Clinical trial

Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.

Name

Pro00000412

Description

This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.

Trial arms

Trial start

2008-01-01

Estimated PCD

2017-01-01

Trial end

2017-01-01

Status

Completed

Phase

Early phase I

Treatment

infusion of autologous cord blood

infants who meet study enrollment criteria for history of moderate to severe hypoxic ischemic encephalopathy in the neonatal period will receive up to 4 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells. The dose for each infusion is 5x10e7 cells/kg

Arms:

infusions

Neurodevelopmental outcomes

historical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood

Arms:

historical control

Size

Primary endpoint

Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls.

during infusions: first 18 postnatal days

Eligibility criteria

Inclusion Criteria: * Mothers must have consented for cord blood collection at delivery * cord blood must be available for extraction of stem cells. * \>34 weeks 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: * Inability to enroll by 14 days of age. * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}

Updated at

2024-05-16

1 organization

1 product

1 indication

Organization

Michael Cotten

Product

Infusion of Autologous Cord Blood

Indication

Neonatal Hypoxic Ischemic Encephalopathy