Crohn's Disease and Colitis Trial, Recruiting (NCT05974280)

Crohn's Disease and Colitis Trial, Recruiting NCT05974280 Sponsor: Nantes University Hospital Condition: Crohn's Disease and Colitis

Printed from Voxsanity (voxsanity.com.au) — NCT05974280 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Crohns Disease And Colitis

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 have a complex anal fistula (an abnormal tunnel near the back passage that is difficult to treat)
Your Crohn's disease in the gut is inactive or only mildly active, and you are receiving standard treatment or a biological therapy (a type of medication that targets the immune system)
A scan (MRI) has shown that the fistula is draining properly
Your fistula has no more than two internal openings and three external openings
The fistula is still present even after the internal opening(s) have been closed

Who may not be able to join:

Women who are pregnant or currently breastfeeding
People who have a known allergy or sensitivity to the study treatment (Alofisel), bovine (cow-derived) serum, or any of its ingredients
People who are considered vulnerable in a legal sense, such as those detained, under guardianship, or under legal protection orders (confirm with trial site)

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

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT05974280

Sponsor: Nantes University Hospital

Phase: Not Applicable

Status: Recruiting

Condition: Crohn's Disease and Colitis

More information: https://clinicaltrials.gov/study/NCT05974280

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have a complex anal fistula (an abnormal tunnel near the back passage that is difficult to treat)
Your Crohn's disease in the gut is inactive or only mildly active, and you are receiving standard treatment or a biological therapy (a type of medication that targets the immune system)
A scan (MRI) has shown that the fistula is draining properly
Your fistula has no more than two internal openings and three external openings
The fistula is still present even after the internal opening(s) have been closed

Who may not be able to join:

Women who are pregnant or currently breastfeeding
People who have a known allergy or sensitivity to the study treatment (Alofisel), bovine (cow-derived) serum, or any of its ingredients
People who are considered vulnerable in a legal sense, such as those detained, under guardianship, or under legal protection orders (confirm with trial site)

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 22 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Nantes University Hospital

Registry

ClinicalTrials.gov

Start date

2 January 2024

Est. completion

2 January 2025

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Comparing the efficacy of Alofisel treatment versus fat grafting in Crohn's disease complex perianal fistulae

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