Clinical trial NCT02378974: Evaluation of the Safety and Potential Therapeutic Effects of Cordstem-ST in Patients With Cerebral Infarction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cerebral Infarction
Keywords: Cerebral Infarction
Mesenchymal Stem Cells
Stroke
Lead sponsor: CHABiotech CO., Ltd
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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 endarterectomy 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

Primary outcomes:
measure: Number of TEAEs
timeFrame: 6 month
Secondary outcomes:
measure: Improvement in clinical function as assessed by mRS
timeFrame: 6 month
measure: Improvement in clinical function as assessed by NIHSS
timeFrame: 6 month
measure: Improvement in clinical function as assessed by BI
timeFrame: 6 month
measure: Improvement in clinical function as assessed by Brain MRI tratogram
timeFrame: 6 month
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
affiliation: CHA University Bundang Medical Center
name: Ok Joon Kim
role: PRINCIPAL_INVESTIGATOR
References: