Clinical trial NCT02231242: Intrathecal Stem Cells for Cerebral Palsy Phase II
Official title: Intrathecal Autologous Stem Cells for Children With Cerebral Palsy Phase II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: brain
children
cerebral palsy
bone marrow stem cells
intrathecal autologous total nucleated cells
quadriparesis
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the infusion of intrathecal autologous bone marrow total nucleated cells would improve the neurologic evolution of pediatric patients with quadriparetic cerebral palsy.

Detailed description: There is accumulated evidence that shows that the administration of bone marrow total nucleated cells (TNC) into the brain may produce some benefits by different mechanisms like cytokine production, in several neurological areas such as motor, social, adaptative and cognitive.

It has been found that after introducing TNC in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be delivered more efficiently to the injured area, compared with intravenous route in patients with neurologic injury.

Patients will be stimulated for 3 consecutive days with subcutaneous granulocyte colony stimulating factor (G-CSF) and then their bone marrow will be harvested according to their weight. Bone marrow will be processed in order to obtain the buffy coat and minimize the amount of red blood cells. An inoculum of 10mL of this TNC will be infused intrathecally. Patients will be evaluated with the "Gross Motor Functional Classification System" before the procedure and one, three and six months after that.

Eligibility criteria: Inclusion Criteria:

* Patients with quadriplegic cerebral palsy, with an age from 7 to 9 years of age, 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

Primary outcomes:
measure: Number of participants who show progress in GMFCS scale after autologous bonemarrow TNC intrathecal infusion.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Consuelo Mancias-Guerra, MD
role: PRINCIPAL_INVESTIGATOR
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