NCT02455830

Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy

A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 18 (estimated)
• Sponsor: Neonatal Encephalopathy Consortium, Japan · Network
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

Summary

This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.

Detailed description

The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study "Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618)". Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.

Conditions

• Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)

Interventions

Type	Name	Description
BIOLOGICAL	Autologous cord blood cell therapy	The neonates receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and intravenously infused at 12-24, 36-48, and 60-72 hours after the birth.

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-03-01
• Completion: 2020-09-01
• First posted: 2015-05-28
• Last updated: 2019-10-29

Locations

6 sites across 1 country: Japan