A Pilot Feasibility and Safety Study of Autologous Umbilical Cord Blood Cell Therapy in Infants With Neonatal Encephalopathy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Neonatal Encephalopathy
- Sponsor
- Neonatal Encephalopathy Consortium, Japan
- Enrollment
- 6
- Locations
- 6
- Primary Endpoint
- Adverse event rates
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 encephalopathy.
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 encephalopathy (hypoxic-ischemic encephalopathy). If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate can receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and infused at 12-24, 36-48, and 60-72 hours after the birth. Infants will be followed for safety and neurodevelopmental outcome up to 18 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants are eligible if they meet all the following inclusion criteria except
- •≥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 Criteria
- •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
Outcomes
Primary Outcomes
Adverse event rates
Time Frame: first 30 postnatal days
Adverse event rates (combined rate of death, continuous respiratory support, and continuous use of vasopressor) will be compared between the cell recipients and historical controls at 30 days of age.
Secondary Outcomes
- Efficacy(18 months)