[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perianal-fistula-due-to-crohns-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perianal-fistula-due-to-crohns-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,69,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100586702","phase-2-db-3q-bmmsc-evs-in-patients-with-perianal-fistulizing-crohns-disease-100586702",false,"NCT06918808","DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease","A Phase 2a Study of Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product (DB-3Q) in Patients With Perianal Fistulizing Crohn's Disease","Inclusion Criteria:\n\n1. Written informed consent from participant\n2. Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1\n3. One or two perianal fistula(s) with 1 or two external openings, that are actively draining\n4. Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)\n5. Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula\n6. Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)\n7. Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) must have been stable for at least 2 weeks prior to Day 1\n8. Oral corticosteroids ≤ 20 mg\u002Fday prednisone or its equivalent and must have been stable for at least 4 weeks prior to Day 1\n9. Approval of a screening pelvic MRI by review of a central radiologist. The definition of an acceptable screening pelvic MRI is provided in the study imaging manual.\n10. Fulfillment of radiologic inclusion by a central radiologist. Radiologic inclusion on MRI is presence of 1 or 2 qualifying perianal fistula(s). Radiologic inclusion assesses anatomic criteria of a perianal fistula and study-defined imaging endpoint criteria. a. Anatomically, a qualifying perianal fistula on MRI fulfills the following from central radiologist assessment: i. has a communication with the internal sphincter of the anal canal ii. is classified as a Parks intersphincteric, transsphincteric, or suprasphincteric perianal fistula. b. For study imaging endpoints, a central radiologist confirms that a fistula has a minimum score of 7 (range 0 to 25) on MAGNIFI-CD and a fistula fibrosis -to-fluid ratio of less than 80%.25, 37 Within components of MAGNIFI-CD, the fistula has a length of 2.5 cm or greater and has a composition of either 'predominantly fluid\u002Fpus' or 'predominantly granulation tissue'. c. Within components of fistula fibrosis-to-fluid ratio, the ratio of hypointense scarring or fibrosis on MRI T2 weighted sequences to hyperintense fluid on MRI T2 weighted sequences is below 80%.25 The fistula is categorized into one of following ranges of fibrosis-to- fluid ratio: i) 0%, ii) 1-19%, iii) 20-39%, iv) 40-59%, or v) 60-79%\n\nExclusion Criteria\n\n1. Lack of informed consent\n2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding\n3. A participant who is unwilling to use medically acceptable contraception methods during participation in study\n4. Active perianal abscess or infection at screening or Day 1\n5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant\n6. Confirmed HIV, Hepatitis B, or Hepatitis C infections\n7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening\n8. History of colorectal cancer within 2 years of screening\n9. History of coagulation disorders and\u002For are currently on anti- coagulant therapy\n10. Presence of a recto\u002Fano-vaginal fistula\n11. Presence of an ileal anal pouch and\u002For history of proctectomy\n12. Presence of severe proctitis (SES CD \\>6)\n13. Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for participant to undergo MRI evaluations (i.e., presence of implantable or external MRI unsafe device that cannot be removed, body weight exceeding limitations, claustrophobia, etc.)\n14. The following out of range laboratory results at screening\n\n    * WBC \\> 13 x 109 \u002FL\n    * Hemoglobin \\\u003C 8 g\u002FdL\n    * Platelet count \\\u003C 100,000\u002FmL\n    * AST\u002FALT \\> 3 times the upper limit of normal\n    * Creatinine \\> 2 μmol\u002FL\n    * PT\u002FINR: 2 times the upper limit of normal\n    * Hemoglobin A1c \\> 6.5 mg\u002FdL\n15. Use of investigational therapy or treatment within 30 days prior to Day 1\n16. Does not meet the radiologic anatomic inclusion criteria: i) has a primary communication with the rectum and not the anal canal; ii) is classified as a Parks extrasphincteric fistula\n17. Does not meet