Status:
COMPLETED
Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy
Lead Sponsor:
Neonatal Encephalopathy Consortium, Japan
Collaborating Sponsors:
Osaka City University
Yodogawa Christian Hospital
Conditions:
Neonatal Encephalopathy
Hypoxic-ischemic Encephalopathy
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
Brief Summary
This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopath...
Detailed Description
This is a multicenter pilot study to evaluate the feasibility and safety of intravenous infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborns with neonatal ...
Eligibility Criteria
Inclusion
- 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
- Autologous umbilical cord blood available to infuse within 3 days after birth
- A person with parental authority must have consented for the study.
Exclusion
- 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
- Hyperkalemia
- Outborn infants (Infants born at hospitals other than the study sites)
- Volume of collected cord blood \<40 ml
- Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02256618
Start Date
August 1 2014
End Date
July 1 2019
Last Update
October 29 2019
Active Locations (6)
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1
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
2
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan, 710-8602
3
Saitama Medical University
Kawagoe, Saitama, Japan, 350-0495
4
Yodogawa Christian Hospital
Osaka, Japan, 533-0032