Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy
Safety and Efficacy Study of Neural Progenitor Cell Transplantation and Paracrine Factors From Human Mesenchymal Stem Cells to Treat Newborn With Hypoxic-ischemic Encephalopathy
1 other identifier
interventional
120
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 27, 2014
CompletedFirst Posted
Study publicly available on registry
August 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 3, 2016
July 1, 2016
4.5 years
April 27, 2014
July 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Neonatal Behavioral Neurological Assessment
14days after birth
number of adverse events
adverse events like fever、infection、seizures、hemorrhage coursed by interventions
7days after cell or factor injection
Neonatal Behavioral Neurological Assessment
28days after birth
Secondary Outcomes (6)
Bayley score
12 months after birth
Bayley score
18 months after birth
Peabody development measure scale
12 months after birth
Peabody development measure scale
18 months after birth
Number of death
1 years after birth
- +1 more secondary outcomes
Study Arms (4)
Neural progenitor cell
EXPERIMENTALThree doses of Neural progenitor cell (4\*10\^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy
Paracrine factors
EXPERIMENTALThree doses of concentrated paracrine factors of human mesenchymal stem cell （0.5ml） intrathecally at 12h,24h,48h after birth.+routine therapy
Progenitor cell and paracrine factors
EXPERIMENTALThree 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
Routine therapy
NO INTERVENTIONneonates only receive routine therapy
Interventions
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
Eligibility Criteria
You may qualify if:
- gestational age ≥ 34weeks, body weight ≥ 2kg.
- 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.
- 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.
You may not qualify if:
- Suffer from other serious organic disease or congenital, hereditary metabolic diseases
- Intracranial active infection, or neuromuscular damage outside central nervous system
- potential of hydrogen / electrolyte disorders without improvement or stability
- Coagulation disorders associated with bleeding tendency
- Immune function is not perfect
- Patients or his guardian refuse consent.
- Patients or his guardian don't accept the follow-up schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Navy General Hospital, Beijinglead
- Bethune International Peace Hospitalcollaborator
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical Universitycollaborator
- Hunan Children's Hospitalcollaborator
- Shangluo Central Hospitalcollaborator
- 252 Military Hospitalcollaborator
Study Sites (2)
Navy General Hospital
Beijing, Beijing Municipality, 100048, China
Navy General Hospital
Beijing, 100048, China
Related Publications (2)
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.
PMID: 22507684BACKGROUNDBruschettini 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.
PMID: 32813884DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zuo Luan, MD
Navy General Hosiptal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 27, 2014
First Posted
August 3, 2016
Study Start
January 1, 2013
Primary Completion
July 1, 2017
Study Completion
December 1, 2017
Last Updated
August 3, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share