Clinical Trial: Evaluation of the Safety and Potential Therapeutic Effects After Intravenous Transplantation of Cordstem-ST in Patients With Cerebral Infarction
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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-de
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 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
Detailed Summary:
Sponsor: CHABiotech CO., Ltd
Current Primary Outcome: Number of treatment related-adverse events during the study period [ Time Frame: 6 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Improvement in clinical function as assessed by Modified Rankin Score(mRS) compared to baseline at 6 months [ Time Frame: 6 month ]
- Improvement in clinical function as assessed by National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months [ Time Frame: 6 month ]
- Improvement in clinical function as assessed by Barthel Index (BI) compared to baseline at 6 months [ Time Frame: 6 month ]
- Improvement in clinical function as assessed by Brain MRI tratogram compared to baseline at 6 months [ Time Frame: 6 month ]
Original Secondary Outcome: Same as current
Information By: CHABiotech CO., Ltd
Dates:
Date Received: February 16, 2015
Date Started: February 2015
Date Completion:
Last Updated: October 30, 2016
Last Verified: July 2016
