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

Intrathecal Stem Cells in Brain Injury

Sponsors

Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Source 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.

Overall Status Completed
Start Date July 2009
Completion Date January 2011
Primary Completion Date April 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Score of "Battelle Developmental Inventory" 30 days
Secondary Outcome
Measure Time Frame
Score of "Battelle Developmental Inventory" 180 days
Enrollment 18
Condition
Intervention

Intervention type: Procedure

Intervention name: Intrathecal Autologous Stem Cells

Description: 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.

Arm group label: Patients

Other name: Autologous Stem Cells Transplantation

Eligibility

Criteria:

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: All

Minimum age: 1 Year

Maximum age: 8 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Location
facility
Hospital Universitario Dr. Jose E. Gonzalez
Location Countries

Mexico

Verification Date

January 2011

Responsible Party

Name title: Maria del Consuelo Mancías Guerra

Organization: Hospital Universitario Dr. José E. González

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Patients

Arm group type: Experimental

Description: Children whom will receive intrathecal autologous stem cells

Acronym ISC
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov