NCT04243382

Treatment of Children With Autistic Spectrum Disorder With Autologous Umbilical Cord Blood, a Pilot Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II, prospective, double blind, placebo-controlled study of the efficacy of autologous umbilical cord blood infusion. The study population will consist of 60 children ages 18 months to 12 years with ASD. The population will be randomly assigned to 2 groups, the study group be treated by cord blood in the beginning of the study and the control group by placebo product. The study will consist of 4 stages Stage 1: initial assessment by physiotherapist and occupational therapist / treatment by cord blood or placebo / blood work before and after treatment Stage 2: at stage 1 + 6 months assessment by physiotherapist and occupational therapist / cross-over treatment by cord blood or placebo / blood work before and after treatment Stage 4: at stage 1 + 12 months assessment by physiotherapist and occupational therapist The primary outcome is improvement of social communication skills six months after treatment at stage 1

Conditions

• Autistic Spectrum Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Autologous umbilical cord blood	Single infusion of autologous umbilical cord blood cells
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2020-02-27
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-01-28
• Last updated: 2021-01-20

Locations

1 site across 1 country: Israel