Status:
UNKNOWN
Intrathecal Stem Cells for Cerebral Palsy Phase II
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Cerebral Palsy
Eligibility:
All Genders
7-9 years
Phase:
PHASE2
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 quadriparet...
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, i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02231242
Start Date
September 1 2013
End Date
June 1 2016
Last Update
September 4 2014
Active Locations (1)
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1
Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico, 64460