The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

  • STATUS
    Recruiting
  • participants needed
    12
  • sponsor
    Nagoya University
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Updated on 16 February 2024
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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.

Details
Condition Hypoxic Brain Damage
Age 1years or below
Treatment CL2020 cells
Clinical Study IdentifierNCT04261335
SponsorNagoya University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
Moderate or severe encephalopathy by a Sarnat criteria
Undergone therapeutic hypothermia started before six hours of birth, and done for 72 hours continuously
Birth weight 1,800 g
Heart rate 100/min, and SpO2 90 %
Able to provide voluntary written consent after receiving adequate information about the study (consent will be obtained from an acceptable representative)

Exclusion Criteria

Suspected or confirmed severe congenital abnormalities or chromosomal anomaly
Planned to undergo surgery or radiation therapy
Scheduled to take systemic corticosteroids treatment for over five days
Blood glucose 200 mg/dL
Participation in another clinical study (not exclude patients in observational studies)
Suspected or confirmed active and severe infection
Positive for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody or syphilis serum reaction
History of severe hypersensitivity or anaphylactic reaction
Severe complications
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