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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03696745
• Other study ID #: GuangdongW C H
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2018
• Source: Guangdong Women and Children Hospital
• Contact: ZhuXiao Ren, MD
• Phone: +8613538984634
• Email: renzhx1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Effect of Drugs
• Safety Issues

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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