At a glance
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Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
In Brief
A Phase 3 clinical trial evaluating Autologous Intrathecal Hematopoietic Stem Cells and Observation with IDEA and CARS Scales for Autism and Autism Spectrum. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether the plasticity of autologous intrathecal hematopoietic cells would improve the neurologic and the social skills of pediatric patients with autism spectrum disorders.
Study Details
Timeline
Interventions
Patients will be stimulated with granulocyte colony-stimulating factor (G-CSF) for 3 consecutive days. Bone marrow will be harvested, processed to isolate CD34+ hematopoietic stem cells and reduce red blood cells. An inoculum of 5-10 mL will then be infused intrathecally into the cerebrospinal fluid.
Participants will be observed for 6 months without active intervention. They will be evaluated using the Childhood Autism Rating Scale (CARS) and the IDEA scale at baseline, 30 days, and 180 days. After 6 months, participants may crossover to the experimental arm.