Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
NCT ID: NCT05974280
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2024-01-02
2025-06-30
Brief Summary
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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.
Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Alofisel group (routine care)
The patient receives Alofisel injection as in routine care
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
Autologous fat injection (routine care)
The back-up patient receives autologous fat stem cells injection as in routine care
Fat stem cell
mesenchymal stem cells from adipose (fat) tissue injection
Interventions
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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
Fat stem cell
mesenchymal stem cells from adipose (fat) tissue injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients hypersensitive to the product, bovine serum or any of the excipients of Alofisel
* Vulnerable persons: deprived of liberty, under guardianship, under curatorship, etc.
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU Nantes
Nantes, , France
Countries
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Facility Contacts
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Alexandra Poinas, PhD
Role: primary
Other Identifiers
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AP_CHAzAM_ED_001
Identifier Type: -
Identifier Source: org_study_id