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Cx601
Cx601 is an allogeneic adipose-derived mesenchymal stem cell therapy that promotes tissue repair and immune modulation in the colon.
Cx601 is an allogeneic adipose-derived mesenchymal stem cell therapy that promotes tissue repair and immune modulation in the colon. Used for Complex perianal fistulas in patients with Crohn's disease.
At a glance
| Generic name | Cx601 |
|---|---|
| Sponsor | Tigenix S.A.U. |
| Drug class | Allogeneic mesenchymal stem cell therapy |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Immunology |
| Phase | Phase 3 |
Mechanism of action
Cx601 consists of expanded allogeneic mesenchymal stem cells derived from adipose tissue, administered locally via intralesional injection into fistula tracts in Crohn's disease. These cells are believed to promote healing through anti-inflammatory effects, tissue regeneration, and modulation of the local immune microenvironment, reducing fistula closure failure rates.
Approved indications
- Complex perianal fistulas in patients with Crohn's disease
Common side effects
- Injection site pain or discomfort
- Fistula-related abscess
- Infection at injection site
Key clinical trials
- A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula (PHASE4)
- A Survey of Darvadstrocel in People With Crohn's Disease
- A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease (PHASE3)
- Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula (PHASE3)
- Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (PHASE3)
- Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease (PHASE3)
- Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease
- Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cx601 CI brief — competitive landscape report
- Cx601 updates RSS · CI watch RSS
- Tigenix S.A.U. portfolio CI