Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula
Recruiting · NCT06636032 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Patients over 18 years old,
- Patients who signed the informed consent,
- Patient affiliated to a social security system,
- Controlled luminal Crohn's disease characterized by an Harvey-Bradshaw score less or equal than 8 and diagnosed on clinical, endoscopic, histological and/or radiological criteria for more than 3 months,
- Colonoscopy less than a year old without ulcer in the rectum,
- Presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports,
- Patient treated with a combined treatment (drainage on setons + anti-TNFα) and who failed conventional treatment after 6 months and whose intraluminal disease (intestinal damage) is controlled
Exclusion criteria
- Refusal of the patient to participate in the study,
- Positive QuantiFERON test,
- Patient with transplanted organ,
- History of cancer in the last five years or lympho-proliferative disease,
- Persistent bacterial or viral infection,
- Patient with a 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 throughout the duration of the study,
- Patient under judicial protection, under guardianship or curatorship.
- Patient previously treated with ALOFISEL®
Where it is running
1 location listed.
- Toulouse Hospital - Toulouse, France