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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Single infusion of autologous umbilical cord blood cells
Placebo
Chaim Seba Medical Center
Ramat Gan, Israel
RECRUITINGImprovement of social communication skills
Vineland Adaptive Behavior Scales-Second Edition (VINELAND-II)
Time frame: 6 months
Improvement of social communication skills
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test-ASD
Time frame: 6 months
Improvement of social communication skills
Theory of Mind Inventory - 2
Time frame: 6 months
Functional assessment
Adaptive Behavior Assessment System - Second edition (ABAS-2)
Time frame: 6 months
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