RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula

Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula:a Phase I/II Clinical Study

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Patients over 18 years old, - Patients who signed the willing to sign a consent form, - 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 Who Should NOT Join This Trial: - 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® Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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®

Treatments Being Tested

DRUG

AdMSC (CellReady®)

At day 0, patients will have AdMSC injections. Patients will be followed-up for 6 months

Locations (1)

Toulouse Hospital

Toulouse, France