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

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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Infarction
• Intervention / Treatment: Biological: Placebo; Biological: Cordstem-ST

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
      • Cha Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; Cordstem-ST cells or Placebo on day 0	Biological: Placebo; Biological: Cordstem-ST
Other: Cohort 2; Cordstem-ST cells or Placebo on day 0 and day 7	Biological: Placebo; Biological: Cordstem-ST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of TEAEs	Number of treatment related-adverse events during the study period	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in clinical function as assessed by mRS	Modified Rankin Score (mRS) compared to baseline at 6 months	6 month
Improvement in clinical function as assessed by NIHSS	National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months	6 month
Improvement in clinical function as assessed by BI	Barthel Index (BI) compared to baseline at 6 months	6 month
Improvement in clinical function as assessed by Brain MRI tratogram	Brain MRI tratogram compared to baseline at 6 months	6 month

Collaborators and Investigators

• Sponsor: CHABiotech CO., Ltd
• Investigators: Principal Investigator: Ok Joon Kim, CHA University Bundang Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimated): March 4, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Mesenchymal Stem Cells; Cerebral Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Cerebral Infarction
• Other Study ID Numbers: CHA-CST-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No