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

Study Overview
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Brief Summary
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The objective of the study is to evaluate the safety and the potential therapeutic effects per dose of Cordstem-ST Intravenous Transplantation in Cerebral Infarction subjects comprised of 2 treatment cohorts: Cohort 1 : Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 Cohort 2: Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 and day 7

Official Title
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A Randomized, Double-blind, Placebo-controlled, Phase I / IIa Clinical Trial for Evaluation of the Safety and Potential Therapeutic Effects After Intravenous Transplantation of Human Umbilical Cord-derived Mesenchymal Stem Cells in Patients With Cerebral Infarction

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Biological: Cordstem-ST
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 | Biological: Cordstem-ST<br> <br> Biological: Placebo<br> <br> |
| Other: Cohort 2<br>Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 and day 7 | Biological: Cordstem-ST<br> <br> Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment related-adverse events during the study period |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in clinical function as assessed by Modified Rankin Score(mRS) compared to baseline at 6 months |  | 6 month | 
| Improvement in clinical function as assessed by National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months |  | 6 month | 
| Improvement in clinical function as assessed by Barthel Index (BI) compared to baseline at 6 months |  | 6 month | 
| Improvement in clinical function as assessed by Brain MRI tratogram compared to baseline at 6 months |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Infarction, Mesenchymal Stem Cells, Stroke