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NCT Number: NCT05974280

Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells

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.

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Key information

Conditions

Crohn Disease Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Alofisel

Drug

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

Other names: mesenchymal stem cells

Fat stem cell

Drug

mesenchymal stem cells from adipose (fat) tissue injection

Other names: Fat graft

Primary outcomes

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

    Time frame: 1 month after the surgery

    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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells

Acronym: CHAZAM

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Aug 3, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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