Autologous Cord Blood Cells for Brain Injury in Term Newborns

National University Health System (NUHS)

Status and phase: Completed; Phase 1

Conditions: Hypoxic Ischemic Encephalopathy

Treatments: Biological: Autologous cord blood

Study type: Interventional

Funder types: Other

Identifiers

NCT01649648

NMRC/EDG/1032/2, EDG09nov061

Details and patient eligibility

About

This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed).

Full description

The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old.

Enrollment: 2 patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Autologous umbilical cord blood available
2. >36 weeks gestation
3. Brain injury that satisfies criteria for therapeutic hypothermia
4. Parental informed consent

Exclusion criteria

1. Inability to enroll by 3 postnatal days of age.
2. Presence of known chromosomal anomaly.
3. Presence of major congenital anomalies.
4. Severe intrauterine growth restriction
5. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
6. Parents refuse consent.
7. Attending neonatologist refuses consent.
8. Failure to collect the infant's cord blood and/or laboratory unable to process cord blood

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Intervention

Experimental group

Description:

Autologous cord blood cells arm

Treatment:

Biological: Autologous cord blood