An observational study in Crohn Disease and Anal Fistula, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Nantes University Hospital · Observational
Among 316 studies in Crohn Disease with a site in France — 80 open to participants now, 104 under way, 29 of them phase 3. Crohn Disease · France.
Among the 316 studies in Crohn Disease with a site in France, this one is the 83rd largest by planned enrollment of the 87 observational ones, is one of 23 that started in 2024, is one of 88 observational ones, reaches primary completion later than 7 of the 103 other live ones, and was the 250th registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 20 is below the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →80 of the 316 studies in Crohn Disease with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →316 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 23 started in 2024.
Median enrollment 147 across the 228 interventional studies, 240 across the 87 observational. Of the 194 that completed or were terminated, 78 (40%) have results posted.
150 of 316 have an industry lead sponsor. The 10 most frequent:
Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Nantes University Hospital has 5 studies filed under Crohn Disease — fewer than ten, so there is no comparison to draw.
33 of the studies in Crohn Disease with a site in France that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04777656Phase 3Assistance Publique - Hôpitaux de ParisUse of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. | 2026-11 |
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT04997733Phase 3Assistance Publique - Hôpitaux de ParisFecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal | 2027-05-22 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT06227910Phase 3TakedaA Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease | 2027-06-08 |
Among the 316 studies in Crohn Disease with a site in France, from their registry updates:
One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas with stem cells.
The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of difficult perianal Crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy.
This brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed.
Only one of the two patients receives therapy; the other serves as the backup patient. By doing this, another "back-up" patient who might receive no care at all is avoided.
An developing alternate approach to allogeneic ADSC injection for the treatment of complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat grafts have been the subject of in-depth research. They are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities.
We would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of CD.
The trial will be made available to patients who are scheduled for perianal surgery with ALOFISEL® or backup (fat injection). The history and signs of perianal fistula will be noted if the patient doesn't object.
Two visits that correspond to typical follow-up visits for patients will be noted:
Visit following surgery: fistula clinical evaluation, analgesic use, etc. and six months after : clinical assessment, MRI
Population with Crohn's disease coming to the digestive surgery department of the CHU in Nantes for perianal surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient receives Alofisel injection as in routine care
Drug: Alofisel
The back-up patient receives autologous fat stem cells injection as in routine care
Drug: Fat stem cell
Alofisel is made up of 'mesenchymal stem cells' from the fat tissue of a donor. Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease
Also known as: mesenchymal stem cells
mesenchymal stem cells from adipose (fat) tissue injection
Also known as: Fat graft
Comparing the efficacy of Alofisel treatment versus fat grafting in Crohn's disease complex perianal fistulae
At 1 month, the percentage of healing is defined as the clinical closure of the orifice and the lack of pus draining by pressure on the borders of the fistula scar.
Time frame: 1 month after the surgery
Ran from Jan 2024 to primary completion in Jan 2025, 12 months.
Of 231 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's 12 months is below that.
Counting every sponsor, half of 304 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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