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

NCT05974280 | Recruiting

• 1 other identifier: AP_CHAzAM_ED_001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease; Anal Fistula

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after the surgery

Study Arms (2)

Alofisel group (routine care)

The patient receives Alofisel injection as in routine care

Drug: Alofisel

Autologous fat injection (routine care)

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

Drug: Fat stem cell

Interventions

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

Also known as: mesenchymal stem cells

Alofisel group (routine care)

Fat stem cell DRUG

mesenchymal stem cells from adipose (fat) tissue injection

Also known as: Fat graft

Autologous fat injection (routine care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population with Crohn's disease coming to the digestive surgery department of the CHU in Nantes for perianal surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, 44000, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Rectal Fistula

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: January 2, 2024
• Primary Completion: January 2, 2025
• Study Completion: June 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

FR (1)