Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy
NCT ID: NCT02854579
Last Updated: 2016-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2013-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neural progenitor cell
Three doses of Neural progenitor cell (4\*10\^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy
neural progenitor cell
Neural progenitor cells are derived from the same aborted human fetal forebrain.
Paracrine factors
Three doses of concentrated paracrine factors of human mesenchymal stem cell （0.5ml） intrathecally at 12h,24h,48h after birth.+routine therapy
Paracrine factors
The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times
Progenitor cell and paracrine factors
Three doses of concentrated paracrine factors 0.5ml intrathecally at 12h,24h,48h after birth.And three doses of neural progenitor cell (4\*10\^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy
progenitor cell and paracrine factors
Neural progenitor cells will be received after paracrine factors therapy
Routine therapy
neonates only receive routine therapy
No interventions assigned to this group
Interventions
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neural progenitor cell
Neural progenitor cells are derived from the same aborted human fetal forebrain.
Paracrine factors
The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times
progenitor cell and paracrine factors
Neural progenitor cells will be received after paracrine factors therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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.
1 Day
14 Days
ALL
No
Sponsors
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Bethune International Peace Hospital
OTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Hunan Children's Hospital
OTHER_GOV
Shangluo Central Hospital
OTHER
252 Military Hospital
UNKNOWN
Navy General Hospital, Beijing
OTHER
Responsible Party
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Zuo Luan
Principal Investigator
Principal Investigators
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Zuo Luan, MD
Role: STUDY_CHAIR
Navy General Hosiptal
Locations
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Navy General Hospital
Beijing, Beijing Municipality, China
Navy General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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NavyGHB-P-01
Identifier Type: -
Identifier Source: org_study_id
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