Intrathecal Stem Cells in Brain Injury
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...
Brief Summary
Official Title: “Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: April 2010
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Patients
- Children whom will receive intrathecal autologous stem cells
Outcome Measures for this Clinical Trial
Primary Measures
- Score of "Battelle Developmental Inventory"
- Time Frame: 30 days
Safety Issue?: Yes
- Time Frame: 30 days
Secondary Measures
- Score of "Battelle Developmental Inventory"
- Time Frame: 180 days
Safety Issue?: Yes
- Time Frame: 180 days
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 8 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Hospital Universitario Dr. Jose E. Gonzalez Other
Overall Clinical Trial Officials and Contacts
Maria C Mancias-Guerra, MD Principal Investigator Hospital Universitario Dr. Jose E. Gonzalez
Related Publications
References
Felling RJ, Snyder MJ, Romanko MJ, Rothstein RP, Ziegler AN, Yang Z, Givogri MI, Bongarzone ER, Levison SW. Neural stem/progenitor cells participate in the regenerative response to perinatal hypoxia/ischemia. J Neurosci. 2006 Apr 19;26(16):4359-69.
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Levison SW, Rothstein RP, Romanko MJ, Snyder MJ, Meyers RL, Vannucci SJ. Hypoxia/ischemia depletes the rat perinatal subventricular zone of oligodendrocyte progenitors and neural stem cells. Dev Neurosci. 2001;23(3):234-47.
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Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019733
Study ID Number: HE09-014
ClinicalTrials.gov Identifier: NCT01019733
Health Authority: Mexico: Ethics Committee
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01019733
