Intrathecal Stem Cells in Brain Injury

Not Applicable

Completed

• Conditions: Hypoxia-Ischemia, Cerebral; Cerebral Palsy
• Interventions: Procedure: Intrathecal Autologous Stem Cells

• Registration Number: NCT01019733
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2010-04
• Status Verified: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Intrathecal Autologous Stem Cells	Children whom will receive intrathecal autologous stem cells

Primary Outcome Measures

Name	Time	Method
Score of "Battelle Developmental Inventory"	30 days

Secondary Outcome Measures

Name	Time	Method
Score of "Battelle Developmental Inventory"	180 days

Trial Locations

Locations (1)

Hospital Universitario Dr. Jose E. Gonzalez; 🇲🇽 Monterrey, Nuevo Leon, Mexico