Back to results

The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy (SHIELD)

Primary Purpose

Hypoxia-Ischemia, Brain

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

CL2020 cells

About this trial

This is an interventional treatment trial for Hypoxia-Ischemia, Brain focused on measuring Hypoxia-Ischemia, Brain, Infant, Newborn, Mesenchymal Stem Cells

Eligibility Criteria

4 Days - 14 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nagoya University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CL2020 cells

Arm Description

Intravenous injection of CL2020 cells

Outcomes

Primary Outcome Measures

Incidence of adverse events

Any adverse events are summarized.

Secondary Outcome Measures

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

Incidence of composite endpoints is summarized.

Mortality

Mortality is summarized.

Overall survival

Overall survival is summarized.

Duration of continuous respiratory support

Duration of continuous respiratory support is summarized.

Duration of continuous use of vasopressors or pulmonary vasodilators

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

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.

The developmental quotient in Kyoto Scale of Psychological Development 2001

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

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.

Presence of spasticity

Presence of spasticity is summarized. Spasticity is the condition as below: increased muscle tone, or increased deep tendon reflex.

Presence of epilepsy

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

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.

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.

Full Information

NCT ID

NCT04261335

First Posted

February 1, 2020

Last Updated

September 30, 2023

Sponsor

Nagoya University

Collaborators

Life Science Institute, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04261335

Brief Title

The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

March 4, 2020 (Actual)

Primary Completion Date

September 29, 2021 (Actual)

Study Completion Date

December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nagoya University

Collaborators

Life Science Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxia-Ischemia, Brain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

3 + 3 dose escalation study design

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CL2020 cells

Arm Type

Experimental

Arm Description

Intravenous injection of CL2020 cells

Intervention Type

Biological

Intervention Name(s)

CL2020 cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse events

Description

Any adverse events are summarized.

Time Frame

until 12 weeks after the administration

Secondary Outcome Measure Information:

Title

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

Description

Incidence of composite endpoints is summarized.

Time Frame

at 12, 26, 38, 52, and 78 weeks after administration

Title

Mortality

Description

Mortality is summarized.

Time Frame

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

Title

Overall survival

Description

Overall survival is summarized.

Time Frame

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

Title

Duration of continuous respiratory support

Description

Duration of continuous respiratory support is summarized.

Time Frame

up to 78 weeks

Title

Duration of continuous use of vasopressors or pulmonary vasodilators

Description

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

Time Frame

up to 78 weeks

Title

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

Description

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

Time Frame

78 weeks after administration

Title

The developmental quotient in Kyoto Scale of Psychological Development 2001

Description

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

Time Frame

78 weeks after administration

Title

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

Description

Presence of each event is summarized.

Time Frame

at 26, 38, 52, and 78weeks after administration

Title

Presence of spasticity

Description

Presence of spasticity is summarized. Spasticity is the condition as below: increased muscle tone, or increased deep tendon reflex.

Time Frame

at 12, 26, 38, 52, and 78 weeks after administration

Title

Presence of epilepsy

Description

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

Time Frame

until 78 weeks after administration

Title

MRI score

Description

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.

Time Frame

at 2, and 78 weeks after administration

Title

Gross Motor Function Classification System (GMFCS) score

Description

GMFCS score is summarized. The gross motor function can be categorized into 5 different level. The higher scores mean a worse outcome.

Time Frame

at 78 weeks after administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Days

Maximum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoshiaki Sato, MD, PhD

Organizational Affiliation

Department of Center for Maternal Neonatal Care, Nagoya University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nagoya University Hospital

City

Nagoya

State/Province

Aich

ZIP/Postal Code

466-8560

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35473726

Citation

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.

Results Reference

derived

Learn more about this trial

The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

We'll reach out to this number within 24 hrs