The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

Hypoxia-Ischemia, Brain Clinical Trial

— SHIELD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261335
• Other study ID #: CAMCR-014
• Secondary ID: jRCT2043190112
• Status: Completed
• Phase: Phase 1
• Start date: March 4, 2020
• Est. completion date: December 12, 2022

Study information

• Verified date: September 2023
• Source: Nagoya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 12, 2022
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Days to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia

Intervention

Biological:
• CL2020 cells
1.5 million or 15 million cells, IV on day 5 to 14 of birth

Locations

Country	Name	City	State
Japan	Nagoya University Hospital	Nagoya	Aich

Sponsors (2)

Lead Sponsor	Collaborator
Nagoya University	Life Science Institute, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Any adverse events are summarized.	until 12 weeks after the administration
Secondary	Incidence of composite endpoints (death, continuous respiratory support, and continuous use of vasopressors or pulmonary vasodilators)	Incidence of composite endpoints is summarized.	at 12, 26, 38, 52, and 78 weeks after administration
Secondary	Mortality	Mortality is summarized.	all of the clinical trial period (up to 44 months)
Secondary	Overall survival	Overall survival is summarized.	all of the clinical trial period (up to 44 months)
Secondary	Duration of continuous respiratory support	Duration of continuous respiratory support is summarized.	up to 78 weeks
Secondary	Duration of continuous use of vasopressors or pulmonary vasodilators	Duration of continuous use of vasopressors or pulmonary vasodilators is summarized.	up to 78 weeks
Secondary	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	Each composite scores are summarized. The higher scores mean a better outcome.	78 weeks after administration
Secondary	The developmental quotient in Kyoto Scale of Psychological Development 2001	The developmental quotient is summarized. The higher scores mean a better outcome.	78 weeks after administration
Secondary	Presence of 1) head control, 2) roll over, 3) sitting position, 4) crawl, 5) independent gait, and 6) meaningful words	Presence of each event is summarized.	at 26, 38, 52, and 78weeks after administration
Secondary	Presence of spasticity	Presence of spasticity is summarized. Spasticity is the condition as below: increased muscle tone, or increased deep tendon reflex.	at 12, 26, 38, 52, and 78 weeks after administration
Secondary	Presence of epilepsy	Presence of spasticity is summarized. The definition of epilepsy is the condition based on the International League Against Epilepsy.	until 78 weeks after administration
Secondary	MRI score	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.	at 2, and 78 weeks after administration
Secondary	Gross Motor Function Classification System (GMFCS) score	GMFCS score is summarized. The gross motor function can be categorized into 5 different level. The higher scores mean a worse outcome.	at 78 weeks after administration