NCT03696745

The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Guangdong Women and Children Hospital · Academic / Other
• Sex: All
• Age: 28 Weeks – 37 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Safety Issues
• Effect of Drugs

Interventions

Type	Name	Description
OTHER	autologous umbilical cord blood stem cells	autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation
DRUG	0.9% Sodium-chloride	0.9% Sodium-chloride in control group

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-09-01
• Completion: 2021-09-01
• First posted: 2018-10-05
• Last updated: 2018-10-05