Cerebral Palsy Clinical Trial
Official title:
Intrathecal Autologous Stem Cells for Children With Cerebral Palsy Phase II
The purpose of this study is to determine whether the infusion of intrathecal autologous bone marrow total nucleated cells would improve the neurologic evolution of pediatric patients with quadriparetic cerebral palsy.
There is accumulated evidence that shows that the administration of bone marrow total
nucleated cells (TNC) into the brain may produce some benefits by different mechanisms like
cytokine production, in several neurological areas such as motor, social, adaptative and
cognitive.
It has been found that after introducing TNC 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, compared with intravenous route in patients with neurologic
injury.
Patients will be stimulated for 3 consecutive days with subcutaneous 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 the buffy coat and minimize the
amount of red blood cells. An inoculum of 10mL of this TNC will be infused intrathecally.
Patients will be evaluated with the "Gross Motor Functional Classification System" before
the procedure and one, three and six months after that.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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