Cerebral Infarction
Conditions
Keywords
Cerebral Infarction, Mesenchymal Stem Cells, Stroke
Brief summary
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
Detailed description
Cohort 1 : Cordstem-ST cells or Placebo on day 0 Cohort 2: Cordstem-ST cells or Placebo on day 0 and day 7
Interventions
BIOLOGICALCordstem-ST
BIOLOGICALPlacebo
Sponsors
CHABiotech CO., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects between 19 to 80 years of age (inclusive) at the time of screening visit 2. Subjects who are able to receive intravenous Cordstem-ST Transplantation within 7 days (168 hours) of stroke onset 3. 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 4. Signed informed consent
Exclusion criteria
1. History of intracranial hemorrhage 2. 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. 3. Subjects with hemorrhagic transformation on brain images, except for petechial hemorrhage ('H1' according to the ECASS classification) 4. Subjects at the high risk of developing brain herniation 5. History of dementia 6. History of epilepsy 7. Subjects who have been treated or diagnosed with schizophrenia, depression, or bipolar disorder within the past 6 months 8. Subjects with recent (≤3 months) myocardial infarction or stroke other than the index stroke. 9. 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 10. Subjects who are HBV, HCV, HIV, VDRL positive 11. Subjects in poor general condition due to medical conditions or subjects with severe cardiovascular, gastrointestinal, pulmonary, endocrinologic diseases 12. Subjects with active lung diseases, based on chest X-ray 13. Subjects with abnormal coagulopathic conditions (thrombocytopenia, congenital coagulopathy, etc.). Medical use of oral anticoagulants is permitted. 14. Subjects with known allergies to protein products (Bovine serum) used in the cell production process. 15. Subjects with history of pulmonary embolism or deep vein thrombosis 16. Subjects with history of malignancy 17. Pregnant or lactating women 18. 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 19. Subjects with a history of alcohol abuse (\>30g/day) or drug abuse 20. Subjects who cannot undergo MRI scanning 21. Subjects who cannot conduct the scheduled monitoring visits 22. Subjects who is determined to be inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of TEAEs | 6 month | Number of treatment related-adverse events during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in clinical function as assessed by mRS | 6 month | Modified Rankin Score (mRS) compared to baseline at 6 months |
| Improvement in clinical function as assessed by NIHSS | 6 month | National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months |
| Improvement in clinical function as assessed by BI | 6 month | Barthel Index (BI) compared to baseline at 6 months |
| Improvement in clinical function as assessed by Brain MRI tratogram | 6 month | Brain MRI tratogram compared to baseline at 6 months |
Countries
South Korea
Outcome results
None listed