NCT06995274

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

Not yet recruiting NA Last updated 29 May 2025

What this trial tests

NA trial testing Umbilical Cord Blood Infusion (Autologous and Allogeneic) in Autism Spectrum Disorder in 1 participant. Not yet recruiting.

Timeline

1 June 2025

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Bundang CHA Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	1 June 2025
Primary completion	31 December 2025
Estimated completion	31 December 2025

Drugs / interventions tested

• Umbilical Cord Blood Infusion (Autologous and Allogeneic) — full drug profile →

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
• Eosinophilic Gastrointestinal Disorders — all drugs for Eosinophilic Gastrointestinal Disorders →

Sponsor

Bundang CHA Hospital

Who can join

Adults 4 to 4, male only, with Autism Spectrum Disorder or Eosinophilic Gastrointestinal Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.