The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

NCT ID: NCT04261335

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-04
• Study Completion Date: 2022-12-12

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.

Conditions

Hypoxia-Ischemia, Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CL2020 cells

Intravenous injection of CL2020 cells

Group Type: EXPERIMENTAL

CL2020 cells

Intervention Type: BIOLOGICAL

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

Interventions

CL2020 cells

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Life Science Institute, Inc.

UNKNOWN

Sponsor Role: collaborator

Nagoya University

OTHER

Sponsor Role: lead

Responsible Party

Yoshiaki Sato

MD, PhD, Associate Professor at Department of Center for Maternal Neonatal Care, Nagoya University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoshiaki Sato, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Center for Maternal Neonatal Care, Nagoya University Hospital

Locations

Nagoya University Hospital

Nagoya, Aich, Japan

Countries

Japan

References

Matsuyama N, Shimizu S, Ueda K, Suzuki T, Suzuki S, Miura R, Katayama A, Ando M, Mizuno M, Hirakawa A, Hayakawa M, Sato Y. Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial. BMJ Open. 2022 Apr 26;12(4):e057073. doi: 10.1136/bmjopen-2021-057073.

Reference Type: DERIVED

PMID: 35473726 (View on PubMed)

Other Identifiers

jRCT2043190112

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAMCR-014

Identifier Type: -

Identifier Source: org_study_id