NCT02455830

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

4.9 years

First QC Date

May 26, 2015

Last Update Submit

October 28, 2019

Conditions

Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)

Keywords

Neonatal encephalopathyHypoxic-ischemic encephalopathyNewborn infantsCytokinesTrophic factors

Outcome Measures

Primary Outcomes (1)

  • Changes in serum levels of cytokines and trophic factors

    From birth up to 10 days of age

Secondary Outcomes (1)

  • Association with neuroimaging and neurodevelopmental functional outcome

    18 months

Study Arms (2)

Cell-treated

Infants with encephalopathy who receive autologous umbilical cord blood cell therapy along with therapeutic hypothermia.

Biological: Autologous cord blood cell therapy

Cooled only

Infants with encephalopathy who receive therapeutic hypothermia only.

Interventions

Autologous cord blood cell therapyBIOLOGICAL

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.

Cell-treated

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants with encephalopathy who meet the inclusion criteria of therapeutic hypothermia, either those who receive the cell therapy or those who do not.

You may qualify if:

  • ≥36 weeks gestation
  • Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH \<7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
  • Moderate to severe encephalopathy (Sarnat II to III)
  • A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
  • Up to 24 hours of age
  • A person with parental authority must have consented for the study.

You may not qualify if:

  • Known major congenital anomalies, such as chromosomal anomalies, heart diseases
  • Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
  • Severe growth restriction, with birth-weight less than 1800 g
  • Severe infectious disease, such as sepsis
  • Infants judged critically ill and unlikely to benefit from neonatal intensive care including hypothermia by the attending neonatologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Saitama Medical Center

Kawagoe, Saitama, 350-0495, Japan

Location

Yodogawa Christian Hospital

Osaka, 533-0032, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

Osaka City University Hospital

Osaka, 545-8585, Japan

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Haruo Shintaku, MD, PhD

    Osaka City University Graduate School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2020

Study Completion

September 1, 2020

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

JP(6)