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

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ClinicalTrials.gov Identifier: NCT02378974
Recruitment Status : Unknown
Verified July 2016 by CHABiotech CO., Ltd.
Recruitment status was:  Active, not recruiting
First Posted : March 4, 2015
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
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 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


Condition or disease Intervention/treatment Phase
Cerebral Infarction Biological: Cordstem-ST Biological: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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-derived Mesenchymal Stem Cells in Patients With Cerebral Infarction
Study Start Date : February 2015
Estimated Primary Completion Date : May 2017

Arm Intervention/treatment
Cohort 1
Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0
Biological: Cordstem-ST
Biological: Placebo
Cohort 2
Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 and day 7
Biological: Cordstem-ST
Biological: Placebo



Primary Outcome Measures :
  1. Number of treatment related-adverse events during the study period [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Improvement in clinical function as assessed by Modified Rankin Score(mRS) compared to baseline at 6 months [ Time Frame: 6 month ]
  2. Improvement in clinical function as assessed by National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months [ Time Frame: 6 month ]
  3. Improvement in clinical function as assessed by Barthel Index (BI) compared to baseline at 6 months [ Time Frame: 6 month ]
  4. Improvement in clinical function as assessed by Brain MRI tratogram compared to baseline at 6 months [ Time Frame: 6 month ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male or female subjects between 19 to 80 years of age (inclusive) at the time of screening visit
  2. Subjects who are able to receive intravenous Cordstem-ST Transplantation within 7 days (168 hours) of stroke onset
  3. 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
  4. Signed informed consent

Exclusion Criteria

  1. History of intracranial hemorrhage
  2. Subjects who are suspected to undergo thrombolytic therapy, endarterectomy or cerebral artery stenting during the study period. Subjects who received the former procedures not due to cerebral infarction more than 3 months ago, are eligible.
  3. Subjects with hemorrhagic transformation on brain images, except for petechial hemorrhage ('H1' according to the ECASS classification)
  4. Subjects at the high risk of developing brain herniation
  5. History of dementia
  6. History of epilepsy
  7. Subjects who have been treated or diagnosed with schizophrenia, depression, or bipolar disorder within the past 6 months
  8. Subjects with recent (≤3 months) myocardial infarction or stroke other than the index stroke.
  9. 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
  10. Subjects who are HBV, HCV, HIV, VDRL positive
  11. Subjects in poor general condition due to medical conditions or subjects with severe cardiovascular, gastrointestinal, pulmonary, endocrinologic diseases
  12. Subjects with active lung diseases, based on chest X-ray
  13. Subjects with abnormal coagulopathic conditions (thrombocytopenia, congenital coagulopathy, etc.). Medical use of oral anticoagulants is permitted.
  14. Subjects with known allergies to protein products (Bovine serum) used in the cell production process.
  15. Subjects with history of pulmonary embolism or deep vein thrombosis
  16. Subjects with history of malignancy
  17. Pregnant or lactating women
  18. Women of childbearing age who reject to practice contraception with one of the following methods

    • Use a condom
    • Use of contraceptive (oral, dermal, or injectable)
    • Use an intra-uterine contraceptive device
  19. Subjects with a history of alcohol abuse (>30g/day) or drug abuse
  20. Subjects who cannot undergo MRI scanning
  21. Subjects who cannot conduct the scheduled monitoring visits
  22. Subjects who is determined to be inappropriate by the investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378974


Locations
Korea, Republic of
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
CHABiotech CO., Ltd

Responsible Party: CHABiotech CO., Ltd
ClinicalTrials.gov Identifier: NCT02378974     History of Changes
Other Study ID Numbers: CHA-CST-101
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: July 2016

Keywords provided by CHABiotech CO., Ltd:
Cerebral Infarction
Mesenchymal Stem Cells
Stroke

Additional relevant MeSH terms:
Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases