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

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

March 30, 2017

Primary Completion Date

August 5, 2019

Study Completion Date

August 5, 2019

Conditions
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
Interventions
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.

Trial Locations (1)

27710

Duke University Medical Center, Durham

All Listed Sponsors
collaborator

The Robertson Foundation

OTHER

lead

Michael Cotten

OTHER

NCT02612155 - A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy | Biotech Hunter | Biotech Hunter