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

NCT ID: NCT06636032

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2027-09-30

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.

Detailed Description

The injection of adipose stromal cells is currently evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischemia, osteoarthritis, systemic slerosis...). Immunoregulatory and anti-inflammatory properties of AdMSC's are responsible for accelerating healing and represents an innovative approach to treat 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 AdMSC (CellReady®) into the fistula.

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.

Conditions

Crohn Disease

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AdMSC (CellReady®)

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

Group Type: EXPERIMENTAL

AdMSC (CellReady®)

Intervention Type: DRUG

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

Interventions

AdMSC (CellReady®)

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

Intervention Type: DRUG

Other Intervention Names

AdMSC

Eligibility 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®

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne BUSCAIL, MD

Role: PRINCIPAL_INVESTIGATOR

Toulouse Hospital

Locations

Toulouse Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Etienne BUSCAIL, MD

Role: CONTACT

Phone: 05 61 32 23 73

Email: buscail.e@chu-toulouse.fr

Louis BSUCAIL, MD

Role: CONTACT

Phone: 05 61 32 33 98

Email: buscail.l@chu-toulouse.fr

Facility Contacts

Etienne BUSCAIL, MD

Role: primary

Other Identifiers

RC31/13/7030

Identifier Type: -

Identifier Source: org_study_id