[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592580":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":28,"collaborators":20,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":34,"sex":38,"minAge":39,"maxAge":39,"enrollmentInfo":40,"targetDuration":20,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":20,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":20},{"fullName":5,"class":6},"Bundang CHA Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"umbilical cord blood","EXPERIMENTAL","This is a single-arm, open-label, exploratory case study involving one pediatric participant diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). The intervention includes a series of three intravenous umbilical cord blood (UCB) infusions: one autologous UCB infusion followed by two allogeneic UCB infusions at 6-week intervals. Each infusion is performed under sterile conditions at a hospital-based cell therapy center. The donor UCB units are selected based on HLA compatibility (minimum 3\u002F6 match for HLA-A, B, DRB1) and total nucleated cell count (≥ 3×10⁷ cells\u002Fkg). The allogeneic infusions are accompanied by a 7-day low-dose oral cyclosporine regimen to reduce the risk of immune rejection. The total study period includes baseline evaluation, three infusion sessions, and multiple post-infusion follow-up assessments over three months.",[13],"Biological: Umbilical Cord Blood Infusion (Autologous and Allogeneic)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Umbilical Cord Blood Infusion (Autologous and Allogeneic)","The intervention consists of three intravenous infusions of umbilical cord blood (UCB) in a pediatric patient diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). The first infusion uses autologous UCB stored at a certified cord blood bank. The second and third infusions use allogeneic UCB units selected from a hospital-based donor cord blood bank. Donor units are matched at a minimum of 3 out of 6 HLA loci (HLA-A, B, DRB1) and contain ≥ 3×10⁷ total nucleated cells per kilogram of body weight.\n\nEach infusion is administered intravenously via peripheral vein at the Cell Therapy Center of CHA Bundang Medical Center. Prior to each infusion, the participant receives premedication with intravenous chlorpheniramine maleate (0.6 mL\u002F10 kg) to reduce the risk of allergic reactions. For allogeneic infusions, oral cyclosporine (0.07 mL\u002Fkg twice daily) is administered for 7 days (3 days before, day of, and 3 days after infusion) to minimize immune-mediated reactions",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Soyoung Choi","CONTACT","82 031 780 6003","6003","csy505@chamc.co.kr",{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","MinYoung Kim, MD, PhD","Principle Investigator","100592580","umbilical-cord-blood-therapy-in-a-child-with-eosinophilic-duodenitis-and-autism-spectrum-disorder-a-case-study-100592580",false,"NCT06995274","Umbilical Cord Blood Therapy in a Child With Eosinophilic Duodenitis and Autism Spectrum Disorder: a Case Study","Inclusion Criteria:\n\n1. Child aged 4 years at the time of enrollment\n2. Diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD)\n3. Actively receiving outpatient care at the Department of Rehabilitation Medicine, CHA Bundang Medical Center\n4. Autologous cord blood available and stored at an accredited cord blood bank\n5. Written informed consent provided by a legally authorized representative (parent or guardian) after receiving a full explanation of the study\n\nExclusion Criteria:\n\n1. Presence of a severe uncontrolled medical condition that may interfere with cord blood infusion or study assessments\n2. History of severe allergic reaction to components of the investigational product or immunosuppressive agents (e.g., cyclosporine)\n3. Current or recent participation (within 30 days) in another interventional clinical trial\n4. Any contraindication to MRI, EEG, or fNIRS assessments (e.g., implanted metal device, severe behavioral intolerance)\n5. Determined by the principal investigator to be unsuitable for participation due to safety concerns or noncompliance","MALE","4 Years",{"count":41,"type":42},1,"ESTIMATED","INTERVENTIONAL",[45],"NA","This single-case exploratory clinical study aims to evaluate the therapeutic potential of umbilical cord blood (UCB) infusion in a pediatric patient diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). ED is a rare inflammatory gastrointestinal condition characterized by excessive eosinophil infiltration in the duodenal mucosa, often associated with immune hypersensitivity and allergic responses. ASD is a neurodevelopmental disorder marked by deficits in social interaction, communication, and behavioral flexibility. Recent evidence suggests a link between gastrointestinal inflammation and neurodevelopmental symptoms via the gut-brain axis, especially in patients with co-occurring ASD and eosinophilic gastrointestinal disorders (EGIDs).\n\nIn this study, the patient will receive three UCB infusions: one autologous and two allogeneic. The first (autologous) UCB is stored at a certified cord blood bank and will be administered intravenously. Subsequently, two allogeneic UCB infusions will be administered six weeks apart using HLA-matched donor units selected from a hospital-based cord blood repository. The cell product will contain a minimum of 3 × 10⁷ total nucleated cells per kg, and donor-recipient compatibility for HLA A, B, and DRB1 will be considered.\n\nTo support immune tolerance and reduce potential adverse responses, a 7-day course of low-dose oral cyclosporine will be administered with each allogeneic infusion. All cord blood handling, thawing, and infusion will be performed in a cell therapy center under standardized protocols.\n\nThe primary aim is to explore the immune regulatory effects and symptom relief following UCB therapy in this rare comorbid case. Assessments will include brain MRI with DTI, EEG, fNIRS, sensory profiles (SP), social communication questionnaires (SCQ), autism rating scales (K-CARS-2), behavioral checklists (CBCL), gastrointestinal endoscopy, and developmental\u002Fcognitive\u002Flanguage assessments (e.g., WISC, WPPSI, GMFM, VMI, SELSI, PRES, FIM). Blood samples will be analyzed for eosinophil counts and gene\u002Fprotein expression related to inflammation, neuroendocrine function, and gut-brain signaling (e.g., TNF-α, IL-6, serotonin, dopamine, GABA, CRH, BDNF).\n\nThis case study will also track safety indicators including vital signs, laboratory panels, and adverse events. The data may inform the feasibility of future therapeutic use of UCB in children with complex immune-neurodevelopmental conditions.",[48,49],"Autism Spectrum Disorder","Eosinophilic Gastrointestinal Disorders","NOT_YET_RECRUITING","2025-05-27",{"date":53,"type":54},"2025-05-29","ACTUAL",{"date":56,"type":42},"2025-06-01",{"date":58,"type":42},"2025-12-31",{"name":5,"class":6}]