Hypoxic-Ischemic EncephalopathyNCT02854579
Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy
A study testing neural progenitor cell, Paracrine factors and progenitor cell and paracrine factors in people with Hypoxic-Ischemic Encephalopathy, run by Navy General Hospital, Beijing at 2 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- neural progenitor cell, Paracrine factors and progenitor cell and paracrine factors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age ≥ 34weeks, body weight ≥ 2kg.
- 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.
- 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.
Who cannot join
- Does not meet the inclusion criteria
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Navy General Hospital
Beijing, Beijing Municipality, 100048
Zuo Luan, MD, hjzyyerke@163.com
Zuo Luan, MD
- Recruiting
Navy General Hospital
Beijing, 100048
Zuo Luan, MD, 18600310270, hjzyyerke@163.com
Weipeng Liu, MD, 135581797015, hjzyynicu@163.com
About this study
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
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
Read the 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.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- neural progenitor cell, Paracrine factors, progenitor cell and paracrine factors
- Keywords
- Hypoxic-Ischemic Encephalopathy, progenitor cell, paracrine factor, adipose mesenchymal stem cell, neonate
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neural progenitor cellBiological
Neural progenitor cells are derived from the same aborted human fetal forebrain.
Paracrine factorsBiological
Also called paracrine factor of human mesenchymal stem cells
The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times
progenitor cell and paracrine factorsBiological
Neural progenitor cells will be received after paracrine factors therapy
| Study group | Role | What they receive |
|---|---|---|
| Neural progenitor cell | Experimental | Three doses of Neural progenitor cell (4*10^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy Receives: Biological: neural progenitor cell |
| Paracrine factors | Experimental | Three doses of concentrated paracrine factors of human mesenchymal stem cell （0.5ml） intrathecally at 12h,24h,48h after birth.+routine therapy Receives: Biological: Paracrine factors |
| Progenitor cell and paracrine factors | Experimental | 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 Receives: Biological: progenitor cell and paracrine factors |
| Routine therapy | No intervention | neonates only receive routine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Behavioral Neurological Assessment
Measured: 14days after birth
number of adverse events
adverse events like fever、infection、seizures、hemorrhage coursed by interventions
Measured: 7days after cell or factor injection
Neonatal Behavioral Neurological Assessment
Measured: 28days after birth
Secondary outcomes (6)
Bayley score
Gross motor function measure assessment for children diagnosed cerebral palsy
Measured: 12 months after birth
Bayley score
Gross motor function measure assessment for children diagnosed cerebral palsy
Measured: 18 months after birth
Peabody development measure scale
Gross motor function measure assessment for children diagnosed cerebral palsy
Measured: 12 months after birth
Peabody development measure scale
Gross motor function measure assessment for children diagnosed cerebral palsy
Measured: 18 months after birth
Number of death
Measured: 1 years after birth
Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT
Measured: 5 years after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Zuo Luan, Navy General Hospital, Beijing
- Investigators
- Zuo Luan, MD, Study chair, Navy General Hosiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854579
- Sponsor's protocol ID
- NavyGHB-P-01
- Status last verified
- Jul 2016
- First submitted
- 27 Apr 2014
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22507684Bruschettini 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.
PubMed 32813884
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02854579
- Acronym / sponsor ID
- NavyGHB-P-01
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Keywords
- Hypoxic-Ischemic Encephalopathy, progenitor cell, paracrine factor, adipose mesenchymal stem cell, neonate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Collaborators
- 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
- Study start
- Jan 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neural progenitor cell | Experimental | Biological: neural progenitor cellThree doses of Neural progenitor cell (4*10^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy |
| Paracrine factors | Experimental | Biological: Paracrine factorsThree 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 | Experimental | Biological: progenitor cell and paracrine factorsThree 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 intervention | –neonates only receive routine therapy |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- gestational age ≥ 34weeks, body weight ≥ 2kg.
- 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.
- 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.
Key exclusion criteria (8 listed)
- Does not meet the inclusion criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neural progenitor cellNeural progenitor cells are derived from the same aborted human fetal forebrain. | Biological | Neural progenitor cell |
| Paracrine factorsAlso: paracrine factor of human mesenchymal stem cellsThe factors obtained from cultured human mesenchymal stem cells were concentrated 50 times | Biological | Paracrine factors |
| progenitor cell and paracrine factorsNeural progenitor cells will be received after paracrine factors therapy | Biological | Progenitor cell and paracrine factors |
Primary outcome
Neonatal Behavioral Neurological Assessment
Time frame: 14days after birth
number of adverse events
Time frame: 7days after cell or factor injection
adverse events like fever、infection、seizures、hemorrhage coursed by interventions
Neonatal Behavioral Neurological Assessment
Time frame: 28days after birth
6 secondary outcomes
Bayley score
Time frame: 12 months after birth
Bayley score
Time frame: 18 months after birth
Peabody development measure scale
Time frame: 12 months after birth
Peabody development measure scale
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Background: PubMed 22507684Luan 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.
- Derived from this study: PubMed 32813884Bruschettini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuo Luan, MD study chair
Navy General Hosiptal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neural progenitor cell, Paracrine factors and progenitor cell and paracrine factors in people with Hypoxic-Ischemic Encephalopathy, run by Navy General Hospital, Beijing at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zuo Luan, MD (18600317210, hjzyyerke@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Behavioral Neurological Assessment (time frame: 14days after birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.