Intrathecal Stem Cells in Brain Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury

Conditions
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Hypoxia-Ischemia, Cerebral, Cerebral Palsy

Intervention / Treatment
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* Procedure: Intrathecal Autologous Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hypoxic/ischemic brain injury, with an between 1 month and 18 years, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours. Exclusion Criteria: Patients with neurodegenerative or autoimmune diseases. Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure. Patients who do not sign the informed consent form. Elimination Criteria Patients with severe meningeal abnormalities at the time of procedure. Patients who did not attend subsequent assessments 30 and 180 days after the procedure. Patients who die from causes related to neurological disease within 180 days after procedure. Patients who are diagnosed with neurodegenerative or autoimmune diseases after the procedure. Patients who do not bear the proper stimulation process with Granulocyte Colony Stimulating Factor (G-CSF), either by misapplication, lack thereof, or severe adverse drug reaction. Patients choosing to leave the study.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Children whom will receive intrathecal autologous stem cells | Procedure: Intrathecal Autologous Stem Cells<br>* 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.<br>* Other names: Autologous Stem Cells Transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of Battelle Developmental Inventory |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of Battelle Developmental Inventory |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxia, Ischemia, Brain, Children, Cerebral Palsy