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

NCT05974280 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-12-27

No results posted yet for this study

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

Interventions

DRUG

Alofisel

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

DRUG

Fat stem cell

mesenchymal stem cells from adipose (fat) tissue injection

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-01-02
Completion
2025-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974280 on ClinicalTrials.gov