Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06636032 Sponsor: University Hospital, Toulouse Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06636032
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be 18 years old or older
  • You must have signed a consent form agreeing to take part in the study
  • You must be covered by a social security/health insurance system
  • You must have Crohn's disease affecting the digestive tract that is considered "controlled" (mild symptoms based on a specific scoring system), diagnosed using clinical, imaging, or tissue tests for more than 3 months
  • You must have had a colonoscopy within the last year that showed no ulcers in the rectum
  • You must have a complex, long-lasting anal fistula (an abnormal tunnel near the back passage) with a limited number of openings (no more than two internal and three external)
  • You must currently be receiving a combined treatment involving surgical drainage tubes and a specific type of medication called anti-TNF therapy, and this treatment must not have worked well enough after 6 months, while your Crohn's disease in the gut itself remains under control

Who may not be able to join:

  • You do not wish to take part in the study
  • You have tested positive for tuberculosis on a specific blood test called QuantiFERON
  • You have had an organ transplant
  • You have been diagnosed with cancer or a blood/lymph system cancer in the last five years
  • You currently have an ongoing bacterial or viral infection
  • You have a medical reason why you cannot have an MRI scan (confirm with trial site)
  • You have a known allergy to Gadolinium (a substance used in MRI scans)
  • You have a known allergy to Albumin (a protein)
  • You have severe, end-stage failure of a major organ (such as the heart, liver, or kidneys)
  • You are currently pregnant or breastfeeding
  • You are a woman who could become pregnant but are not using reliable contraception for the entire duration of the study
  • You are under a form of legal protection or guardianship that affects your ability to consent (confirm with trial site)
  • You have previously been treated with a medicine called ALOFISEL®

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Etienne BUSCAIL, MD, Toulouse Hospital

Phone: 05 61 32 23 73

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
12 March 2025
Est. completion
1 September 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

adverse events of grade ≥ 2 at 6 months; Efficacy of AdMSC by clinical evaluation at 6 months; Efficacy of AdMSC by radiological evaluation at 6 months

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov