Evaluation of the Safety and Potential Therapeutic Effects of Cordstem-ST in Patients With Cerebral Infarction

Cohort 1 : Cordstem-ST cells or Placebo on day 0 Cohort 2: Cordstem-ST cells or Placebo on day 0 and day 7

Inclusion criteria

• Male or female subjects between 19 to 80 years of age (inclusive) at the time of screening visit
• Subjects who are able to receive intravenous Cordstem-ST Transplantation within 7 days (168 hours) of stroke onset
• Subjects with diagnosis of Cerebral Infarction confirmed by the following criteria assessed at the screening visit

• NIHSS score between 5 and 20 (inclusive)
• Acute ischemic lesion involving anterior circulation territory identified in the diffusion weighted MRI
• Signed informed consent

Exclusion criteria

• History of intracranial hemorrhage
• Subjects who are suspected to undergo endarterectomy during the study period. Subjects who received the former procedures not due to cerebral infarction more than 3 months ago, are eligible.
• Subjects with hemorrhagic transformation on brain images, except for petechial hemorrhage ('H1' according to the ECASS classification)
• Subjects at the high risk of developing brain herniation
• History of dementia
• History of epilepsy
• Subjects who have been treated or diagnosed with schizophrenia, depression, or bipolar disorder within the past 6 months
• Subjects with recent (≤3 months) myocardial infarction or stroke other than the index stroke.
• Subjects must not have the following conditions in laboratory tests

• ALT or AST: More than 2.5 times the upper limit of normal
• Serum creatinine: More than 1.5 times the upper limit of normal
• Total bilirubin: More than 2.5 times the upper limit of normal
• Platelet count: less than lower limit of narmal
• Subjects who are HBV, HCV, HIV, VDRL positive
• Subjects in poor general condition due to medical conditions or subjects with severe cardiovascular, gastrointestinal, pulmonary, endocrinologic diseases
• Subjects with active lung diseases, based on chest X-ray
• Subjects with abnormal coagulopathic conditions (thrombocytopenia, congenital coagulopathy, etc.). Medical use of oral anticoagulants is permitted.
• Subjects with known allergies to protein products (Bovine serum) used in the cell production process.
• Subjects with history of pulmonary embolism or deep vein thrombosis
• Subjects with history of malignancy
• Pregnant or lactating women
• Women of childbearing age who reject to practice contraception with one of the following methods

• Use a condom
• Use of contraceptive (oral, dermal, or injectable)
• Use an intra-uterine contraceptive device
• Subjects with a history of alcohol abuse (>30g/day) or drug abuse
• Subjects who cannot undergo MRI scanning
• Subjects who cannot conduct the scheduled monitoring visits
• Subjects who is determined to be inappropriate by the investigators