
- Countries
- 1
- Sponsor
- Centre hospitalier universitaire de Toulouse
- Modality
- Stem Cell Therapies
- Drugs
- CellReady
- Conditions
- perianal fistula
01
Overview
Phase 2, open-label, single-arm trial of CellReady in perianal fistula, sponsored by Centre hospitalier universitaire de Toulouse. Primary endpoints: Adverse events of grade >= 2 at 6 months, Efficacy of AdMSC by clinical evaluation at 6 months and 1 more. Started Mar 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
AdMSC (CellReady®)
Different doses of AdMSC will be tested for a dose escalation (5.10*7 and 10.10*7 cells) and injected in the wall of the fistula
03
Who it enrols
Adult patients with controlled luminal Crohn's disease and complex chronic perianal fistula who failed conventional treatment (drainage + anti-TNFα), excluding those with prior ALOFISEL treatment, recent cancer, or active infections.
04
Endpoints
Primary
Adverse events of grade >= 2
Efficacy of AdMSC by clinical evaluation
Efficacy of AdMSC by radiological evaluation
Secondary
Safety
Efficacy of AdMSC by clinical evaluation
Efficacy of AdMSC by biological evaluation
Quality of Life
Disease activity
Perianal disease activity
Lesions
Anal incontinence
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