The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
1.5 million or 15 million cells, IV on day 5 to 14 of birth
Nagoya University Hospital
Nagoya, Aich, Japan
Incidence of adverse events
Any adverse events are summarized.
Time frame: until 12 weeks after the administration
Incidence of composite endpoints (death, continuous respiratory support, and continuous use of vasopressors or pulmonary vasodilators)
Incidence of composite endpoints is summarized.
Time frame: at 12, 26, 38, 52, and 78 weeks after administration
Mortality
Mortality is summarized.
Time frame: all of the clinical trial period (up to 44 months)
Overall survival
Overall survival is summarized.
Time frame: all of the clinical trial period (up to 44 months)
Duration of continuous respiratory support
Duration of continuous respiratory support is summarized.
Time frame: up to 78 weeks
Duration of continuous use of vasopressors or pulmonary vasodilators
Duration of continuous use of vasopressors or pulmonary vasodilators is summarized.
Time frame: up to 78 weeks
The composite score of cognitive scale, language scale, motor scale, social-emotional scale, and adaptive behavior scale in Bayley Scales of Infant and Toddler Development Third edition
Each composite scores are summarized. The higher scores mean a better outcome.
Time frame: 78 weeks after administration
The developmental quotient in Kyoto Scale of Psychological Development 2001
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The developmental quotient is summarized. The higher scores mean a better outcome.
Time frame: 78 weeks after administration
Presence of 1) head control, 2) roll over, 3) sitting position, 4) crawl, 5) independent gait, and 6) meaningful words
Presence of each event is summarized.
Time frame: at 26, 38, 52, and 78weeks after administration
Presence of spasticity
Presence of spasticity is summarized. Spasticity is the condition as below: increased muscle tone, or increased deep tendon reflex.
Time frame: at 12, 26, 38, 52, and 78 weeks after administration
Presence of epilepsy
Presence of spasticity is summarized. The definition of epilepsy is the condition based on the International League Against Epilepsy.
Time frame: until 78 weeks after administration
MRI score
MRI score is summarized. The scoring system is based on the report of Barkovich AJ, et al. (AJNR Am J Neuroradiol. 1998 ;19(1):143-9.) . The higher scores mean a worse outcome.
Time frame: at 2, and 78 weeks after administration
Gross Motor Function Classification System (GMFCS) score
GMFCS score is summarized. The gross motor function can be categorized into 5 different level. The higher scores mean a worse outcome.
Time frame: at 78 weeks after administration