[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CryoCord Sdn Bhd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100442286","phase-1-safety-of-allogeneic-human-umbilical-cord-mesenchymal-stem-cells-uc-mscs-to-treat-perianal-fistulas-w-crohns-disease-100442286",false,"NCT05039411","Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w\u002F Crohn's Disease","A Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's Disease","Inclusion Criteria:\n\n* Adult men and women age 18 years and above.\n* Diagnosis of perianal fistulae associated with Crohn's disease refractory to medical therapy.\n* Presence of perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment.\n* Fit for surgery.\n\nExclusion Criteria:\n\n* Informed consent refusal.\n* Pregnancy or breastfeeding women.\n* Current diagnosis of active cancer or remission for less than 5 years.\n* Evidence of active sepsis or significant localised infection.\n* Patients with HIV, HBV, HCV or treponema infection, whether active or latent.\n* Patients with documented allergies.\n* Patients who have received infliximab or any other biologics in the 4 weeks before the cell treatment administration.\n* Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.\n* Patients with any other co-morbidity\u002F co-pathologies which is deemed as contraindication to stem cells infusion (infection, administration of steroids).","ALL","18 Years",{"count":19,"type":20},5,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Objectives:\n\nPrimary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease\n\nSecondary: To determine the efficacy of a single\u002Fmultiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).",[26,27],"Perianal Fistula Due to Crohn's Disease","Fistula in Ano",[29,30,31,32],"Perianal fistula","Crohn's Disease","Umbilical cord mesenchymal stem cells (UC-MSCs)","Allogeneic stem cells","RECRUITING","2025-05-07",{"date":36,"type":37},"2025-05-11","ACTUAL",{"date":39,"type":37},"2022-03-01",{"date":41,"type":20},"2026-12-31",{"name":43,"class":44},"CryoCord Sdn Bhd","INDUSTRY",""]