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To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
The purpose of this study is to evaluate the safety and effect of infusions of autologous (the patient's own)umbilical cord blood stem cells in newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood stem cells for the Gunagdong Cord Blood Bank,or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood stem cells if an adequate number of cells that meet Guangdong Cord Blood Bank Quality standards are available in the first 14 postnatal days. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride |
|
| infusion | Experimental | preterm infants with severe hypoxic ischemic encephalopathy will receive up to 4 infusions of their own volume reduced cord blood stem cells. The number of doses will be determined by the amount of available cord blood stem cells. The dose for each infusion is 5x107 cells/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous umbilical cord blood stem cells | Other | autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants | Adverse event rates occurring will be compared between the autologous umbilical cord blood stem cells recipients and control group | during infusion 24 hours after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants | the effect of autologous umbilical cord blood stem cells infusion will be measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age | 1 year |
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Inclusion Criteria:
Mothers must have consented for cord blood collection at delivery
cord blood must be available for extraction of stem cells.
->28 weeks gestation,<37weeks gestation
cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
either a 10 minute Apgar < 5 or continued need for ventilation.
All infants must have signs of encephalopathy within 6 hours of age.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZhuXiao Ren, MD | Contact | +8613538984634 | +86 | renzhx1990@163.com |
| Jie Yang, PHD | Contact | 39151777 | 020 | Jjieyang0830@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Yang, PHD | Gunagzhou,Guangdong,China,511442 | Principal Investigator |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.9% Sodium-chloride | Drug | 0.9% Sodium-chloride in control group |
|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D017670 |
| Sodium Compounds |