An interventional study of Intrathecal Autologous Stem Cells in Hypoxia-Ischemia, Cerebral and Cerebral Palsy, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2011-01-26.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether the plasticity of autologous intrathecal hematopoietic cells would improve the neurologic evolution of the pediatric patients with hypoxic/ischemic brain injury.
There is accumulating evidence that shows that the placement of hematopoietic cells in the brain may increase growth-enhancing factors of axons and generate active neurons in the receptor. 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 deliver more efficiently to the injured area, when compared to the intravenous route. Patients will be stimulated 4 times and then harvest the bone marrow. Bone marrow will be processed in order to obtain hematopoietic cells (CD34+) and minimize the erythrocytes amount. A inoculum of 5 to 10mL of stem cells will be infused intrathecally. Patients will be evaluated with the "Battelle Developmental Inventory" before the procedure and one and six months after that. An MRI will be performed before the procedure and six months after that.
240 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 85 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 140 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Elimination Criteria
Children whom will receive intrathecal autologous stem cells
Procedure: Intrathecal Autologous Stem Cells
Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) 5 times, harvest bone marrow and infused 8 to 10 mL of stem cells (CD34+) by intrathecal via.
Also known as: Autologous Stem Cells Transplantation
Score of "Battelle Developmental Inventory"
Time frame: 30 days
Score of "Battelle Developmental Inventory"
Time frame: 180 days
The record gives a start of Jul 2009, a primary completion of Apr 2010 and a completion of Jan 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Dr. Jose E. Gonzalez