Donor fat-derived stem cell injections for complex perianal Crohn's fistulas
Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula:a Phase I/II Clinical Study
This treatment will try injecting donor adipose-derived stem cells into complex perianal fistulas in adults with Crohn's disease who did not improve after drainage and biologic therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06636032 on ClinicalTrials.gov |
What this trial studies
This phase I/II, open-label dose-escalation study delivers allogeneic adipose-derived stromal/stem cells (CellReady®) directly into the wall of complex perianal fistulas. Two escalating dose cohorts (5×10^7 and 1×10^8 cells) will receive local injections with safety and early healing outcomes recorded over follow-up. Eligible adults must have controlled luminal Crohn's disease, a colonoscopy within one year without rectal ulcers, and persistent complex fistulas after at least six months of seton drainage plus anti-TNF therapy. Key exclusions include positive QuantiFERON, organ transplant, recent cancer, or active systemic infection, and all participants will be treated and followed at Toulouse Hospital.
Who should consider this trial
Good fit: Adults with Crohn's disease who have complex chronic perianal fistulas (up to two internal and three external openings), controlled intestinal disease, and documented failure of seton drainage plus anti-TNF therapy for at least six months.
Not a fit: Patients with active systemic or persistent infections, positive QuantiFERON, organ transplants, recent cancers, uncontrolled intestinal disease, or more extensive fistula anatomy are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the injections could promote fistula healing and reduce inflammation, offering an option for patients who failed standard treatments.
How similar studies have performed: Similar allogeneic adipose-derived mesenchymal cell therapies (for example darvadstrocel/Alofisel) have shown benefit for Crohn's perianal fistulas in prior trials, so this approach has clinical precedent.
Eligibility criteria
Show full inclusion / exclusion criteria
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®
Where this trial is running
Toulouse
- Toulouse Hospital — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Etienne BUSCAIL, MD — Toulouse Hospital
- Study coordinator: Etienne BUSCAIL, MD
- Email: buscail.e@chu-toulouse.fr
- Phone: 05 61 32 23 73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.