Evaluation of the Safety and Potential Therapeutic Effects of Cordstem-ST in Patients With Cerebral Infarction
Phase 1
Completed
- Conditions
- Cerebral Infarction
- Interventions
- Biological: Cordstem-STBiological: Placebo
- Registration Number
- NCT02378974
- Lead Sponsor
- CHABiotech CO., Ltd
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Cordstem-ST Cordstem-ST cells or Placebo on day 0 and day 7 Cohort 2 Placebo Cordstem-ST cells or Placebo on day 0 and day 7 Cohort 1 Placebo Cordstem-ST cells or Placebo on day 0 Cohort 1 Cordstem-ST Cordstem-ST cells or Placebo on day 0
- Primary Outcome Measures
Name Time Method Number of TEAEs 6 month Number of treatment related-adverse events during the study period
- Secondary Outcome Measures
Name Time Method 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 mRS 6 month Modified Rankin Score (mRS) 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
Improvement in clinical function as assessed by NIHSS 6 month National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months
Trial Locations
- Locations (1)
CHA Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of