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| Name | Class |
|---|---|
| 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 |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neural progenitor cell | Experimental | Three doses of Neural progenitor cell (4*10^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy |
|
| 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 |
|
| 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 |
|
| Routine therapy | No Intervention | neonates only receive routine therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neural progenitor cell | Biological | Neural progenitor cells are derived from the same aborted human fetal forebrain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley score | Gross motor function measure assessment for children diagnosed cerebral palsy | 12 months after birth |
| Bayley score | Gross motor function measure assessment for children diagnosed cerebral palsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zuo Luan, MD | Contact | 18600317210 | hjzyyerke@163.com | |
| Weipeng Liu, MD | Contact | 13581797015 | hjzyynicu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zuo Luan, MD | Navy General Hosiptal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy General Hospital | Recruiting | Beijing | Beijing Municipality | 100048 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22507684 | Background | 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. | |
| 32813884 | Derived | 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. |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Shangluo Central Hospital | OTHER |
| 252 Military Hospital | UNKNOWN |
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| Paracrine factors | Biological | The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times |
|
|
| progenitor cell and paracrine factors | Biological | Neural progenitor cells will be received after paracrine factors therapy |
|
| 18 months after birth |
| Peabody development measure scale | Gross motor function measure assessment for children diagnosed cerebral palsy | 12 months after birth |
| Peabody development measure scale | Gross motor function measure assessment for children diagnosed cerebral palsy | 18 months after birth |
| 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 |
| Navy General Hospital | Recruiting | Beijing | 100048 | China |
|
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |