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Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy

NCT02455830 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2019-10-29

No results posted yet for this study

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.

Conditions

  • Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)

Interventions

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.

Sponsors & Collaborators

  • Osaka City University

    collaborator OTHER

  • Yodogawa Christian Hospital

    collaborator OTHER

  • Kurashiki Central Hospital

    collaborator OTHER

  • Nagoya University

    collaborator OTHER

  • Osaka City General Hospital

    collaborator OTHER

  • Saitama Medical University

    collaborator OTHER

  • National Cerebral and Cardiovascular Center, Japan

    collaborator OTHER

  • National Center for Child Health and Development, Japan

    collaborator UNKNOWN

  • Tokyo University

    collaborator OTHER

  • Tokyo Women's Medical University

    collaborator OTHER

  • Neonatal Encephalopathy Consortium, Japan

    lead NETWORK

Principal Investigators

  • Haruo Shintaku, MD, PhD · Osaka City University Graduate School of Medicine

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2020-03-31
Completion
2020-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02455830 on ClinicalTrials.gov