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

Recruiting

Phase 1/2 Results N/A

Trial Description

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

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Cohort 1
    Description: Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0
    ARM 2: Kind: Experimental
    Label: Cohort 2
    Description: Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 and day 7
  • Cordstem-ST Biological
    ARM 1: Kind: Experimental
    Label: Cohort 1
    Description: Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0
    ARM 2: Kind: Experimental
    Label: Cohort 2
    Description: Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 and day 7

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of treatment related-adverse events during the study period 6 month Yes
Secondary Improvement in clinical function as assessed by Modified Rankin Score(mRS) compared to baseline at 6 months 6 month No
Secondary Improvement in clinical function as assessed by National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months 6 month No
Secondary Improvement in clinical function as assessed by Barthel Index (BI) compared to baseline at 6 months 6 month No
Secondary Improvement in clinical function as assessed by Brain MRI tratogram compared to baseline at 6 months 6 month No
Secondary Improvement in clinical function as assessed by Modified Rankin Score(mRS) compared to baseline at 6 months 6 month No
Secondary Improvement in clinical function as assessed by National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months 6 month No
Secondary Improvement in clinical function as assessed by Barthel Index (BI) compared to baseline at 6 months 6 month No
Secondary Improvement in clinical function as assessed by Brain MRI tratogram compared to baseline at 6 months 6 month No

Sponsors