Clinical trial NCT01019733: Intrathecal Stem Cells in Brain Injury
Official title: Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia-Ischemia, Cerebral
Cerebral Palsy
Keywords: Hypoxia
Ischemia
Brain
Children
Cerebral Palsy
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Score of "Battelle Developmental Inventory"
timeFrame: 30 days
Secondary outcomes:
measure: Score of "Battelle Developmental Inventory"
timeFrame: 180 days
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose E. Gonzalez
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Maria C Mancias-Guerra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Arturo Garza-Alatorre, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Laura N Rodriguez-Romo, MD
role: STUDY_CHAIR
References:
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citation: Mancias-Guerra C, Marroquin-Escamilla AR, Gonzalez-Llano O, Villarreal-Martinez L, Jaime-Perez JC, Garcia-Rodriguez F, Valdes-Burnes SL, Rodriguez-Romo LN, Barrera-Morales DC, Sanchez-Hernandez JJ, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Gomez-De Leon A, Elizondo-Riojas G, Salazar-Riojas R, Gomez-Almaguer D. Safety and tolerability of intrathecal delivery of autologous bone marrow nucleated cells in children with cerebral palsy: an open-label phase I trial. Cytotherapy. 2014 Jun;16(6):810-20. doi: 10.1016/j.jcyt.2014.01.008. Epub 2014 Mar 15.
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