The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

Phase 1

Completed

• Conditions: Hypoxia-Ischemia, Brain
• Interventions: Biological: CL2020 cells

• Registration Number: NCT04261335
• Lead Sponsor: Nagoya University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-01
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2020-03-04
• Primary Completion: 2021-09-29
• Study Completion: 2022-12-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-30
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CL2020 cells	CL2020 cells	Intravenous injection of CL2020 cells

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	until 12 weeks after the administration	Any adverse events are summarized.

Secondary Outcome Measures

Name	Time	Method
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.
Mortality	all of the clinical trial period (up to 44 months)	Mortality 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 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.
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.
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.
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 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.
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 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.
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.

Trial Locations

Locations (1)

Nagoya University Hospital; 🇯🇵 Nagoya, Aich, Japan