Clinical trial NCT03696745: The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
Official title: The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Safety Issues
Effect of Drugs
Keywords: Autologous Umbilical Cord Blood Stem Cells
Safety
Effect
brain injury
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants
timeFrame: during infusion 24 hours after infusion
Secondary outcomes:
measure: effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Gunagzhou,Guangdong,China,511442
name: Jie Yang, PHD
role: PRINCIPAL_INVESTIGATOR
References: