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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-09-01

Brief Summary

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

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Detailed Description

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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

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Safety Issues Effect of Drugs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo

preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride

Group Type PLACEBO_COMPARATOR

0.9% Sodium-chloride

Intervention Type DRUG

0.9% Sodium-chloride in control group

infusion

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

Group Type EXPERIMENTAL

autologous umbilical cord blood stem cells

Intervention Type OTHER

autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation

Interventions

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autologous umbilical cord blood stem cells

autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation

Intervention Type OTHER

0.9% Sodium-chloride

0.9% Sodium-chloride in control group

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes