Randomized, parallel-group comparative study of JR-031 in infants with neonatal hypoxic ischemic encephalopathy (hereinafter referred to as nHIE) for which hypothermia therapy is indicated

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080224818

Enrollment

Registered

2019-08-02

Start date

2019-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infants with neonatal hypoxic ischemic encephalopathy (nHIE)

Interventions

investigational material(s) Generic name etc : JR-031 INN of investigational material : Therapeutic category code : Dosage and Administration for Investigational material : 2.0x10^6 cells/kg/dose.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) An infant diagnosed with nHIE and receiving hypothermia therapy 2) An infant whose parent (legal representative) provides written informed consent

Exclusion criteria

Exclusion criteria: 1) An infant with congenital anomaly (e.g., autosomal chromosome anomaly, congenital heart disease, congenital malformation syndrome) 2) An infant with severe intracranial hemorrhage as detected by cranial ultrasonography or CT 3) An infant with severe infection (e.g., sepsis) 4) An infant with hyperkalemia 5) An infant whose parent has a history of serious drug allergy or hypersensitivity 6) An infant whose mother was treated with another investigational drug or product within 10 months before delivery of the infant 7) An infant whose mother was found to be positive for HBs antigen, HCV antibody, or HIV antibody or be serologically positive for syphilis during pregnancy 8) An infant who, in the opinion of the investigator or subinvestigator, is not appropriate for the study

Design outcomes

Primary

Measure	Time frame
safety efficacy Kyoto Scale of Psychological Development 2001	—

Secondary

Measure	Time frame
safety efficacy 1) Developmental assessment (Kyoto Scale of Psychological Development 2001, Bayley Scales of Infant and Toddler Development Third Edition) 2) Assessment of abnormality on brain MRI scans 3) Gross Motor Function Classification System 4) Assessment of Thompson score 5) Presence or absence of epileptic seizure 6) Presence or absence of gastrostomy 7) Presence or absence of ventilation with tracheostomy 8) Presence or absence of use of inotropes 9) Number of days on artificial ventilation 10) General condition	—

Measure

Time frame

safety efficacy 1) Developmental assessment (Kyoto Scale of Psychological Development 2001, Bayley Scales of Infant and Toddler Development Third Edition) 2) Assessment of abnormality on brain MRI scans 3) Gross Motor Function Classification System 4) Assessment of Thompson score 5) Presence or absence of epileptic seizure 6) Presence or absence of gastrostomy 7) Presence or absence of ventilation with tracheostomy 8) Presence or absence of use of inotropes 9) Number of days on artificial ventilation 10) General condition

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026