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

Toulouse University Hospital

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Crohn Disease

Treatments

Drug: AdMSC (CellReady®)

Study type

Interventional

Funder types

Other

Identifiers

NCT06636032

RC31/13/7030

Details and patient eligibility

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.

Full description

The injection of adipose stromal cells is currently evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischemia, osteoarthritis, systemic slerosis...). Immunoregulatory and anti-inflammatory properties of AdMSC's are responsible for accelerating healing and represents an innovative approach to treat 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 AdMSC (CellReady®) into the fistula.

Different doses of AdMSC will be tested for a dose escalation (5.10*7 and 10.10*7 cells) and injected in the in the wall of the fistula.

Enrollment

9 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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®