Clinical trial of human neural stem cell transplantation in patients with severe perinatal hypoxic-ischemic brain injury

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001429

Enrollment

Registered

2015-03-30

Start date

2006-08-24

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell : 1) Human neural stem cells grown in medium containing growth factors will be triturated into single cells by trypsin treatment and then washed with normal saline soluti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)-a. A term infants born in gestational age 36 weeks or more, 1)-b. Also at the various tests (complications at birth, Apgar score, whether CPR done, arterial blood gas analysis, physical examination, neurological examination, EEG and brain imaging), patients with the phase of severe hypoxic-ischemic brain injury (neonatal hypoxic-ischemic encephalopathy; diffuse encephalomalacia, peri-rolandic cortex, basal ganglia and thalamus, and brain stem damage, focal or multifocal cerebral infarction), 1)-c. At the Sarnat & Sarnat stage evaluation, patients also with moderate or severe hypoxic-ischemic encephalopathy symptoms, 1)-d. Patients also with at least moderate abnormal findings on EEG 2)-a. Patients born in premature infants, 2)-b. Patients also occurred cystic periventiricular leukomalacia (cystic PVL) by the hypoxia and ischemia, 2)-c. Patients also with multiple cysts (peri-frontal, peri-parietal, peri-occipital white matter, etc.)

Exclusion criteria

Exclusion criteria: 1) Patients with prophylactic anticonvulsants, hypothermia induction therapy, other experimental neuroprotective agent, or a nutritional factor treatment on hypoxic-ischemic brain injury 2) Patients with other cell or stem cell therapy for hypoxic-ischemic brain injury 3) Patients with severe congenital abnormalities 4) Patients with associated infections such as congenital virus 5) Patients with severe chromosomal abnormalities 6) Patients with genetic and metabolic diseases 7) Patients with severe intracranial hemorrhage by delivery damage 8) Patients with birth weight less than 1,800gm in term infants or a growth retardation at intrauterine 9) Patients with microcephaly (the weight and height are above 2SD but head circumference is below 2SD than the normal range) 10) Patients who are unfit for cell transplantation judged by the physician in charge

Design outcomes

Primary

Measure	Time frame
Gross Motor Function Measure (GMFM) score, Bayley score	—

Secondary

Measure	Time frame
Brain MRI	—

Countries

Korea, Republic of

Contacts

Public ContactKook In Park

Yonsei University Health System, Severance Hospital

kipark@yuhs.ac+82-2-2228-2059

Outcome results