the minimum thresholds for the radiologic imaging endpoint inclusion criteria: i) has a MAGNIFI-CD score of \\\u003C7 (range 0-6) on screening pelvic MRI; ii) has a fibrosis-to-fluid ratio of 80% or more (range 80-100%) on screening pelvic MRI","ALL","18 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.",[27],"Perianal Fistula Due to Crohn's Disease","RECRUITING","2026-05-14",{"date":31,"type":32},"2026-05-15","ACTUAL",{"date":34,"type":32},"2025-05-19",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Direct Biologics, LLC","INDUSTRY",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100442286","phase-1-safety-of-allogeneic-human-umbilical-cord-mesenchymal-stem-cells-uc-mscs-to-treat-perianal-fistulas-w-crohns-disease-100442286","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).",{"count":40,"type":21},[50],"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).",[27,53],"Fistula in Ano",[55,56,57,58],"Perianal fistula","Crohn's Disease","Umbilical cord mesenchymal stem cells (UC-MSCs)","Allogeneic stem cells","2025-05-07",{"date":61,"type":32},"2025-05-11",{"date":63,"type":32},"2022-03-01",{"date":65,"type":21},"2026-12-31",{"name":67,"class":39},"CryoCord Sdn Bhd",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":92,"locationsCount":4},"100555264","expanded-access-protocol-for-stomp-ii-patients-who-were-unable-to-receive-treatment-subsequent-to-adipose-tissue-collection-100555264","NCT06509828","Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection","Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection (EAP-STOMP2)","EAP-STOMP2","Inclusion Criteria:\n\n1. Provision of signed and dated ICF.\n2. Adipose tissue previously collected per the STOMP-II protocol, but were subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew.\n3. Diagnosed with Crohn's disease and a target perianal fistula with one internal opening and at least one external opening.\n\nExclusion Criteria:\n\n1. Suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety.\n2. Pregnant, trying to become pregnant, or are breast feeding. Women of childbearing potential (WCBP) and males who have sexual partners that are WCBP must agree to use an adequate method of contraception while participating in this EAP.\n3. Known allergies or hypersensitivity to aminoglycosides.\n4. History of clinically significant fat-directed autoimmunity.\n5. Active, unresolved infection requiring parenteral antibiotics.\n6. Unresolved abscess at time of treatment (if screening Pelvic MRI identifies an abscess, it must be resolved before treatment).\n7. Target fistula with any of the following characteristics (note that presence of a second fistula tract that is distinctly separate from the target fistula, or a target fistula with a single internal opening and multiple external openings is not exclusionary):\n\n   1. Target fistula has a branching blind ending sinus tract (no external opening) that investigator assesses to be at elevated risk of abscess formation if treated with AVB-114.\n   2. Target fistula is a genito-urinary fistula, including rectovaginal (i.e., fistulae that transverse the vaginal canal).\n   3. Any anatomical limitation to successfully securing the fistula plug disk.","EXPANDED_ACCESS","The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial (STOMP-II), but who were subsequently not treated with AVB-114 because they did not meet all eligibility criteria or the investigational product was not successfully manufactured.",[27],[81,82,83,84,85,86,87],"Matrix plug","Mesenchymal stem cells","Fistula plug","Refractory","Recurrent","STOMP","Autologous","AVAILABLE","2024-07-12",{"date":91,"type":32},"2024-07-19",{"name":93,"class":39},"Avobis Bio, LLC",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":68},"100520030","phase-4-tdm-based-infliximab-treatment-for-active-perianal-fistulizing-crohns-disease-100520030","NCT06051253","TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease","Efficacy of Infliximab Treatment Based on TDM (Therapeutic Drug Monitoring) in Adult Patients With Active Perianal Fistulizing Crohn's Disease","* Inclusion Criteria:\n\n  1. Age: 19-80 years\n  2. Subjects diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, and radiologic findings, etc.