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Clinical Trials/NCT02378974
NCT02378974
Completed
Phase 1

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

CHABiotech CO., Ltd1 site in 1 country18 target enrollmentFebruary 2015
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ConditionsCerebral Infarction

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cerebral Infarction
Sponsor
CHABiotech CO., Ltd
Enrollment
18
Locations
1
Primary Endpoint
Number of TEAEs
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
April 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of TEAEs

Time Frame: 6 month

Number of treatment related-adverse events during the study period

Secondary Outcomes

  • Improvement in clinical function as assessed by BI(6 month)
  • Improvement in clinical function as assessed by mRS(6 month)
  • Improvement in clinical function as assessed by Brain MRI tratogram(6 month)
  • Improvement in clinical function as assessed by NIHSS(6 month)

Study Sites (1)

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