Clinical trial NCT02854579: Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy
Official title: Safety and Efficacy Study of Neural Progenitor Cell Transplantation and Paracrine Factors From Human Mesenchymal Stem Cells to Treat Newborn With Hypoxic-ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Keywords: Hypoxic-Ischemic Encephalopathy
progenitor cell
paracrine factor
adipose mesenchymal stem cell
neonate
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Bethune International Peace Hospital
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Hunan Children's Hospital
name: Shangluo Central Hospital
name: 252 Military Hospital
First posted: 2016-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neonatal Behavioral Neurological Assessment
timeFrame: 14days after birth
measure: number of adverse events
timeFrame: 7days after cell or factor injection
measure: Neonatal Behavioral Neurological Assessment
timeFrame: 28days after birth
Secondary outcomes:
measure: Bayley score
timeFrame: 12 months after birth
measure: Bayley score
timeFrame: 18 months after birth
measure: Peabody development measure scale
timeFrame: 12 months after birth
measure: Peabody development measure scale
timeFrame: 18 months after birth
measure: Number of death
timeFrame: 1 years after birth
measure: Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT
timeFrame: 5 years after birth
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
city: Beijing
country: China
facility: Navy General Hospital
Study officials:
affiliation: Navy General Hosiptal
name: Zuo Luan, MD
role: STUDY_CHAIR
References:
citation: Luan Z, Liu W, Qu S, Du K, He S, Wang Z, Yang Y, Wang C, Gong X. Effects of neural progenitor cell transplantation in children with severe cerebral palsy. Cell Transplant. 2012;21 Suppl 1:S91-8. doi: 10.3727/096368912X633806.
citation: Bruschettini M, Romantsik O, Moreira A, Ley D, Thebaud B. Stem cell-based interventions for the prevention of morbidity and mortality following hypoxic-ischaemic encephalopathy in newborn infants. Cochrane Database Syst Rev. 2020 Aug 19;8(8):CD013202. doi: 10.1002/14651858.CD013202.pub2.