[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442286":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":19,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":19,"enrollmentInfo":65,"targetDuration":19,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"CryoCord Sdn Bhd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells","EXPERIMENTAL","A total of 60 million PF2020-CELL (UC-MSCs) will be injected locally around the fistula tract, with a separation of 1 cm between injections. All patients will receive a total of 60 million cells per visit for 5 visits, with a 6 - 12 weeks interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed.",[13],"Biological: PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","All patients will receive a total of 60 million PF2020-CELL (UC-MSCs) cells per treatment visit.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"April Camilla Roslani, Prof. Dr.","Department of Surgery, Faculty of Medicine, University of Malaya","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+603-7949 2050","april@ummc.edu.my",[31],{"facility":32,"status":33,"city":34,"state":19,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"University of Malaya Medical Centre","RECRUITING","Kuala Lumpur","59100","Malaysia","MY",{"type":39,"coordinates":40},"Point",[41,42],101.68653,3.1412,{"lat":42,"lon":41},[45,46,47],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":24,"phone":19,"phoneExt":19,"email":19},{"name":48,"role":49,"phone":19,"phoneExt":19,"email":19},"Ida Normiha Hilmi, Prof. Dr.","SUB_INVESTIGATOR",{"type":51,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[53],{"name":54,"class":55},"University of Malaya","OTHER","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":66,"type":67},5,"ESTIMATED","INTERVENTIONAL",[70],"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).",[73,74],"Perianal Fistula Due to Crohn's Disease","Fistula in Ano",[76,77,78,79],"Perianal fistula","Crohn's Disease","Umbilical cord mesenchymal stem cells (UC-MSCs)","Allogeneic stem cells","2025-05-07",{"date":82,"type":83},"2025-05-11","ACTUAL",{"date":85,"type":83},"2022-03-01",{"date":87,"type":67},"2026-12-31",{"name":5,"class":6},1]