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

NCT06636032 | Recruiting Phase 1 DMC

• 1 other identifier: RC31/13/7030
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease

Keywords

Crohn's disease; perianal fistula; regenerative medicine; immunomodulation; allogeneic adipose-derived stem cell

Outcome Measures

Primary Outcomes (3)

• adverse events of grade ≥ 2 at 6 months

  Number of adverse events of grade ≥ 2 related to the experimental treatment (CellReady®) or related to surgical/medical procedures,

  6 months after injection

• Efficacy of AdMSC by clinical evaluation at 6 months

  This evaluation will be measured by the presence or absence of flow through the internal or external orifice see in anoscopy and through the external orifice

  6 months after injection

• Efficacy of AdMSC by radiological evaluation at 6 months

  This evaluation will be measured by disappearance of fistula tract or fistula tract present but inactive.

  6 months after injection

Secondary Outcomes (11)

• Safety at 1 and 3 and 6 months

  1, 3 and 6 months after injection

• Efficacy of AdMSC by clinical evaluation 1 and 3 months

  1 and 3 months after injection

• Efficacy of AdMSC by biological evaluation

  1, 3 and 6 months after injection

• Change from Baseline in quality of life

  1, 3 and 6 months after injection

• Change from Baseline in disease activity

  1, 3 and 6 months after injection

Study Arms (1)

AdMSC (CellReady®)

EXPERIMENTAL

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

Drug: AdMSC (CellReady®)

Interventions

AdMSC (CellReady®) DRUG

At day 0, patients will have AdMSC injections. Patients will be followed-up for 6 months

Also known as: AdMSC

AdMSC (CellReady®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse Hospital

Toulouse, France

RECRUITING

Related Publications (1)

• Buscail E, Gilletta de Saint Joseph C, Lebrin M, Frument I, Gross F, Bournet B, Buscail L, Culetto A, Mokrane F, Delchier MC, Quelven I, Daguzan C, Pugnet G, Duffas JP, Ghouti L, Philis A, Carrere N, Lepage B, Le Cosquer G. Rationale and design of the AlloFIST trial: a phase I/IIa study to evaluate dose escalation of allogeneic adipose-derived stroma/stem cells for the treatment of Crohn's fistula. BMJ Open. 2025 Dec 29;15(12):e104517. doi: 10.1136/bmjopen-2025-104517.

  PMID: 41469061 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Etienne BUSCAIL, MD

  Toulouse Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne BUSCAIL, MD

CONTACT

05 61 32 23 73; buscail.e@chu-toulouse.fr

Louis BSUCAIL, MD

CONTACT

05 61 32 33 98; buscail.l@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: March 12, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)