Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Population with Crohn's disease coming to the digestive surgery department of the CHU in Nantes for perianal surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Alofisel
DrugAlofisel 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
Fat stem cell
Drugmesenchymal stem cells from adipose (fat) tissue injection
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Alofisel group (routine care)1 intervention
Group B: Autologous fat injection (routine care)1 intervention
Trial outcomes
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.
Time frame
1 month after the surgerySponsors and contacts
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Source ClinicalTrials.gov