NCT06636032RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 8 Oct 2024
- Start date
- 12 Mar 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Crohn's disease
- NCT number
- NCT06636032
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 9
- From 12 Mar 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient previously treated with ALOFISEL®
Other illness
- 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,
Age
- Women of childbearing age without effective contraception throughout the duration of the study,
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toulouse Hospital Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.