NCT05974280 Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
| NCT ID | NCT05974280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2025-01-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-01-02 with a primary completion date of 2025-01-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT05974280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05974280 currently recruiting?
Yes, NCT05974280 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nantes University Hospital to inquire about joining.
Where is the NCT05974280 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT05974280 clinical trial?
NCT05974280 is sponsored by Nantes University Hospital. The trial plans to enroll 20 participants.