Umbilical Cord Blood Therapy in a Child With Eosinophilic Duodenitis and Autism Spectrum Disorder: a Case Study

Study Purpose

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). In 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. To 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. The 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/cognitive/language assessments (e.g., WISC, WPPSI, GMFM, VMI, SELSI, PRES, FIM). Blood samples will be analyzed for eosinophil counts and gene/protein expression related to inflammation, neuroendocrine function, and gut-brain signaling (e.g., TNF-α, IL-6, serotonin, dopamine, GABA, CRH, BDNF). This 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 4 Years
Gender	Male

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Child aged 4 years at the time of enrollment. 2. Diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD) 3. Actively receiving outpatient care at the Department of Rehabilitation Medicine, CHA Bundang Medical Center. 4. Autologous cord blood available and stored at an accredited cord blood bank. 5. Written informed consent provided by a legally authorized representative (parent or guardian) after receiving a full explanation of the study.

Exclusion Criteria:

1. Presence of a severe uncontrolled medical condition that may interfere with cord blood infusion or study assessments. 2. History of severe allergic reaction to components of the investigational product or immunosuppressive agents (e.g., cyclosporine) 3. Current or recent participation (within 30 days) in another interventional clinical trial. 4. Any contraindication to MRI, EEG, or fNIRS assessments (e.g., implanted metal device, severe behavioral intolerance) 5. Determined by the principal investigator to be unsuitable for participation due to safety concerns or noncompliance

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06995274
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bundang CHA Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Autism Spectrum Disorder, Eosinophilic Gastrointestinal Disorders

Arms & Interventions

Arms

Experimental: umbilical cord blood

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 3/6 match for HLA-A, B, DRB1) and total nucleated cell count (≥ 3×10⁷ cells/kg). 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.

Interventions

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. Each 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/10 kg) to reduce the risk of allergic reactions. For allogeneic infusions, oral cyclosporine (0.07 mL/kg twice daily) is administered for 7 days (3 days before, day of, and 3 days after infusion) to minimize immune-mediated reactions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Soyoung Choi

[email protected]

82 031 780 6003

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Clinical Trial Finder