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

Guangdong Women and Children Hospital

Status and phase: Unknown; Phase 1

Conditions: Effect of Drugs; Safety Issues

Treatments: Drug: 0.9% Sodium-chloride; Other: autologous umbilical cord blood stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03696745

GuangdongW C H

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 28 to 37 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% Sodium-chloride

infusion

Experimental group

Description:

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

Treatment:

Other: autologous umbilical cord blood stem cells