NCT02612155

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

A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Michael Cotten · Academic / Other
• Sex: All
• Age: 0 Hours – 6 Hours
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns

Interventions

Type	Name	Description
BIOLOGICAL	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.
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.

Timeline

• Start date: 2017-03-30
• Primary completion: 2019-08-05
• Completion: 2019-08-05
• First posted: 2015-11-23
• Last updated: 2024-05-16
• Results posted: 2020-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study