Hypoxic-Ischemic Encephalopathy
Conditions
Keywords
Hypoxic-Ischemic Encephalopathy, progenitor cell, paracrine factor, adipose mesenchymal stem cell, neonate
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALneural progenitor cell
Neural progenitor cells are derived from the same aborted human fetal forebrain.
BIOLOGICALParacrine factors
The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times
BIOLOGICALprogenitor cell and paracrine factors
Neural progenitor cells will be received after paracrine factors therapy
Sponsors
Bethune International Peace Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Hunan Children's Hospital
Shangluo Central Hospital
252 Military Hospital
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
No
Inclusion criteria
1. gestational age ≥ 34weeks, body weight ≥ 2kg. 2. 1 minute apgar score ≤3, and 5 minutes apgar score ≤5, OR umbilical arterial blood gas potential of hydrogen\<7.0, OR 30 minutes base excess≤-12 mmol/L, OR need for ventilation 5 minutes after birth. 3. All infants must have signs of encephalopathy (such as convulsion, coma, dystonia, abnormal primitive reflex and irregular respiration) within 6 hours of age or continued abnormal EEG for more than 24h.
Exclusion criteria
1. Does not meet the inclusion criteria 2. Suffer from other serious organic disease or congenital, hereditary metabolic diseases 3. Intracranial active infection, or neuromuscular damage outside central nervous system 4. potential of hydrogen / electrolyte disorders without improvement or stability 5. Coagulation disorders associated with bleeding tendency 6. Immune function is not perfect 7. Patients or his guardian refuse consent. 8. Patients or his guardian don't accept the follow-up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Behavioral Neurological Assessment | 14days after birth | — |
| number of adverse events | 7days after cell or factor injection | adverse events like fever、infection、seizures、hemorrhage coursed by interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bayley score | 12 months after birth | Gross motor function measure assessment for children diagnosed cerebral palsy |
| Peabody development measure scale | 12 months after birth | Gross motor function measure assessment for children diagnosed cerebral palsy |
| Number of death | 1 years after birth | — |
| Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT | 5 years after birth | — |
Countries
China
Contacts
Primary ContactZuo Luan, MD
Backup ContactWeipeng Liu, MD
Outcome results
None listed