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NCT05974280: CHAZAM
Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
trial testing Alofisel in Crohn Disease in 20 participants. Currently enrolling.
2 January 2025
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 2 January 2024 |
| Primary completion | 2 January 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- Alofisel — full drug profile →
- Fat stem cell — full drug profile →
Conditions studied
- Crohn Disease — all drugs for Crohn Disease →
- Anal Fistula — all drugs for Anal Fistula →
Sponsor
Nantes University Hospital
Who can join
18 and older, any sex, with Crohn Disease or Anal Fistula. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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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.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Systematic review and meta-analysis of the efficacy and safety of stem cell treatment of anal fistulas.
Emile SH, Dourado J, Rogers P, Wignakumar A, et al · · 2025 · cited 5× · PMID 40205247 · DOI 10.1007/s10151-025-03138-y -
Immunomodulatory Mechanisms of Chronic Wound Healing: Translational and Clinical Relevance.
Riaz M, Iqbal MZ, Klar AS, Biedermann T. · · 2025 · cited 1× · PMID 41127507 · DOI 10.1002/mco2.70378
Verify or expand the search:
- PubMed search for NCT05974280
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
- NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
- NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
- NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
Other Nantes University Hospital trials
Trials by the same sponsor.
- NCT07278661 — Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. · Phase 2 · recruiting
- NCT06681363 — Creation of a Biocollection of Patients With Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelod · not yet recruiting
- NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
- NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
- NCT07423481 — Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05974280 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 20 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05974280.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing