A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2019-08-05

Brief Summary

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This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.

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Detailed Description

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The purpose of this phase II study is to assess the safety and efficacy of up to two intravenous infusions of autologous volume and red blood cell reduced nucleated umbilical cord blood cells as compared with placebo in neonates with neonatal encephalopathy undergoing hypothermia treatment. Efficacy will be estimated by one year survival and score on Bayley III scores in all three domains equal to or greater than 85. This will be a randomized, double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for cooling.

Conditions

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Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention cell recipients

Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment

Group Type EXPERIMENTAL

Infusion of autologous cord blood

Intervention Type BIOLOGICAL

Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.

Placebo recipients

Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.

Interventions

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Infusion of autologous cord blood

Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.

Intervention Type BIOLOGICAL

Placebo

Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

2. Mothers must have consented or given verbal assent for cord blood collection at delivery, and cord blood must be available for volume and red blood cell reduction before 45 hours of age
3. The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age
4. All infants must have signs of encephalopathy within 6 hours of age

Exclusion Criteria

1. Major congenital or chromosomal abnormalities
2. Severe growth restriction (birth weight \<1800 g)
3. Opinion by attending neonatologist that the study may interfere with treatment or safety of subject
4. Moribund neonates for whom no further treatment is planned
5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
6. Infants suspected of overwhelming sepsis
7. ECMO initiated or likely in the first 48 hours of life

Minimum Eligible Age

0 Hours

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No