A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy
Sponsor study identifier
observational
18
1 country
6
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
May 26, 2015
Actual (reported)May 28, 2015
Actual (reported)March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes in serum levels of cytokines and trophic factors
From birth up to 10 days of age
Association with neuroimaging and neurodevelopmental functional outcome
18 months
Infants with encephalopathy who receive autologous umbilical cord blood cell therapy along with therapeutic hypothermia.
Infants with encephalopathy who receive therapeutic hypothermia only.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Infants with encephalopathy who meet the inclusion criteria of therapeutic hypothermia, either those who receive the cell therapy or those who do not.
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602, Japan
Saitama Medical Center
Kawagoe, Saitama, 350-0495, Japan
Yodogawa Christian Hospital
Osaka, 533-0032, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka City University Hospital
Osaka, 545-8585, Japan
Haruo Shintaku, MD, PhD
Osaka City University Graduate School of Medicine
First Submitted
May 26, 2015
First Posted
May 28, 2015
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2020
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 29, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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