Skip to main content
OpenTrials
Completed

NCT Number: NCT04261335

The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoxia-Ischemia, Brain Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

4 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nagoya University Hospital

Nagoya, Aich, 466-8560, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CL2020 cells

Biological

1.5 million or 15 million cells, IV on day 5 to 14 of birth

Primary outcomes

  1. Incidence of adverse events

    Time frame: until 12 weeks after the administration

    Any adverse events are summarized.

Secondary outcomes

  1. Incidence of composite endpoints (death, continuous respiratory support, and continuous use of vasopressors or pulmonary vasodilators)

    Time frame: at 12, 26, 38, 52, and 78 weeks after administration

    Incidence of composite endpoints is summarized.

  2. Mortality

    Time frame: all of the clinical trial period (up to 44 months)

    Mortality is summarized.

  3. Overall survival

    Time frame: all of the clinical trial period (up to 44 months)

    Overall survival is summarized.

  4. Duration of continuous respiratory support

    Time frame: up to 78 weeks

    Duration of continuous respiratory support is summarized.

  5. Duration of continuous use of vasopressors or pulmonary vasodilators

    Time frame: up to 78 weeks

    Duration of continuous use of vasopressors or pulmonary vasodilators is summarized.

  6. 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

    Time frame: 78 weeks after administration

    Each composite scores are summarized. The higher scores mean a better outcome.

  7. The developmental quotient in Kyoto Scale of Psychological Development 2001

    Time frame: 78 weeks after administration

    The developmental quotient is summarized. The higher scores mean a better outcome.

  8. Presence of 1) head control, 2) roll over, 3) sitting position, 4) crawl, 5) independent gait, and 6) meaningful words

    Time frame: at 26, 38, 52, and 78weeks after administration

    Presence of each event is summarized.

  9. Presence of spasticity

    Time frame: 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.

  10. Presence of epilepsy

    Time frame: until 78 weeks after administration

    Presence of spasticity is summarized. The definition of epilepsy is the condition based on the International League Against Epilepsy.

  11. MRI score

    Time frame: 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.

  12. Gross Motor Function Classification System (GMFCS) score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nagoya University

Other

Collaborators

  • Life Science Institute, Inc.

Registry information

Official study title

The Evaluation of Safety and Tolerability of CL2020 in Neonatal Hypoxic Ischemic Encephalopathy Patients With Therapeutic Hypothermia in the Dose Escalation Clinical Trial

Acronym: SHIELD

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 7, 2020
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.