None listed
Conditions
Interventions
Drug, Biological/Vaccine, Stem Cell : Dosage:
• A dose level (low dose): 0.5 x 107 cells per 1 kg (0.25 cc/kg)
• B dose level (high dose): 1.0 x 107 cells per 1 kg (0.5 cc/kg)
Administration: Intrave
Sponsors
Medinno
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypoxic ischemic encephalopathy (HIE) 1) Not less than 35 weeks of gestational age and not less than 1,800 grams of birth weight 2) Begin of hypothermia treatment (systemic or selectively cerebral) within 6 hours after birth 3) When investigational product can be administered within 7 days (168 hours) after completion of 72-hour hypothermia treatment 4) Evidence of moderate to severe HIE Intraventricular hemorrhage (IVH) 1) Within 14 days after diagnosis of IVH and within 28 days after birth 2) Premature neonates of 23 or more and less than 34 weeks of gestational age 3) Neonates diagnosed with intraventricular hemorrhage level 3 or 4 according to Papile’s severity classification criteria by brain ultrasound, as below
Exclusion criteria
Exclusion criteria: Hypoxic Ischemic Encephalopathy (HIE) 1) Less than 36 weeks of gestation age or less than 1,800 grams of birth weight 2) Hypothermia treatment began 6 hours after birth 3) History of or suspicious prenatal cerebral hemorrhage or intracranial infection (meningitis and encephalitis caused by bacteria, viruses, tuberculosis, parasites, etc.) 4) Genetic or congenital abnormalities that affect neurodevelopment or require various surgical treatments, i.e., severe congenital brain malformations (hydrocephalus, encephalocele, etc.), cyanotic or non-cyanotic congenital heart defects that cause heart failure, chromosomal abnormalities (Edward syndrome, Patau syndrome, Down syndrome, etc.) and severe congenital malformations (hydrops fetalis, pulmonary hypoplasia, congenital diaphragmatic hernia, congenital pulmonary cyst disease, etc.) 5) Severe congenital infectious diseases (herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.) 6) Microcephaly with head circumference less than 30 cm 7) CRP > 10 mg/dl, active infection that does not respond to appropriate antibiotics, or clinically significant fulminant sepsis 8) Platelet count 10 mg/dl, active infection that does not respond to appropriate antibiotics, or clinically significant fulminant sepsis 4) Platelet count < 50,000/uL that is not expected to be corrected by the time of administration 5) Recurrent metabolic acidosis (pH < 7.1, BE < -20) that is not expected to be corrected by the time of administration of investigational product 6) Expected surgery within 72 hours after administration of investigational product or expected surgery or death within several days after administration of investigational product 7) Patients with a history of participating in other clinical trials 8) Neonates evaluated as unsuitable to participate by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT) ? Death without reason within 6 hours after administration of investigational product ? Anaphylactic shock just after administration of investigational product ;New tumor lesions seen in brain ultrasound at 4 weeks and 12 weeks after the administration of the investigational drug or at 6-month MRI;Serious adverse events associated with the administration of investigational products | — |
Secondary
| Measure | Time frame |
|---|---|
| New tumor lesions seen in 2- and 5-year MRIs;adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactMyung-Eun Lee
Samsung Medical Center
Outcome results
None listed