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Crohn DiseaseECESMACNCT05177003

Study of the 12-month Efficacy of Stem Cell Injection in Crohn's Disease With Complex Ano-perineal Fistula

An observational study of Crohn Disease and Ano Fistula, run by Fondation Hôpital Saint-Joseph at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Ano-perineal (or ano-rectal) fistulas are a frequent and major complication of Crohn's disease. Indeed, they indicate a greater severity of the disease. In addition, they have a major impact on the quality of life of patients. Finally, these fistulas are difficult to cure, especially when they are complex. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease, Ano Fistula
How many people
27 participants
Where
2 sitesFrance
Study dates
2 Jul 2021to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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: Patient with inactive or minimally active Crohn's disease associated with one or more complex ano-perineal fistula(s) that has not responded to at least one conventional biologic therapy, managed for their fistula(s) by mesenchymal stem cell injection between July 1, 2020 and July 30, 2021 at one of the participating centers.

Who may be able to join

  • Patient whose age ≥ 18 years
  • Patient with inactive or minimally active Crohn's disease associated with one or more complex ano-perineal fistula(s) that has not responded to at least one conventional biologic therapy
  • Patients managed for their fistula(s) by mesenchymal stem cell injection between July 1, 2020 and July 30, 2021 at one of the participating centers
  • Patients who understand the French language

Who cannot join

  • Patients under guardianship or curatorship
  • Minor patients
  • Pregnant women
  • Patient deprived of liberty
  • Patient under court protection
  • Patients who object to the use of their data for this research
Show all 10Show fewer
  • Patients with a simple anal fistula
  • Patients with anorecto-vaginal fistula
  • Patients with anal canal stenosis that cannot be crossed by the index finger
  • Patients who have not previously received medical treatment (biotherapy +/- immunosuppressant)

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

  • CHU de Rennes

    Rennes

Other trials in France

About this study

Ano-perineal (or ano-rectal) fistulas are a frequent and major complication of Crohn's disease. Indeed, they indicate a greater severity of the disease. In addition, they have a major impact on the quality of life of patients. Finally, these fistulas are difficult to cure, especially when they are complex. Indeed, medical treatment with anti-TNF drugs can only cure them in one third of cases. Various obturation treatments have been proposed in addition to medical treatment such as advancement flap, injection of biological glue, placement of a plug, intersphincter ligation of the fistulous path or laser but with still insufficient healing rates.

The injection of mesenchymal stem cells of adipose origin was first proposed for this indication in 2003. Since then, numerous studies have been published on the subject. Most importantly, an international multicenter randomized double-blind phase 3 controlled trial demonstrated the superiority of allogeneic stem cells over placebo with a therapeutic effect maintained at one year follow-up. The trial involved selected patients with Crohn's disease and one or more complex ano-perineal fistulas refractory to conventional treatments. This treatment has a high cost and its practical modalities are constraining (manufacturing, delivery, constrained time between the factory and the injection). However, this study is the first to have demonstrated in such a rigorous way the effectiveness of a local treatment on complex ano-perineal fistulas of Crohn's disease. These allogeneic mesenchymal stem cells have therefore been granted marketing authorization in Europe and have been commercialized in several European countries including France during the summer of 2020 under the trade name ALOFISEL®. They are indicated for complex ano-perineal fistulas that have not responded to at least one conventional biological treatment, in the context of inactive or less active Crohn's disease.

The main objective of the study is to evaluate the rate of "deep" remission (i.e. clinical and radiological) at 12 months of follow-up in the first patients treated in France with ALOFISIEL® after its marketing. The evaluation is performed at 12 months because it seems that the result is consolidated after this period.

Medical subject headings
Crohn Disease, Rectal Fistula

What is being measured

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

  1. Deep remission rates

    This outcome corresponds to the Rate of patients in deep remission at 12 months defined by the combination of:

    • absence of pain and oozing
    • closure of the secondary orifice(s) with the absence of discharge on digital pressure
    • absence of abscesses
    • absence of a collection of more than 20 mm on MRI.

    Measured: Month 12

Secondary outcomes (3)

  1. 12-month clinical remission rate only

    This outcome corresponds to the rate of patients in clinical remission alone at 12 months defined by the combination

    • an absence of pain and oozing
    • closure of the secondary orifice(s) with the absence of discharge on digital pressure
    • absence of abscesses

    Measured: Month 12

  2. Primary clinical failure rate

    This outcome corresponds to the rate of patients with primary treatment failure defined as non-closure of secondary orifice(s) with persistent flow on digital pressure at 3-month follow-up.

    Measured: Month 3

  3. Evolution of the severity of the disease at 12 months

    This outcome corresponds to the complication rates and types at 12 months.

