Effect of Drugs, Safety Issues
Conditions
Keywords
Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, brain injury
Brief summary
To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
Detailed description
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.
Interventions
OTHERautologous umbilical cord blood stem cells
autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation
0.9% Sodium-chloride in control group
Sponsors
Guangdong Women and Children Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 37 Weeks
Healthy volunteers
Yes
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
* Presence of known chromosomal anomaly. * Presence of major congenital anomalies. * Severe intrauterine growth restriction (weight \<1800g) * Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist. * Parents refuse consent. * Attending neonatologist refuses consent. * Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants | during infusion 24 hours after infusion | Adverse event rates occurring will be compared between the autologous umbilical cord blood stem cells recipients and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants | 1 year | 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 |
Contacts
Primary ContactZhuXiao Ren, MD
Backup ContactJie Yang, PHD
Outcome results
None listed