The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

NCT04261335 | Completed Phase 1 DMC

• 2 other identifiers: CAMCR-014jRCT2043190112
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

Hypoxia-Ischemia, Brain; Infant, Newborn; Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Any adverse events are summarized.

  until 12 weeks after the administration

Secondary Outcomes (12)

• 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

• Mortality

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

• Overall survival

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

• Duration of continuous respiratory support

  up to 78 weeks

• Duration of continuous use of vasopressors or pulmonary vasodilators

  up to 78 weeks

Study Arms (1)

CL2020 cells

EXPERIMENTAL

Intravenous injection of CL2020 cells

Biological: CL2020 cells

Interventions

CL2020 cells BIOLOGICAL

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

CL2020 cells

Eligibility Criteria

• Age: 4 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nagoya University: lead
• Life Science Institute, Inc.: collaborator

Study Sites (1)

Nagoya University Hospital

Nagoya, Aich, 466-8560, Japan

Location

Related Publications (2)

• Sato Y, Shimizu S, Ueda K, Suzuki T, Suzuki S, Miura R, Ando M, Tsuda K, Iwata O, Muramatsu Y, Kidokoro H, Hirakawa A, Hayakawa M; SHEILD team. Safety and tolerability of a Muse cell-based product in neonatal hypoxic-ischemic encephalopathy with therapeutic hypothermia (SHIELD trial). Stem Cells Transl Med. 2024 Nov 12;13(11):1053-1066. doi: 10.1093/stcltm/szae071.

  PMID: 39401019 DERIVED

• 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.

  PMID: 35473726 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

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

Study Officials

• Yoshiaki Sato, MD, PhD

  Department of Center for Maternal Neonatal Care, Nagoya University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor at Department of Center for Maternal Neonatal Care, Nagoya University Hospital

Model Details: 3 + 3 dose escalation study design

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 7, 2020
• Study Start: March 4, 2020
• Primary Completion: September 29, 2021
• Study Completion: December 12, 2022
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)