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| Name | Class |
|---|---|
| Osaka City University | OTHER |
| Yodogawa Christian Hospital | OTHER |
| Kurashiki Central Hospital | OTHER |
| Nagoya University |
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This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.
The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study "Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618)". Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell-treated | Infants with encephalopathy who receive autologous umbilical cord blood cell therapy along with therapeutic hypothermia. |
| |
| Cooled only | Infants with encephalopathy who receive therapeutic hypothermia only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous cord blood cell therapy | Biological | The neonates receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and intravenously infused at 12-24, 36-48, and 60-72 hours after the birth. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum levels of cytokines and trophic factors | From birth up to 10 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| Association with neuroimaging and neurodevelopmental functional outcome | Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be assessed whether they are associated with serum levels of cytokines and trophic factors during the early neonatal period. | 18 months |
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Inclusion Criteria:
Infants are eligible if they meet all the following inclusion criteria except 4.
Exclusion Criteria:
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Infants with encephalopathy who meet the inclusion criteria of therapeutic hypothermia, either those who receive the cell therapy or those who do not.
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| Name | Affiliation | Role |
|---|---|---|
| Haruo Shintaku, MD, PhD | Osaka City University Graduate School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Kurashiki Central Hospital |
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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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| OTHER |
| Osaka City General Hospital | OTHER |
| Saitama Medical University | OTHER |
| National Cerebral and Cardiovascular Center, Japan | OTHER |
| National Center for Child Health and Development, Japan | OTHER |
| Tokyo University | OTHER |
| Tokyo Women's Medical University | OTHER |
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| Kurashiki |
| Okayama-ken |
| 710-8602 |
| Japan |
| Saitama Medical Center | Kawagoe | Saitama | 350-0495 | Japan |
| Yodogawa Christian Hospital | Osaka | 533-0032 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| Osaka City University Hospital | Osaka | 545-8585 | Japan |
| 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 |