[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579314":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":20,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":20,"enrollmentInfo":39,"targetDuration":20,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":49,"overallStatus":51,"whyStopped":20,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":20},{"fullName":5,"class":6},"Oxford University Hospitals NHS Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Injection of stem cell into fistulating perianal Crohn's disease","EXPERIMENTAL","At surgery participants will undergo an examination of the anorectum under anaesthesia and if suitable the stem cells will be harvested. Harvest of the bone marrow-derived mesenchymal stem cells is performed by aspirating 60ml of bone marrow. The aspirate is then centrifuged in theatre and the mesenchymal stem cells prepared in theatre by a representative from (Synergy Medical Technologies). Once prepared they are administered immediately into and around the fistula tract. The internal opening is then closed.\n\nIf the participant is not suitable they will undergo best surgical practice and will be excluded from the study. They will then undergo follow-up as dictated by their clinical condition.\n\nAll participants will undergo the procedure as a day case.",[13],"Device: Harvest and injection of stem cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Harvest and injection of stem cells","Stem cells will be harvested from bone marrow aspirate and injected into the fistula tract The stem cells are the device intervention for this trial and we are looking to assess the procedure of harvesting and injecting the stem cells Patients will undergo study questionnaire: Harvey-Bradshaw Index, perianal Crohn's disease activity index, and Short IBD questionnaire will be administered before surgery and then at 6 weeks, 3 and 6 months after stem cell intervention.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Mark Bignell","CONTACT","01865221150","mark.bignell@ouh.nhs.uk",{"type":28,"investigatorFullName":23,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Primary Investigator","100579314","autologous-stem-cells-in-the-management-of-fistulating-perianal-crohns-disease-100579314",false,"NCT06822686","Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease","Assessment of the Feasibility of Autologous Bone Marrow-derived Mesenchymal Stem Cells in the Management of Fistulating Perianal Crohn's Disease","Inclusion Criteria:\n\n* Diagnosed with perianal Crohn's disease\n* Medically controlled proximal disease as confirmed by endoscopy or Harvey Bradshaw Index scores of less than 7 (remission \u002F mild disease)\n* Recent MRI scan to assess fistulating perianal Crohn's\n* Non-branching fistula with no more than 1 internal opening and 2 external opening i.e. a single tract.\n* No previous definitive fistula treatment (seton excluded)\n* In the Investigator's opinion, is able and willing to comply with all trial requirements.\n* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.\n\nExclusion Criteria:\n\n* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.\n* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.\n* Ongoing perianal sepsis or anal stenosis\n* Patients with a defunctioning stoma","ALL","18 Years",{"count":40,"type":41},10,"ESTIMATED","INTERVENTIONAL",[44],"NA","Crohn's disease is a chronic inflammatory condition that can affect any part of the bowel which can be controlled by a combination of medical and surgical treatments but cannot be cured. A 1\u002F3 of patients have involvement of the perianal region. There are several conditions that can affect the perianal region but the most debilitating is the presence of fistulating disease. Fistulae are small tunnels that run under the skin from the inside of the anus to skin outside the anus and are associated with the inflammatory process seen with Crohn's disease. They can cause pain, infection and discharge which adversely affects the quality of life of the patient. Surgery can be used to treat the symptoms however cure is often difficult to achieve.\n\nStem cells have anti-inflammatory potential and have been shown to be a useful treatment for this condition in combination with effective medical therapy. The stem cells used in the studies need to be prepared 48 hours before use which limits their usage and this is not readily available in the UK.\n\nThe proposed study aims to assess the feasibility of using autologous stem cells prepared with a rapid preparation system at the time of surgery, within the operating room (currently in use at Oxford University Hospitals NHS Foundation Trust (OUH) within the orthopaedic department for a different indication) for fistulating anal Crohn's disease. The stem cells are derived from the patients own bone marrow. The patients undergoing surgery would be having it done for the stem cell treatment. They will then undergo 3 follow up visits and complete questionnaires at each visit alongside a clinical assessment. This study is funded by Occtopus (Colorectal charity based in Oxford).",[47,48],"Fistula in Ano","Crohn Disease",[50],"Stem cell","NOT_YET_RECRUITING","2025-02-11",{"date":54,"type":55},"2025-02-12","ACTUAL",{"date":57,"type":41},"2025-03-01",{"date":59,"type":41},"2026-05-01",{"name":5,"class":6}]