{"id":"cx601","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or discomfort"},{"rate":null,"effect":"Fistula-related abscess"},{"rate":null,"effect":"Infection at injection site"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"Cx601 is an allogeneic adipose-derived mesenchymal stem cell therapy that promotes tissue repair and immune modulation in the colon.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:44:20.517Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Complex perianal fistulas in patients with Crohn's disease"}]},"trialDetails":[{"nctId":"NCT04118088","phase":"PHASE4","title":"A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula","status":"TERMINATED","sponsor":"Takeda","startDate":"2020-12-22","conditions":"Crohn's Disease, Complex Perianal Fistula","enrollment":53},{"nctId":"NCT05113095","phase":"","title":"A Survey of Darvadstrocel in People With Crohn's Disease","status":"RECRUITING","sponsor":"Takeda","startDate":"2021-11-30","conditions":"Crohn's Disease","enrollment":275},{"nctId":"NCT04701411","phase":"PHASE3","title":"A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease","status":"TERMINATED","sponsor":"Takeda","startDate":"2021-06-30","conditions":"Crohn's Disease, Complex Perianal Fistula","enrollment":7},{"nctId":"NCT04075825","phase":"PHASE3","title":"Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula","status":"COMPLETED","sponsor":"Takeda","startDate":"2019-11-05","conditions":"Crohn's Disease, Complex Perianal Fistula","enrollment":150},{"nctId":"NCT03279081","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Tigenix S.A.U.","startDate":"2017-09-15","conditions":"Crohn's Disease","enrollment":568},{"nctId":"NCT03706456","phase":"PHASE3","title":"Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease","status":"COMPLETED","sponsor":"Takeda","startDate":"2019-03-06","conditions":"Complex Perianal Fistulas in Adult Participants With Crohn's Disease","enrollment":22},{"nctId":"NCT05322057","phase":"","title":"Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2018-10-01","conditions":"Crohn Disease, Fistula Perianal","enrollment":14},{"nctId":"NCT01541579","phase":"PHASE3","title":"Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease","status":"COMPLETED","sponsor":"Tigenix S.A.U.","startDate":"2012-07","conditions":"Crohn's Disease","enrollment":278},{"nctId":"NCT01372969","phase":"PHASE1, PHASE2","title":"Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.","status":"COMPLETED","sponsor":"Tigenix S.A.U.","startDate":"2009-06","conditions":"Crohn's Disease, Anal Fistula","enrollment":24},{"nctId":"NCT01914887","phase":"PHASE1, PHASE2","title":"Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis","status":"UNKNOWN","sponsor":"Instituto de Investigación Hospital Universitario La Paz","startDate":"2013-06","conditions":"Ulcerative Colitis","enrollment":8},{"nctId":"NCT00999115","phase":"PHASE1, PHASE2","title":"Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)","status":"COMPLETED","sponsor":"Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz","startDate":"2009-09","conditions":"Rectovaginal Fistula, Crohn Disease","enrollment":10}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Cx601","genericName":"Cx601","companyName":"Tigenix S.A.U.","companyId":"tigenix-s-a-u","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}