    Measured: Month 12

Timeline

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

  1. First posted4 Jan 2022
  2. Study start2 Jul 2021
  3. Primary completion2 Sep 2022
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Cross-sectional
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05177003
Sponsor's protocol ID
ECESMAC
Acronym
ECESMAC
Status last verified
Oct 2022
First submitted
31 Dec 2021
Last updated
1 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Alam A, Lin F, Fathallah N, Pommaret E, Aubert M, Lemarchand N, Abbes L, Spindler L, Portal A, de Parades V. FiLaC(R) and Crohn's disease perianal fistulas: a pilot study of 20 consecutive patients. Tech Coloproctol. 2020 Jan;24(1):75-78. doi: 10.1007/s10151-019-02134-3. Epub 2019 Dec 31.

    PubMed 31893324

  • Ciccocioppo R, Klersy C, Leffler DA, Rogers R, Bennett D, Corazza GR. Systematic review with meta-analysis: Safety and efficacy of local injections of mesenchymal stem cells in perianal fistulas. JGH Open. 2019 Feb 13;3(3):249-260. doi: 10.1002/jgh3.12141. eCollection 2019 Jun.

    PubMed 31276044

  • Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.

    PubMed 12756590

  • Mahadev S, Young JM, Selby W, Solomon MJ. Quality of life in perianal Crohn's disease: what do patients consider important? Dis Colon Rectum. 2011 May;54(5):579-85. doi: 10.1007/DCR.0b013e3182099d9e.

    PubMed 21471759

  • Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24.

    PubMed 29277560

  • Brochard C, Rabilloud ML, Hamonic S, Bajeux E, Pagenault M, Dabadie A, Gerfaud A, Viel JF, Tron I, Robaszkiewicz M, Bretagne JF, Siproudhis L, Bouguen G; Groupe ABERMAD. Natural History of Perianal Crohn's Disease: Long-term Follow-up of a Population-Based Cohort. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e102-e110. doi: 10.1016/j.cgh.2020.12.024. Epub 2020 Dec 24.

    PubMed 33359730

  • Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011 Apr;106(4):644-59, quiz 660. doi: 10.1038/ajg.2011.73. Epub 2011 Mar 15.

    PubMed 21407183

  • Stellingwerf ME, van Praag EM, Tozer PJ, Bemelman WA, Buskens CJ. Systematic review and meta-analysis of endorectal advancement flap and ligation of the intersphincteric fistula tract for cryptoglandular and Crohn's high perianal fistulas. BJS Open. 2019 Jan 21;3(3):231-241. doi: 10.1002/bjs5.50129. eCollection 2019 Jun.

    PubMed 31183438

  • Grimaud JC, Munoz-Bongrand N, Siproudhis L, Abramowitz L, Senejoux A, Vitton V, Gambiez L, Flourie B, Hebuterne X, Louis E, Coffin B, De Parades V, Savoye G, Soule JC, Bouhnik Y, Colombel JF, Contou JF, Francois Y, Mary JY, Lemann M; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif. Fibrin glue is effective healing perianal fistulas in patients with Crohn's disease. Gastroenterology. 2010 Jun;138(7):2275-81, 2281.e1. doi: 10.1053/j.gastro.2010.02.013. Epub 2010 Feb 20.

    PubMed 20178792

  • Senejoux A, Siproudhis L, Abramowitz L, Munoz-Bongrand N, Desseaux K, Bouguen G, Bourreille A, Dewit O, Stefanescu C, Vernier G, Louis E, Grimaud JC, Godart B, Savoye G, Hebuterne X, Bauer P, Nachury M, Laharie D, Chevret S, Bouhnik Y; Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif [GETAID]. Fistula Plug in Fistulising Ano-Perineal Crohn's Disease: a Randomised Controlled Trial. J Crohns Colitis. 2016 Feb;10(2):141-8. doi: 10.1093/ecco-jcc/jjv162. Epub 2015 Sep 8.

    PubMed 26351393

  • van Praag EM, Stellingwerf ME, van der Bilt JDW, Bemelman WA, Gecse KB, Buskens CJ. Ligation of the Intersphincteric Fistula Tract and Endorectal Advancement Flap for High Perianal Fistulas in Crohn's Disease: A Retrospective Cohort Study. J Crohns Colitis. 2020 Jul 9;14(6):757-763. doi: 10.1093/ecco-jcc/jjz181.

    PubMed 31696918

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn Disease and Ano Fistula, run by Fondation Hôpital Saint-Joseph at 2 sites 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deep remission rates (time frame: Month 12). 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 NCT05177003, which also lists 11 linked publications.

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 1 Nov 2022.

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