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Crohn DiseasePhase 1/2ALLOFISTNCT06636032

Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula

A Phase 1/2 study testing AdMSC (CellReady®) in people with Crohn Disease, run by University Hospital, Toulouse at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Perianal fistulas are in the forefront (42 to 72, 4%) of morbid complication of Crohn's disease, affecting nearly one- third of patients and complicating abscesses in 35-48% of cases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
AdMSC (CellReady®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteFrance
Study dates
12 Mar 2025to Sep 2027
Phase
Phase 1/2
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

Who may be able to join

  • Patients over 18 years old,
  • Patients who signed the informed consent,
  • Patient affiliated to a social security system,
  • Controlled luminal Crohn's disease characterized by an Harvey-Bradshaw score less or equal than 8 and diagnosed on clinical, endoscopic, histological and/or radiological criteria for more than 3 months,
  • Colonoscopy less than a year old without ulcer in the rectum,
  • Presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports,
  • Patient treated with a combined treatment (drainage on setons + anti-TNFα) and who failed conventional treatment after 6 months and whose intraluminal disease (intestinal damage) is controlled

Who cannot join

  • Refusal of the patient to participate in the study,
  • Positive QuantiFERON test,
  • Patient with transplanted organ,
  • History of cancer in the last five years or lympho-proliferative disease,
  • Persistent bacterial or viral infection,
  • Patient with a contraindication to MRI,
Show all 13Show fewer
  • Known allergy to Gadolinium,
  • Known allergy to Albumine,
  • End-stage organ failure,
  • Pregnant or breastfeeding women,
  • Women of childbearing age without effective contraception throughout the duration of the study,
  • Patient under judicial protection, under guardianship or curatorship.
  • Patient previously treated with ALOFISEL®

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Etienne BUSCAIL, MD contact

05 61 32 23 73 ext. +33

buscail.e@chu-toulouse.fr

Louis BSUCAIL, MD contact

05 61 32 33 98 ext. +33

buscail.l@chu-toulouse.fr

France1 site, 1 recruiting

  • Toulouse Hospital

    Toulouse

    Etienne BUSCAIL, MD, 05 61 32 23 73 ext. +33, buscail.e@chu-toulouse.fr

    Recruiting

Other trials in France

About this study

Official title: Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula:a Phase I/II Clinical Study

Perianal fistulas are in the forefront (42 to 72, 4%) of morbid complication of Crohn's disease, affecting nearly one- third of patients and complicating abscesses in 35-48% of cases. The current treatment is based on the combination of drainage (proctologic and surgical), and biologics techniques, but the failure rate varies from 30 to 80%. Actually, innovative cell therapy procedures are validated by Cell-Easy with the use of allogenic mesenchymal stem cells for the immunomodulatory, anti-inflammatory, angiogenic and trophic properties (CellReady®) and represent a promising option in the treatment of perianal fistulas associated with Crohn's disease. This phase I/II study is designed to evaluate the treatment of complex perianal fistulas associated with Crohn's disease, after failure of conventional treatment by injection of allogeneic cultured adipose-derived stromal cell (AdMSC) into the fistula.

Read the detailed description

The injection of adipose stromal cells is currently evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischemia, osteoarthritis, systemic slerosis...). Immunoregulatory and anti-inflammatory properties of AdMSC's are responsible for accelerating healing and represents an innovative approach to treat perianal fistulas associated with Crohn's disease.

This phase I/II study is designed to evaluate the treatment of complex perianal fistulas associated with Crohn's disease, after failure of conventional treatment by injection of AdMSC (CellReady®) into the fistula.

Different doses of AdMSC will be tested for a dose escalation (5.10*7 and 10.10*7 cells) and injected in the in the wall of the fistula.

