Hypoxia-Ischemia, Brain
Conditions
Keywords
Hypoxia-Ischemia, Brain, Infant, Newborn, Mesenchymal Stem Cells
Brief summary
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.
Interventions
BIOLOGICALCL2020 cells
1.5 million or 15 million cells, IV on day 5 to 14 of birth
Sponsors
Life Science Institute, Inc.
Nagoya University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3 + 3 dose escalation study design
Eligibility
Sex/Gender
ALL
Age
4 Days to 14 Days
Healthy volunteers
No
Inclusion criteria
1. At least 36 weeks gestation, and either one of the following criteria (i.-iii.) i. Apgar score ≤5 at 10 minutes ii. Continued resuscitation for at least 10 minutes iii. pH \<7.0 or base deficit ≥16 mmol/L in any blood sample obtained within 60 min of birth 2. Moderate or severe encephalopathy by a Sarnat criteria 3. Undergone therapeutic hypothermia started before six hours of birth, and done for 72 hours continuously 4. Birth weight ≥1,800 g 5. Heart rate ≥100/min, and SpO2 ≥90 % 6. Able to provide voluntary written consent after receiving adequate information about the study (consent will be obtained from an acceptable representative)
Exclusion criteria
1. Suspected or confirmed severe congenital abnormalities or chromosomal anomaly 2. Planned to undergo surgery or radiation therapy 3. Scheduled to take systemic corticosteroids treatment for over five days 4. Blood glucose ≥ 200 mg/dL 5. Participation in another clinical study (not exclude patients in observational studies) 6. Suspected or confirmed active and severe infection 7. Positive for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody or syphilis serum reaction 8. History of severe hypersensitivity or anaphylactic reaction 9. Severe complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | until 12 weeks after the administration | Any adverse events are summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | all of the clinical trial period (up to 44 months) | Mortality is summarized. |
| Overall survival | all of the clinical trial period (up to 44 months) | Overall survival is summarized. |
| Duration of continuous respiratory support | up to 78 weeks | Duration of continuous respiratory support is summarized. |
| Duration of continuous use of vasopressors or pulmonary vasodilators | up to 78 weeks | Duration of continuous use of vasopressors or pulmonary vasodilators is summarized. |
| 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 | 78 weeks after administration | Each composite scores are summarized. The higher scores mean a better outcome. |
| Incidence of composite endpoints (death, continuous respiratory support, and continuous use of vasopressors or pulmonary vasodilators) | at 12, 26, 38, 52, and 78 weeks after administration | Incidence of composite endpoints is summarized. |
| Presence of 1) head control, 2) roll over, 3) sitting position, 4) crawl, 5) independent gait, and 6) meaningful words | at 26, 38, 52, and 78weeks after administration | Presence of each event is summarized. |
| Presence of spasticity | at 12, 26, 38, 52, and 78 weeks after administration | Presence of spasticity is summarized. Spasticity is the condition as below: increased muscle tone, or increased deep tendon reflex. |
| Presence of epilepsy | until 78 weeks after administration | Presence of spasticity is summarized. The definition of epilepsy is the condition based on the International League Against Epilepsy. |
| MRI score | at 2, and 78 weeks after administration | 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. |
| Gross Motor Function Classification System (GMFCS) score | at 78 weeks after administration | GMFCS score is summarized. The gross motor function can be categorized into 5 different level. The higher scores mean a worse outcome. |
| The developmental quotient in Kyoto Scale of Psychological Development 2001 | 78 weeks after administration | The developmental quotient is summarized. The higher scores mean a better outcome. |
Countries
Japan
Outcome results
None listed