The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy
Neonates diagnosed moderate/severe Hypoxic-Ischemic Encephalopathy after birth will receive routine therapy and be randomized to four arms for allogenic neural progenitor cells transplantation,paracrine factors of human mesenchymal stem cells intrathecal injection,combination of cell and factor or only routine therapy. Patients will be followed for neurodevelopmental outcome at 12 and 18 months in Pediatrics of Navy General Hospital. Magnetic Resonance Imaging, electroencephalogram, Bailey scores, Peabody development measure scale and Gross motor function measure assessment will be obtained in the following research.Results will be analyzed and described in study reports.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Neural progenitor cells are derived from the same aborted human fetal forebrain.
The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times
Neural progenitor cells will be received after paracrine factors therapy
Navy General Hospital
Beijing, Beijing Municipality, China
RECRUITINGNavy General Hospital
Beijing, China
RECRUITINGNeonatal Behavioral Neurological Assessment
Time frame: 14days after birth
number of adverse events
adverse events like fever、infection、seizures、hemorrhage coursed by interventions
Time frame: 7days after cell or factor injection
Neonatal Behavioral Neurological Assessment
Time frame: 28days after birth
Bayley score
Gross motor function measure assessment for children diagnosed cerebral palsy
Time frame: 12 months after birth
Bayley score
Gross motor function measure assessment for children diagnosed cerebral palsy
Time frame: 18 months after birth
Peabody development measure scale
Gross motor function measure assessment for children diagnosed cerebral palsy
Time frame: 12 months after birth
Peabody development measure scale
Gross motor function measure assessment for children diagnosed cerebral palsy
Time frame: 18 months after birth
Number of death
Time frame: 1 years after birth
Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT
Time frame: 5 years after birth
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