Conditions
Crohn Disease
Being tested
AdMSC (CellReady®)
Keywords
Crohn's disease, perianal fistula, regenerative medicine, immunomodulation, allogeneic adipose-derived stem cell
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdMSC (CellReady®)Drug

    Also called AdMSC

    At day 0, patients will have AdMSC injections. Patients will be followed-up for 6 months

Study groups in NCT06636032
Study groupRoleWhat they receive
AdMSC (CellReady®)ExperimentalDifferent doses of AdMSC will be tested for a dose escalation (5.10*7 and 10.10*7 cells) and injected in the in the wall of the fistula
Receives: Drug: AdMSC (CellReady®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events of grade ≥ 2 at 6 months

    Number of adverse events of grade ≥ 2 related to the experimental treatment (CellReady®) or related to surgical/medical procedures,

    Measured: 6 months after injection

  2. Efficacy of AdMSC by clinical evaluation at 6 months

    This evaluation will be measured by the presence or absence of flow through the internal or external orifice see in anoscopy and through the external orifice

    Measured: 6 months after injection

  3. Efficacy of AdMSC by radiological evaluation at 6 months

    This evaluation will be measured by disappearance of fistula tract or fistula tract present but inactive.

    Measured: 6 months after injection

Secondary outcomes (11)

  1. Safety at 1 and 3 and 6 months

    adverse effects will be assessed

    Measured: 1, 3 and 6 months after injection

  2. Efficacy of AdMSC by clinical evaluation 1 and 3 months

    This evaluation will be measured by the presence or absence of flow through the internal or external orifice see in anoscopy and through the external orifice

    Measured: 1 and 3 months after injection

  3. Efficacy of AdMSC by biological evaluation

    complete blood count , platelets, C-reactive protein (CRP) , liver enzyme profile, Prothrombin level (TP), activated clotting time (ACT), albumin, ferritinemia will be measured in blood samples

    Measured: 1, 3 and 6 months after injection

  4. Change from Baseline in quality of life

    Evaluation of quality of life by CAF QoL

    Measured: 1, 3 and 6 months after injection

  5. Change from Baseline in disease activity

    Evaluation of quality of life by Harvey-Bradshaw Index

    Measured: 1, 3 and 6 months after injection

  6. Change from Baseline in perianal disease activity

    Evaluation by perianal disease activity index (PDAI) . This index evaluate the presence of a fistula, the presence of pain and its impact on activity, the characteristics of the APL, the impact on the sexual activity

    Measured: 1, 3 and 6 months after injection

  7. Change from Baseline in lesions

    Evaluation by Cardiff classifcation . The creation of subclasses of anoperineal lesions allowing the comparison of superimposable groups in therapeutic trials. This classification allows a standardized and precise description of lesions.

    Measured: 1, 3 and 6 months after injection

  8. Change from Baseline in anal incontinence

    Evaluation by Wexner anal incontinence score: score to quickly and simply assess the severity of anal incontinence.

    Measured: 1, 3 and 6 months after injection

  9. Change from Baseline in patient symptoms

    Evaluation by Allan score: score used to assess patient symptoms and assess the impact of treatment on perineal lesions.

    Measured: 1, 3 and 6 months after injection

  10. tryptophan metabolists

    tryptophan metabolists are measured by high pressure liquid chromatography coupled with tandem mass spectrometry

    Measured: 3 and 6 months after injection

  11. faecal microbiota

    faecal microbiota is analysed by Illumina Mi-Seq

    Measured: 3 and 6 months after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2024
  2. Study start12 Mar 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636032
Sponsor's protocol ID
RC31/13/7030
Acronym
ALLOFIST
Status last verified
Dec 2025
First submitted
8 Oct 2024
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Buscail E, Gilletta de Saint Joseph C, Lebrin M, Frument I, Gross F, Bournet B, Buscail L, Culetto A, Mokrane F, Delchier MC, Quelven I, Daguzan C, Pugnet G, Duffas JP, Ghouti L, Philis A, Carrere N, Lepage B, Le Cosquer G. Rationale and design of the AlloFIST trial: a phase I/IIa study to evaluate dose escalation of allogeneic adipose-derived stroma/stem cells for the treatment of Crohn's fistula. BMJ Open. 2025 Dec 29;15(12):e104517. doi: 10.1136/bmjopen-2025-104517.

    PubMed 41469061

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AdMSC (CellReady®) in people with Crohn Disease, run by University Hospital, Toulouse 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 7 inclusion and 13 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 Dec 2025. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Etienne BUSCAIL, MD (05 61 32 23 73 ext. +33, buscail.e@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events of grade ≥ 2 at 6 months (time frame: 6 months after injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636032, which also lists 1 linked publication.

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 Dec 2025.

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