The STem Cell Application Researches and Trials In NeuroloGy-2 (STARTING-2) Study (STARTING-2)

April 24, 2017 updated by: Oh Young Bang, Samsung Medical Center

Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke: A Single Center, Randomized, Open Label, Prospective, Phase 3 Study

The objectives of this study was to test hypothesis that ischemic stroke patients having moderate to severe persistent neurologic deficit will have better outcomes with intravenous transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum that is obtained at acute phase of stroke than patients receiving standard treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, we will use autologous 'ischemic' serum that obtained at the earliest time point as possible (immediate after randomization) for the purpose of ischemic preconditioning. We have recently conducted preclinical studies on the effects of ischemic preconditioning on the MSC functions. We have evaluated the characteristics of rat MSCs after culture with fetal bovine serum (FBS) or serum obtained from rat stroke model. Compared to FBS, the use of serum obtained from rat stroke model resulted in more rapid expansion of MSCs, which reduces cell preparation time by increase in G2/M phase, decreased cell death/senescence, increased trophic factor secretion, and increased migration capacity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135710
        • Recruiting
        • Samsung Medical Center, Sungkyunkwan University School of Medicine
        • Sub-Investigator:
          • Gyeong Joon Moon, PhD
        • Sub-Investigator:
          • Yun-Hee Kim, MD
        • Sub-Investigator:
          • Sookyoung Ryoo, MD
        • Sub-Investigator:
          • Yeon Hee Cho, MS
        • Sub-Investigator:
          • Yoon Mi Kang, PhD
        • Sub-Investigator:
          • Yong Man Kim, PhD
        • Sub-Investigator:
          • Hyun Soo Kim, MD
        • Sub-Investigator:
          • Jun Ho Jang, MD
        • Sub-Investigator:
          • Won Hyuk Chang, MD
        • Sub-Investigator:
          • Dong Hee Kim, BA
        • Sub-Investigator:
          • Ji-Yoon Nam, BA
        • Sub-Investigator:
          • Ji Hyun Lee, BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women (women must be of non-child bearing potential), age 30-75 yrs.
  2. Have a stroke that is observed within 90 days of the onset of symptoms

  3. Radiologically

    1. Relevant lesions within the middle cerebral artery territory (MCA) as assessed using diffusion-weighted imaging (DWI).
    2. The maximum diameter of the stroke region in any dimension must be ≥15 mm.
    3. Not involving more than a half of the ipsilateral periventricular zone

  4. Clinically (National Institutes of Health stroke scale, NIHSS)

    1. Moderate-to severe persistent neurologic deficit (NIHSS of 6-21 inclusive)
    2. New onset of extremity paresis on the affected side, defined as a score of 2-4 on the NIHSS Motor Arm (item 5) or Leg (item 6) question.
    3. Must be alert or drowsy but easily arousable as defined by score of 0-1 on the NIHSS Level of Consciousness question (item 1).
    4. "Slow recovery" defined as Change in NIHSS ≤1 point/3 days

  5. Willingness

    1. Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits.
    2. Able to participate in the evaluation process to the point of accurate assessment.
    3. Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures.
    4. Evidence of a personally signed and dated informed consent document.

Exclusion Criteria:

  1. Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke modified Rankin score of 2 or more.

  2. Have a stroke that is either

    1. lacunar infarction
    2. Hematologic cause of stroke
    3. Recurrent or progressive stroke within 1 week at the time of screening.
  3. Hematologic disorders or bone marrow suppression.

