NCT02378974

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 9, 2024

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

February 16, 2015

Last Update Submit

April 5, 2024

Conditions

Cerebral Infarction

Keywords

Cerebral InfarctionMesenchymal Stem CellsStroke

Outcome Measures

Primary Outcomes (1)

  • Number of TEAEs

    Number of treatment related-adverse events during the study period

    6 month

Secondary Outcomes (4)

  • Improvement in clinical function as assessed by mRS

    6 month

  • Improvement in clinical function as assessed by NIHSS

    6 month

  • Improvement in clinical function as assessed by BI

    6 month

  • Improvement in clinical function as assessed by Brain MRI tratogram

    6 month

Study Arms (2)

Cohort 1

OTHER

Cordstem-ST cells or Placebo on day 0

Biological: Cordstem-STBiological: Placebo

Cohort 2

OTHER

Cordstem-ST cells or Placebo on day 0 and day 7

Biological: Cordstem-STBiological: Placebo

Interventions

Cordstem-STBIOLOGICAL
Cohort 1Cohort 2
PlaceboBIOLOGICAL
Cohort 1Cohort 2

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects between 19 to 80 years of age (inclusive) at the time of screening visit
  • Subjects who are able to receive intravenous Cordstem-ST Transplantation within 7 days (168 hours) of stroke onset
  • 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
  • Signed informed consent

You may not qualify if:

  • History of intracranial hemorrhage
  • 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.
  • Subjects with hemorrhagic transformation on brain images, except for petechial hemorrhage ('H1' according to the ECASS classification)
  • Subjects at the high risk of developing brain herniation
  • History of dementia
  • History of epilepsy
  • Subjects who have been treated or diagnosed with schizophrenia, depression, or bipolar disorder within the past 6 months
  • Subjects with recent (≤3 months) myocardial infarction or stroke other than the index stroke.
  • 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
  • Subjects who are HBV, HCV, HIV, VDRL positive
  • Subjects in poor general condition due to medical conditions or subjects with severe cardiovascular, gastrointestinal, pulmonary, endocrinologic diseases
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 463-712, South Korea

Location

MeSH Terms

Conditions

Cerebral InfarctionStroke

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ok Joon Kim

    CHA University Bundang Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 4, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 9, 2024

Record last verified: 2019-11

Locations

KR(1)