Crohn DiseaseCHAZAMNCT05974280
Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
An observational study of Crohn Disease and Anal Fistula, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Anal Fistula
- What is being tested?
- Alofisel and Fat stem cell
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2024to 2 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population with Crohn's disease coming to the digestive surgery department of the CHU in Nantes for perianal surgery
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes, Nantes, 44000
Alexandra Poinas, PhD, 0603197295, alexandra.poinas@chu-nantes.fr
About this study
Official title: Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
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.
Read more
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.
Read the detailed description
The trial will be made available to patients who are scheduled for perianal surgery with ALOFISEL® or backup (fat injection). The history and signs of perianal fistula will be noted if the patient doesn't object.
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
- Crohn Disease, Anal Fistula
- Being tested
- Alofisel, Fat stem cell
- Medical subject headings
- Crohn Disease, Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlofiselDrug
Also called mesenchymal stem cells
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 cellDrug
Also called Fat graft
mesenchymal stem cells from adipose (fat) tissue injection
| Study group | Role | What they receive |
|---|---|---|
| Alofisel group (routine care) | The patient receives Alofisel injection as in routine care Receives: Drug: Alofisel | |
| Autologous fat injection (routine care) | The back-up patient receives autologous fat stem cells injection as in routine care Receives: Drug: Fat stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start2 Jan 2024
- Primary completion2 Jan 2025
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974280
- Sponsor's protocol ID
- AP_CHAzAM_ED_001
- Acronym
- CHAZAM
- Status last verified
- Jun 2026
- First submitted
- 26 Jul 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
- ClinicalTrials.gov ID
- NCT05974280
- Acronym / sponsor ID
- CHAZAM / AP_CHAzAM_ED_001
- Conditions
- Crohn Disease, Anal Fistula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial will be made available to patients who are scheduled for perianal surgery with ALOFISEL® or backup (fat injection). The history and signs of perianal fistula will be noted if the patient doesn't object.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alofisel group (routine care) | – | Drug: AlofiselThe patient receives Alofisel injection as in routine care |
| Autologous fat injection (routine care) | – | Drug: Fat stem cellThe back-up patient receives autologous fat stem cells injection as in routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with Crohn's disease coming to the digestive surgery department of the CHU in Nantes for perianal surgery
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlofiselAlso: mesenchymal stem cellsAlofisel 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 | Alofisel group (routine care) |
| Fat stem cellAlso: Fat graftmesenchymal stem cells from adipose (fat) tissue injection | Drug | Autologous fat injection (routine care) |
Primary outcome
Comparing the efficacy of Alofisel treatment versus fat grafting in Crohn's disease complex perianal fistulae
Time frame: 1 month after the surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Anal Fistula, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the efficacy of Alofisel treatment versus fat grafting in Crohn's disease complex perianal fistulae (time frame: 1 month after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.