Cord Blood Infusion for ASD

Autologous cord blood stem cell therapy for children with autism spectrum disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb050240170

Enrollment

Registered

2024-10-28

Start date

2025-07-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder

Interventions

Intravenous infusion of autologous cord blood

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The diagnosis of ASD is based on DSM-5 criteria 2) The child must be between 2 and 4 years old at the time of consent 3) The patient's own cord blood nucleated cells have been cryopreserved at Stem Cell Research Institute Co., Ltd. 4) The patient's HLA typing matches to the ones cryopreserved cord blood 5) Written consent has been obtained from gurdian

Exclusion criteria

Exclusion criteria: 1) Patients with genetic disorder. 2) Patients with malignant disease or brain tumor 3) Patients have immunosuppressant 4) Patients were received another cell therapy for ASD 5) The number of stored nucleated cells in autologous umbilical cord blood is less than 1.0 x 10^7 cells/kg (per subject's body weight) 6) Patients with a history of hypersensitivity to the components of the water-soluble hydrocortisone injection. 7) Patients receiving desmopressin acetate hydrate 8) Patients who are judged inappropriate by investigators

Design outcomes

Primary

Measure	Time frame
Change in Vineland II Adaptive Behavior Scale Communication Skill Domain Standard Scores from Screening Period to 12 Months	—

Secondary

Measure	Time frame
1) Change in Vineland II Adaptive Behavior Scale Communication Skill Domain Standard Scores from Pre-administration to 6 Months 2) Changes in Vineland II Adaptive Behavior Scale, Items Other Than Communication Skill from Pre-administration to 6 Months and 12 Months 3) Rate of Improvement in Visual Selectivity from Pre-administration to 6 Months and 12 Months 4) Changes in ADOS II Comparative Scores from Pre-administration to 12 Months 5) Changes in Developmental Age and Developmental Quotient According to Kyoto Scale of Psychological Development from Pre-administration to 12 Months	—

Measure

Time frame

1) Change in Vineland II Adaptive Behavior Scale Communication Skill Domain Standard Scores from Pre-administration to 6 Months 2) Changes in Vineland II Adaptive Behavior Scale, Items Other Than Communication Skill from Pre-administration to 6 Months and 12 Months 3) Rate of Improvement in Visual Selectivity from Pre-administration to 6 Months and 12 Months 4) Changes in ADOS II Comparative Scores from Pre-administration to 12 Months 5) Changes in Developmental Age and Developmental Quotient According to Kyoto Scale of Psychological Development from Pre-administration to 12 Months

—

Countries

Japan

Contacts

Public ContactTakashi Hamazaki

Osaka Metropolitan University Hospital

hamazaki@omu.ac.jp+81-6-6645-2121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026