  4. Have a severe medical illness

    1. Severe heart failure
    2. Severe febrile illness
    3. Hepatic or renal dysfunction
    4. Active cancer
    5. Any evidence of chronic co-morbid condition or unstable acute systemic illnesses which, in the opinion of the investigator, could shorten the subject's survival or limit ability to complete the study.
  5. Presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis on admission blood tests
  6. Presence of depression that is active and not adequately controlled such that it interfere with major activities of daily living immediately prior to the current stroke.
  7. Presence of dementia prior to the current stroke that is likely to confound clinical evaluation.
  8. Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test or lactating females.
  9. Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol
  10. Subjects unwilling to undergo bone marrow aspiration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Mesenchymal stem cell treatment
Other: Mesenchymal stem cell
intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum
NO_INTERVENTION: Standard treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Categorical shift in modified Rankin scale (mRS)
Time Frame: 90 days after the cell treatment
Categorical shift in mRS at 90 days after the cell treatment
90 days after the cell treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of National Institutes of Health stroke scale (NIHSS)
Time Frame: 90 days after the cell treatment
Change of NIHSS between pre- and post-treatment 90 days
90 days after the cell treatment
Early improvement of National Institutes of Health stroke scale (NIHSS)
Time Frame: 14 days after the cell treatment
≥5 points improvement or score of 0-2 on NIHSS score at 14 days after treatment
14 days after the cell treatment
Dichotomized modified Rankin scale (mRS)
Time Frame: 90 days after the cell treatment
mRS ≤2 at 90 days after treatment
90 days after the cell treatment
Change of modified Rankin scale (mRS)
Time Frame: 90 days after the cell treatment
Change of mRS between pre- and post-treatment 90 days
90 days after the cell treatment
Dichotomized modified Barthel index (mBI)
Time Frame: 90 days after the cell treatment
mBI ≥60 at 90 days after treatment
90 days after the cell treatment
Change of modified Barthel index (mBI)
Time Frame: 90 days after the cell treatment
Change of mBI between pre- and post-treatment 90 days
90 days after the cell treatment
Change of gross motor function
Time Frame: 90 days after the cell treatment
Change of Gross motor function (Motricity index and Fugl-Meyer assessment)between pre- and post-treatment 90 days
90 days after the cell treatment
Change of Fine motor function
Time Frame: 90 days after the cell treatment
Change of Fine motor function (Purdue Pegboard test and Box and block test) between pre- and post-treatment 90 days
90 days after the cell treatment
Change of Mobility
Time Frame: 90 days after the cell treatment
Change of Mobility (Functional ambulatory category and 10m-Gait speed) between pre- and post-treatment 90 days
90 days after the cell treatment
Change of mini-mental status exam (MMSE)
Time Frame: 90 days after the cell treatment
Change of MMSE between pre- and post-treatment 90 days
90 days after the cell treatment
Change of quality of life
Time Frame: 90 days after the cell treatment
Change of EuroQol 5d (EQ-5D) between pre- and post-treatment 90 days
90 days after the cell treatment
Safety outcome
Time Frame: During 90 days after the cell treatment
  1. Death: All causes of death
  2. Recurrence: Recurrent stroke or transient ischemic attack

  3. The immediate reaction:

    Allergic reactions (tachycardia, fever, skin eruption, leukocytosis) Local complications (hematoma or local infection at the site of bone marrow aspiration) Vascular obstruction (tachypnea, oliguria, or peripheral vascular insufficiency) Systemic complications (infections,laboratory findings).

  4. Long-term adverse effects possibly related to MSC treatment Tumor formation (physical examination, plain x-ray, f/u MRI at 90 days after treatment), Aberrant connections (newly diagnosed seizure or arrhythmia)
During 90 days after the cell treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploration of biomarkers
Time Frame: During 90 days after the cell treatment

SDF(stromal cell-derived factor)-1ɑ (chemokine) S100ß (protection and regeneration) HIF(Hypoxia-inducible factor)-1 (preconditioning) Circulating MSCs and MSC-derived microparticles (CD105-CXCR4(C-X-C chemokine receptor type 4)-PS(phosphoserine)) BDNF (Brain-derived neurotrophic factor) levels and it's polymorphism, and VEGF (Vascular endothelial growth factor) levels

Resting-state functional MRI & Diffusion tensor imaging
During 90 days after the cell treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pharmicell Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-10-047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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