Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)NCT02455830
Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy
An observational study of Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), run by Neonatal Encephalopathy Consortium, Japan at 6 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)
- What is being tested?
- Autologous cord blood cell therapy
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 6 sitesJapan
- Study dates
- Apr 2015to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Infants are eligible if they meet all the following inclusion criteria except 4.
- ≥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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Saitama Medical Center
Kawagoe, Saitama, 350-0495
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Yodogawa Christian Hospital
Osaka, 533-0032
Osaka City General Hospital
Osaka, 534-0021
Osaka City University Hospital
Osaka, 545-8585
About this study
Official title: A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy
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.
Read the 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.
- Being tested
- Autologous cord blood cell therapy
- Keywords
- Neonatal encephalopathy, Hypoxic-ischemic encephalopathy, Newborn infants, Cytokines, Trophic factors
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cell-treated | Infants with encephalopathy who receive autologous umbilical cord blood cell therapy along with therapeutic hypothermia. Receives: Biological: Autologous cord blood cell therapy | |
| Cooled only | Infants with encephalopathy who receive therapeutic hypothermia only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum levels of cytokines and trophic factors
Measured: From birth up to 10 days of age
Secondary outcomes (1)
Association with neuroimaging and neurodevelopmental functional outcome
Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be assessed whether they are associated with serum levels of cytokines and trophic factors during the early neonatal period.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neonatal Encephalopathy Consortium, Japan
- Sponsor type
- Research network
- Collaborators
- Osaka City University, Yodogawa Christian Hospital, Kurashiki Central Hospital, Nagoya University, Osaka City General Hospital, Saitama Medical University, National Cerebral and Cardiovascular Center, Japan, National Center for Child Health and Development, Japan, Tokyo University, Tokyo Women's Medical University
- Responsible party
- Sponsor
- Investigators
- Haruo Shintaku, MD, PhD, Study director, Osaka City University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455830
- Sponsor's protocol ID
- UMIN000014903-Cytokines
- Status last verified
- Oct 2019
- First submitted
- 26 May 2015
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy
- ClinicalTrials.gov ID
- NCT02455830
- Acronym / sponsor ID
- UMIN000014903-Cytokines
- Keywords
- Neonatal encephalopathy, Hypoxic-ischemic encephalopathy, Newborn infants, Cytokines, Trophic factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Neonatal Encephalopathy Consortium, JapanResearch network
- Collaborators
- Osaka City University, Yodogawa Christian Hospital, Kurashiki Central Hospital, Nagoya University, Osaka City General Hospital, Saitama Medical University, National Cerebral and Cardiovascular Center, Japan, National Center for Child Health and Development, Japan, Tokyo University, Tokyo Women's Medical University
- Study start
- Apr 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell-treated | – | Biological: Autologous cord blood cell therapyInfants with encephalopathy who receive autologous umbilical cord blood cell therapy along with therapeutic hypothermia. |
| Cooled only | – | –Infants with encephalopathy who receive therapeutic hypothermia only. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- Infants are eligible if they meet all the following inclusion criteria except 4.
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous cord blood cell therapyThe 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. | Biological | Cell-treated |
Primary outcome
Changes in serum levels of cytokines and trophic factors
Time frame: From birth up to 10 days of age
1 secondary outcome
Association with neuroimaging and neurodevelopmental functional outcome
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haruo Shintaku, MD, PhD study director
Osaka City University Graduate School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), run by Neonatal Encephalopathy Consortium, Japan at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum levels of cytokines and trophic factors (time frame: From birth up to 10 days of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.