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Cerebral InfarctionPhase 1/2NCT02378974

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

A Phase 1/2 study testing Cordstem-ST in people with Cerebral Infarction, run by CHABiotech CO., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Cerebral Infarction
What is being tested?
Cordstem-ST
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteSouth Korea
Study dates
Feb 2015to Apr 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • Subjects with active lung diseases, based on chest X-ray
  • Subjects with abnormal coagulopathic conditions (thrombocytopenia, congenital coagulopathy, etc.). Medical use of oral anticoagulants is permitted.
  • Subjects with known allergies to protein products (Bovine serum) used in the cell production process.
  • Subjects with history of pulmonary embolism or deep vein thrombosis
  • Subjects with history of malignancy
  • Pregnant or lactating women
  • 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
  • Subjects with a history of alcohol abuse (>30g/day) or drug abuse
  • Subjects who cannot undergo MRI scanning
  • Subjects who cannot conduct the scheduled monitoring visits
  • Subjects who is determined to be inappropriate by the investigators

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 463-712

Other trials in South Korea

About this study

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

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

Read the 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

Being tested
Cordstem-ST, Placebo
Keywords
Cerebral Infarction, Mesenchymal Stem Cells, Stroke
Medical subject headings
Cerebral Infarction, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cordstem-STBiological

  • PlaceboBiological

Study groups in NCT02378974
Study groupRoleWhat they receive
Cohort 1OtherCordstem-ST cells or Placebo on day 0
Receives: Biological: Cordstem-ST; Biological: Placebo
Cohort 2OtherCordstem-ST cells or Placebo on day 0 and day 7
Receives: Biological: Cordstem-ST; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of TEAEs

    Number of treatment related-adverse events during the study period

    Measured: 6 month

Secondary outcomes (4)

  1. Improvement in clinical function as assessed by mRS

    Modified Rankin Score (mRS) compared to baseline at 6 months

    Measured: 6 month

  2. Improvement in clinical function as assessed by NIHSS

    National Institute of Health Stroke Scale (NIHSS) compared to baseline at 6 months

    Measured: 6 month

  3. Improvement in clinical function as assessed by BI

    Barthel Index (BI) compared to baseline at 6 months

    Measured: 6 month

  4. Improvement in clinical function as assessed by Brain MRI tratogram

    Brain MRI tratogram compared to baseline at 6 months

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02378974
Sponsor's protocol ID
CHA-CST-101
Status last verified
Nov 2019
First submitted
16 Feb 2015
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cordstem-ST in people with Cerebral Infarction, run by CHABiotech CO., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of TEAEs (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02378974.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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