Treatment of Children With Autistic Spectrum Disorder With Autologous Umbilical Cord Blood, a Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Autistic Spectrum Disorder
- Sponsor
- Sheba Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvement of social communication skills
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief 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
Investigators
Dr. Omer Bar-Yosef
M.D.-Ph.D. Peadiatric Neurology and Child Development. The Edmond and Lily Safra Children's Hospital
Sheba Medical Center
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 1.5 years to ≤ 12 years (11 years, 364 days) at the time of visit 1
- •Confirmed clinical DSM-5 diagnosis of Autism Spectrum Disorder using the DSM-5 criteria
- •Fragile X testing performed and negative
- •Available and qualified umbilical cord blood unit with a minimum banked total nucleated cell dose of ≥ 2 x 10e7 cells/kg
- •Stable on current psychiatric medication regimen (dose and dosing schedule) for at least 2 months prior to infusion of study product
- •Normal absolute lymphocyte count (≥1500/uL)
- •Able to travel to Sheba Medical Center University three times (baseline, 6 and 12 months post-baseline), and parent/guardian is able to participate in interim surveys and interviews monthly
- •Parental consent
- •Exclusion Criteria
- •Review of medical records indicates ASD diagnosis not likely
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Improvement of social communication skills
Time Frame: 6 months
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test-ASD
Secondary Outcomes
- Improvement of social communication skills(6 months)
- Functional assessment(6 months)