Autism Clinical Trial
Official title:
Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
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.
There is accumulating evidence that shows that the administration of hematopoietic cells
into the brain in the patients with spectrum autism could help in the physiopathology of the
illness.
It has been found that after introducing hematopoietic cells in the subarachnoid space of
the spinal cord, these cells may be transported through the cerebrospinal fluid and can be
delivered more efficiently to the injured area, when compared to the intravenous route.
Patients will be stimulated for 3 consecutive days with granulocyte colony stimulating
factor (G-CSF) and then their bone marrow will be harvested according to their weight. Bone
marrow will be processed in order to obtain CD34+ cells and minimize the amount of red blood
cells. An inoculum of 5 to 10mL of stem cells will be infused intrathecally. Patients will
be evaluated with two scales "CARS" and the "IDEA" also we will check the clinical history.
On days 0, 30 and 180.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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