Donor fat-derived stem cell injections for complex perianal Crohn's fistulas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Microencapsulated Propionate vs Butyrate for Crohn's Disease in Remission

  This study tests whether microencapsulated sodium propionate can favorably alter the gut microbiota and inflammation in adults with Crohn’s disease, compared with sodium butyrate.

  Recruiting University of Padova · Padova · NCT07883044

• Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

  This study tests whether risankizumab can help people with Crohn’s disease who have draining perianal fistulas not responding to other treatments.

  Recruiting Phase 4 Hyogo Medical University · Nishinomiya and 3 other locations · NCT07872449

• Intestinal ultrasound-guided management for inflammatory bowel disease

  This study tests if adding point-of-care intestinal ultrasound at every visit changes treatment decisions for adults with Crohn’s disease or ulcerative colitis undergoing disease assessment.

  Recruiting Mahidol University · Bangkok · NCT07775352

• Laser-based sizing of GI lesions during endoscopies

  This study tests whether the AccuMeasure laser tool gives more accurate and reliable lesion size measurements during colonoscopies for adults with colon polyps or Crohn’s disease than traditional endoscopic estimates.

  Recruiting Centre hospitalier de l'Université de Montréal (CHUM) · Montreal, Quebec · NCT07770425

• A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis

  A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.

  Recruiting Catholic University of the Sacred Heart · Roma, RM · NCT07724990

• Claudin-2 Immunostaining to Detect Active or Inactive Inflammation in IBD Biopsies

  This study tests whether staining for Claudin-2 in intestinal biopsy samples can help identify active vs. inactive inflammation in people with ulcerative colitis or Crohn's disease.

  Recruiting IRCCS Policlinico S. Donato · San Donato Milanese, Mi · NCT07710287

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.