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Study identifier: NCT05974280 Synced from ClinicalTrials.gov · July 29, 2026
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Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells

Condition: Crohn Disease · Anal Fistula  ·  Sponsor: Nantes University Hospital

PhaseN/A
Planned participants20
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 pa…

This description comes directly from the study's public registry record.

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Locations (1)

CHU NantesNantes, Nantes, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT05974280