[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539431":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":67,"collaborators":44,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":44,"enrollmentInfo":80,"targetDuration":44,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":51,"whyStopped":44,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous ADRC","EXPERIMENTAL","Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.",[13],"Drug: ADRC injection",{"label":15,"type":10,"description":16,"interventionNames":17},"allogenic ADRC001","Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million cultured allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.",[18],"Drug: ADRC001 injection",[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ADRC injection","Allocated patients will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.",[9],[26,27,28],"Liposuction","Surgical debridement of fistula tract and closure of internal orifice","Injection of lipoaspirate",{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"ADRC001 injection","Allocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.",[15],[26,27,28],[35],{"name":36,"affiliation":37,"role":38},"Karam M Sørensen","OUH","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Karam M Sørensen, Ph.D","CONTACT","+4565415190",null,"ouh.a.forskningsenheden@rsyd.dk",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":45},"Tina D Hansen",[49],{"facility":50,"status":51,"city":52,"state":44,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Odense University Hospital","RECRUITING","Odense","5000","Denmark","DK",{"type":57,"coordinates":58},"Point",[59,60],10.38831,55.39594,{"lat":60,"lon":59},[63,64,65],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":47,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":66,"role":38,"phone":44,"phoneExt":44,"email":44},"Karam M Sørensen, Phd",{"type":38,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Karam Matlub Sørensen, PhD","Primary Investigator (PI)","100539431","phase-1-tissue-therapy-of-transsphincteric-anal-fistula-100539431",false,"NCT06303752","Tissue Therapy of Transsphincteric Anal Fistula","Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics","REP-PAF","Inclusion criterion:\n\nAdult patients (\\>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:\n\n* able to communicate with Danish language\n* able to provide informed consent\n* having address in the region of southern Denmark during the study\n\nExclusion criteria:\n\n1. Signs of suppuration\u002Fcavitation around the fistula\n2. Simple or low anal fistula, which can be treated by simple surgical incision\n3. Ano-vaginal and recto-vaginal fistula\n4. The presence of more than one fistula tract, more than two external orifices or more than one internal orifice\n5. Inflammatory Bowel Disease\n6. Immunosuppression (due to clinical condition or medical therapy)\n7. Malignancy within 5 years\n8. Previous radiotherapy of the abdomen and pelvis\n9. BMI under 18.5\n10. Allergy against the antibiotics: Penicillin and streptomycin.\n11. Coagulopathy\n12. Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)\n13. Verified syphilis, HIV, or hepatitis on screening test","ALL","18 Years",{"count":81,"type":82},75,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.",[89],"Anal Fistula",[91,92,93],"anal fistula","stem cells","ADRC","2024-11-02",{"date":96,"type":97},"2024-11-05","ACTUAL",{"date":99,"type":97},"2024-10-09",{"date":101,"type":82},"2028-10-08",{"name":5,"class":6},1]