The Clinical Trial of CL2020 for Neonatal Hypoxic Ischemic Encephalopathy

JRCT ID: jRCT2043190112

Registered date:06/02/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Neonatal Hypoxic Ischemic Encephalopathy
• Date of first enrollment: 04/03/2020
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Single intravenous injection of CL2020 with 1.5x10^6 or 1.5x10^7 cells

Outcome(s)

• Primary Outcome: Incidence of adverse events until 12 weeks

Secondary Outcome

1) Incidence of composite endpoints (death, continuous respiratory support, and continuous use of vasopressors or pulmonary vasodilators)
2) Mortality and overall survival
3) Duration of continuous respiratory support, and duration of continuous use of vasopressors or pulmonary vasodilators
4) Bayley Scales of Infant and Toddler Development Third edition, Kyoto Scale of Psychological Development 2001
5) Head control, roll over, sitting position, crawl, independent gait, meaningful words
6) Spasticity
7) Epilepsy
8) MRI
9) Gross Motor Function Classification System

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: <= 2weeks old
• Gender: Both

Include criteria

1) At least 36 weeks gestation, and either one of the following criteria (i.-iii.)
i. Apgar score of 5 or less at 10 minutes
ii. Continued resuscitation for at least 10 minutes
iii. pH of less than 7.0 or base deficit of 16 or more 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 coutinuously
4) Birth weight of 1,800g or more
5) Heart rate of 100 or more/min, and SpO2 of 90 % or more
6) Able to provide voluntary written consent after receiving adequate information about the study (consent will be obtained from an acceptable representative)

Exclude 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 of 200 or more mg/dL
5) Participation in another clinical study (not exclude patienets 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

Related Information

• Primary Sponsor: Sato Yoshiaki
• Source(s) of Monetary Support: Life Science Institute, Inc.
• Secondary ID(s): NCT04261335