Actively Recruiting
Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula
Led by University Hospital, Toulouse · Updated on 2025-12-24
9
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Perianal fistulas are in the forefront (42 to 72, 4%) of morbid complication of Crohn's disease, affecting nearly one- third of patients and complicating abscesses in 35-48% of cases. The current treatment is based on the combination of drainage (proctologic and surgical), and biologics techniques, but the failure rate varies from 30 to 80%. Actually, innovative cell therapy procedures are validated by Cell-Easy with the use of allogenic mesenchymal stem cells for the immunomodulatory, anti-inflammatory, angiogenic and trophic properties (CellReady®) and represent a promising option in the treatment of perianal fistulas associated with Crohn's disease. This phase I/II study is designed to evaluate the treatment of complex perianal fistulas associated with Crohn's disease, after failure of conventional treatment by injection of allogeneic cultured adipose-derived stromal cell (AdMSC) into the fistula.
CONDITIONS
Official Title
Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Patients who signed the informed consent
- Patient affiliated to a social security system
- Controlled luminal Crohn's disease with Harvey-Bradshaw score ≤ 8 diagnosed clinically, endoscopically, histologically, and/or radiologically for more than 3 months
- Colonoscopy within the last year showing no ulcer in the rectum
- Presence of complex chronic perianal fistula with up to two internal and three external openings
- Patient treated with combined drainage on setons and anti-TNF alpha therapy for at least 6 months who failed conventional treatment and has controlled intraluminal disease
You will not qualify if you...
- Patient refusal to participate
- Positive QuantiFERON test
- History of organ transplant
- Cancer or lympho-proliferative disease in the past 5 years
- Persistent bacterial or viral infection
- Contraindication to MRI
- Known allergy to Gadolinium
- Known allergy to Albumine
- End-stage organ failure
- Pregnant or breastfeeding women
- Women of childbearing age without effective contraception during the study
- Patient under judicial protection, guardianship, or curatorship
- Previous treatment with ALOFISEL®
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Toulouse Hospital
Toulouse, France
Actively Recruiting
Research Team
E
Etienne BUSCAIL, MD
CONTACT
L
Louis BSUCAIL, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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