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Compares two stem cell treatments for anal fistulas in Crohn's disease

Compares Alofisel and fat-derived stem cells in adults with Crohn's anal fistulas.

Key facts

Who runs it
Nantes University Hospital
Where
Nantes, FranceSee the site
Trial code
Registry title
Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
Status
Recruiting
People taking part
20 people, planned
Started
2 Jan 2024
Expected to end
2 Jun 2027
Type of study
Observational, 2 groups
Treatments tested
  • Alofisel
  • Fat stem cell
Record updated
24 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who have a complex anal fistula. It compares Alofisel with injected stem cells from the person's own fat.

Age
18 years or older
Sex
All sexes can join
Disease stage
Complex anal fistula. Crohn's disease in the bowel must be inactive or only slightly active. MRI must show good drainage. At most two internal and three external openings. The fistula persists despite the internal opening(s) closing.
Earlier treatment
Must be on conventional treatment or biotherapy for Crohn's disease.

Main reasons for not taking part

  • Pregnant or breast-feeding women
  • Allergy to Alofisel, bovine serum or any of the other ingredients of Alofisel
  • Vulnerable persons, such as people deprived of liberty or under guardianship

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Complex anal fistula with the following criteria: - Inactive/slightly active luminal Crohn's disease under conventional treatment or biotherapy MRI has demonstrated effective drainage. Maximum of two internal orifices and three external orifices; persists despite internal orifice(s) closing

Who cannot take part

  • Patients hypersensitive to the product, bovine serum or any of the excipients of Alofisel
  • Pregnant or breast-feeding women
  • Vulnerable persons: deprived of liberty, under guardianship, under curatorship, etc

Where in France

  • CHU NantesNantes, FranceContact: Alexandra Poinas, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 2 groups in the trial

  • Alofisel group (routine care)

    The patient receives Alofisel injection as in routine care

    Treatment: Alofisel

  • Autologous fat injection (routine care)

    The back-up patient receives autologous fat stem cells injection as in routine care

    Treatment: Fat stem cell

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
Plain-language title
Compares two stem cell treatments for anal fistulas in Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 June 2026