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

Not Applicable

Completed

Conditions: Pregnancy, childbirth and the puerperium

Registration Number: KCT0001429

Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 41

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

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