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Taking people in FrancePhase 1/2

Tests donor stem cell injections for Crohn's perianal fistulas after standard care

Tests donor fat-derived stem cells injected into fistulas in adults with Crohn's disease.

Key facts

Who runs it
University Hospital, Toulouse
Where
Toulouse, FranceSee the site
Trial code
Registry title
Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula
Status
Recruiting
Phase
Phase 1/2
People taking part
9 people, planned
Started
12 Mar 2025
Expected to end
Sept 2027
Type of study
Interventional
Treatments tested
  • AdMSC (CellReady®)
Record updated
24 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who have a complex perianal fistula that did not heal after standard treatment, while the bowel disease itself is under control.

Age
18 years or older
Sex
All sexes can join
Disease stage
Complex long-lasting perianal fistula with a maximum of two internal openings and three external openings. Bowel disease controlled (Harvey-Bradshaw score of 8 or less, diagnosed more than 3 months ago). Colonoscopy less than a year old with no ulcer in the rectum.
Earlier treatment
Must have had drainage with setons plus anti-TNFα treatment and not improved after 6 months. Must not have been treated with ALOFISEL® before.

Main reasons for not taking part

  • Positive QuantiFERON test
  • Transplanted organ
  • Cancer in the last five years or lympho-proliferative disease
  • Ongoing bacterial or viral infection
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient previously treated with ALOFISEL®
  • History of cancer in the last five years or lympho-proliferative disease,
  • Persistent bacterial or viral infection,
  • Known allergy to Gadolinium,
  • Known allergy to Albumine,
  • End-stage organ failure,
  • Women of childbearing age without effective contraception throughout the duration of the study,
  • Refusal of the patient to participate in the study,
  • Positive QuantiFERON test,
  • Patient with transplanted organ,
  • Patient with a contraindication to MRI,
  • Pregnant or breastfeeding women,
  • Patient under judicial protection, under guardianship or curatorship

Where in France

  • Toulouse HospitalToulouse, FranceContact: Etienne BUSCAIL, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • AdMSC (CellReady®)Treatment being tested

    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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula:a Phase I/II Clinical Study
Plain-language title
Tests donor stem cell injections for Crohn's perianal fistulas after standard careGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
24 December 2025