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

Last updated: December 23, 2025
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

AdMSC (CellReady®)

Clinical Study ID

NCT06636032
RC31/13/7030
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 orequal than 8 and diagnosed on clinical, endoscopic, histological and/or radiologicalcriteria 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 portsand three external ports,

  • Patient treated with a combined treatment (drainage on setons + anti-TNFα) and whofailed conventional treatment after 6 months and whose intraluminal disease (intestinal damage) is controlled

Exclusion

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 ofthe study,

  • Patient under judicial protection, under guardianship or curatorship.

  • Patient previously treated with ALOFISEL®

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: AdMSC (CellReady®)
Phase: 1/2
Study Start date:
March 12, 2025
Estimated Completion Date:
September 30, 2027

Study 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 (5.107 and 10.107 cells) and injected in the in the wall of the fistula.

Connect with a study center

  • Toulouse Hospital

    Toulouse,
    France

    Site Not Available

  • Toulouse Hospital

    Toulouse 2972315,
    France

    Active - Recruiting

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