\n  3. Subjects naive to both biological drugs (anti-TNFs, anti-integrin, anti-IL12\u002F23, etc.) and investigational new drugs\n  4. Subjects with at least one draining perianal fistula\n  5. Subjects not responding to two or more conventional treatments (antibiotics, drainage, immunosuppressants, etc.)\n  6. Women with a childbearing potential: Those who agree to follow contraception during study drug administration and for at least 6 months from the last dosing of the study medication\n* Exclusion Criteria:\n\n  1. In cases where written informed consents cannot be provided by the study subjects or the subjects' legally acceptable representative\n  2. Subject with a probability of receiving bowel surgery within 12 weeks after baseline, decided by investigators\n  3. Subjects with temporary or permanent stoma\n  4. Subjects with short bowel syndrome\n  5. Subjects not eligible due to significant bowel strictures or intra-abdominal abscesses\n  6. Subjects who received bowel surgery within 6 months of baseline or subjects who were admitted due to complications associated with bowel strictures or intra-abdominal abscesses within 3 months of baseline\n  7. Subjects with enterovaginal fistula, enterocutaneous fistula, or enteroenteric fistula\n  8. Subjects previously exposed to biologics (anti-TNFs, anti-integrin, anti-IL12\u002F23, etc.) or investigational new drugs\n  9. Subjects with a history of hypersensitivity to monoclonal antibody\n  10. Subjects requiring corticosteroid therapy. However, if oral corticosteroid dose lower or equivalent to prednisolone 20 mg\u002Fday before baseline is given and tapering of oral corticoseroid from baseline is planned, that subjects can be included in the study. Oral corticoseroid is tapered at a schedule of prednisolone 5 mg\u002F7 days (example: if the subject was on oral prednisolone 20 mg\u002Fday before baseline, oral prednisolone is tapered as follows: 15 mg\u002Fday x 7 days -\\> 10 mg\u002Fday x 7 days -\\> 5 mg\u002Fday x 7 days -\\> stopping of prednisolone)\n  11. Subjects with active tuberculosis. However, if the subject has a history of tuberculosis, which was cured with standard anti-tuberculosis therapy according to the standard anti-tuberculosis treatment guidelines, that subject can be included\n  12. Subjects with latent tuberculosis: Subjects determined to be positive for latent tuberculosis by the pulmonology specialist after history taking, physical examination, chest X-ray, and interferon gamma release assay during the screening period. However, even if positive for latent tuberculosis, if 4 week-treatment for latent tuberculosis is completed and if further treatment for latent tuberculosis is planned to be completed, that subject can be included\n  13. Subjects positive for HBsAg. In cases of HBsAg (-), but with IgG Anti-HBc (+), real time quantitative PCR for HBV DNA is required. If HBV DNA is 10 IU\u002FmL or over, that subject should be excluded\n  14. Subjects positive for anti-HCV antibody\n  15. Subjects with a history of infection with HIV or subject positive for HIV Ag\n  16. Subjects positive for Clostridioides difficile toxin assay or Clostridioides difficile culture assay\n  17. Subjects with a heart disease of NYHA Class III\u002FIV\n  18. Subjects with current or previous demyelinating disease\n  19. Subject with a history of malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) within 5 years or with a history of dysplasia of colon or small bowel within 5 years.\n  20. Subjects with symptoms or signs of active infection or with a history of treatment for infection within 8 weeks\n  21. Subjects with a history of organ transplantation\n  22. Pregnant or lactating women\n  23. Non-Korean ethnicity according to a family tree\n  24. Subjects decided to be not eligible for the study by investigators","19 Years","80 Years",{"count":104,"type":21},86,[106],"PHASE4","This study will compare the efficacy and safety of TDM (therapeutic drug monitoring)-based infliximab (CT-P13, RemsimaTM) intravenous therapy compared with the standard infliximab (RemsimaTM) intravenous therapy for patients with active perianal fistulzing Crohn's disease.",[109,110,27,111,112],"Crohn Disease","Infliximab","Therapeutic Drug Monitoring","Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease Score","2024-05-11",{"date":115,"type":32},"2024-05-14",{"date":117,"type":32},"2023-11-01",{"date":119,"type":21},"2027-06-30",{"name":121,"class":122},"Asan Medical Center","OTHER"]