A pilot feasibility and safety study of autologous umbilical cord blood cell therapy in infants with neonatal encephalopathy
Phase 1
- Conditions
- eonatal encephalopathy (Neonatal hypoxic-ischemic encephalopathy)
- Registration Number
- JPRN-UMIN000014903
- Lead Sponsor
- eonatal Encephalopathy Consortium, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
Not provided
Exclusion Criteria
1) Known major congenital anomalies, such as chromosomal anomalies, heart diseases 2) Major intracranial hemorrhage identified by brain ultrasonography or computed tomography 3) Severe growth restriction, with birth-weight less than 1800 g 4) Severe infectious disease, such as sepsis 5) Hyperkalemia 6) Outborn infants (Infants born at hospitals other than the study sites) 7) Volume of collected cord blood <40 ml 8) Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method