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Stroke, IschemicPhase 3STARTING-2NCT01716481

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

A Phase 3 study testing Mesenchymal stem cell in people with Stroke, Ischemic, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Stroke, Ischemic
What is being tested?
Mesenchymal stem cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
Nov 2012to Dec 2017
Phase
Phase 3
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women (women must be of non-child bearing potential), age 30-75 yrs.
  • Have a stroke that is observed within 90 days of the onset of symptoms
  • Radiologically
  • Relevant lesions within the middle cerebral artery territory (MCA) as assessed using diffusion-weighted imaging (DWI).
  • The maximum diameter of the stroke region in any dimension must be ≥15 mm.
  • Not involving more than a half of the ipsilateral periventricular zone
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  • Clinically (National Institutes of Health stroke scale, NIHSS)
  • Moderate-to severe persistent neurologic deficit (NIHSS of 6-21 inclusive)
  • 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.
  • Must be alert or drowsy but easily arousable as defined by score of 0-1 on the NIHSS Level of Consciousness question (item 1).
  • "Slow recovery" defined as Change in NIHSS ≤1 point/3 days
  • Willingness
  • Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits.
  • Able to participate in the evaluation process to the point of accurate assessment.
  • Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures.
  • Evidence of a personally signed and dated informed consent document.

Who cannot join

  • 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.
  • Have a stroke that is either
  • lacunar infarction
  • Hematologic cause of stroke
  • Recurrent or progressive stroke within 1 week at the time of screening.
  • Hematologic disorders or bone marrow suppression.
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  • Have a severe medical illness
  • Severe heart failure
  • Severe febrile illness
  • Hepatic or renal dysfunction
  • Active cancer
  • 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.
  • Presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis on admission blood tests
  • 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.
  • Presence of dementia prior to the current stroke that is likely to confound clinical evaluation.
  • Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test or lactating females.
  • Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol
  • Subjects unwilling to undergo bone marrow aspiration

Trial locations and contacts

1 site in 1 country.

Oh Young Bang, MD contact

82-10-3410-3599

nmboy@unitel.co.kr

Sang Ae Park, RN contact

82-10-3410-0934

sa0124.park@samsung.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul, 135710

    Suk Jae Kim, MD, 82-2-3410-1895, sukjae.kim@gmail.com

    Oh Young Bang, MD

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Mesenchymal stem cell
Keywords
Stroke, Mesenchymal stem cells, Stem cells, Neurogenesis
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

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

  • Mesenchymal stem cellOther

    intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum

Study groups in NCT01716481
Study groupRoleWhat they receive
Mesenchymal stem cell treatmentExperimentalNot described
Receives: Other: Mesenchymal stem cell
Standard treatmentNo interventionNot described

What is being measured

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

  1. Categorical shift in modified Rankin scale (mRS)

    Categorical shift in mRS at 90 days after the cell treatment

    Measured: 90 days after the cell treatment

Secondary outcomes (12)

  1. Change of National Institutes of Health stroke scale (NIHSS)

    Change of NIHSS between pre- and post-treatment 90 days

    Measured: 90 days after the cell treatment

  2. Early improvement of National Institutes of Health stroke scale (NIHSS)

    ≥5 points improvement or score of 0-2 on NIHSS score at 14 days after treatment

    Measured: 14 days after the cell treatment

  3. Dichotomized modified Rankin scale (mRS)

    mRS ≤2 at 90 days after treatment

    Measured: 90 days after the cell treatment

  4. Change of modified Rankin scale (mRS)

    Change of mRS between pre- and post-treatment 90 days

    Measured: 90 days after the cell treatment

  5. Dichotomized modified Barthel index (mBI)

    mBI ≥60 at 90 days after treatment

    Measured: 90 days after the cell treatment

  6. Change of modified Barthel index (mBI)

    Change of mBI between pre- and post-treatment 90 days

    Measured: 90 days after the cell treatment

  7. Change of gross motor function

    Change of Gross motor function (Motricity index and Fugl-Meyer assessment)between pre- and post-treatment 90 days

    Measured: 90 days after the cell treatment

  8. Change of Fine motor function

    Change of Fine motor function (Purdue Pegboard test and Box and block test) between pre- and post-treatment 90 days

    Measured: 90 days after the cell treatment

  9. Change of Mobility

    Change of Mobility (Functional ambulatory category and 10m-Gait speed) between pre- and post-treatment 90 days

    Measured: 90 days after the cell treatment

  10. Change of mini-mental status exam (MMSE)

    Change of MMSE between pre- and post-treatment 90 days

    Measured: 90 days after the cell treatment

  11. Change of quality of life

    Change of EuroQol 5d (EQ-5D) between pre- and post-treatment 90 days

    Measured: 90 days after the cell treatment

  12. Safety outcome

    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)

    Measured: During 90 days after the cell treatment

Timeline

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

  1. First posted29 Oct 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716481
Sponsor's protocol ID
2011-10-047
Acronym
STARTING-2
Status last verified
Apr 2017
First submitted
25 Oct 2012
Last updated
26 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Bang OY, Kim EH, Cho YH, Oh MJ, Chung JW, Chang WH, Kim YH, Yang SW, Chopp M. Circulating Extracellular Vesicles in Stroke Patients Treated With Mesenchymal Stem Cells: A Biomarker Analysis of a Randomized Trial. Stroke. 2022 Jul;53(7):2276-2286. doi: 10.1161/STROKEAHA.121.036545. Epub 2022 Mar 28.

    PubMed 35341320

  • Lee J, Chang WH, Chung JW, Kim SJ, Kim SK, Lee JS, Sohn SI, Kim YH, Bang OY; STARTING-2 Collaborators. Efficacy of Intravenous Mesenchymal Stem Cells for Motor Recovery After Ischemic Stroke: A Neuroimaging Study. Stroke. 2022 Jan;53(1):20-28. doi: 10.1161/STROKEAHA.121.034505. Epub 2021 Sep 29.

    PubMed 34583525

  • Chung JW, Chang WH, Bang OY, Moon GJ, Kim SJ, Kim SK, Lee JS, Sohn SI, Kim YH; STARTING-2 Collaborators. Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke. Neurology. 2021 Feb 16;96(7):e1012-e1023. doi: 10.1212/WNL.0000000000011440. Epub 2021 Jan 20.

    PubMed 33472925

  • Kim SJ, Moon GJ, Chang WH, Kim YH, Bang OY; STARTING-2 (STem cell Application Researches and Trials In NeuroloGy-2) collaborators. Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial. Trials. 2013 Oct 1;14:317. doi: 10.1186/1745-6215-14-317.

    PubMed 24083670

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mesenchymal stem cell in people with Stroke, Ischemic, run by Samsung Medical Center 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 16 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Apr 2017. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Oh Young Bang, MD (82-10-3410-3599, nmboy@unitel.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Categorical shift in modified Rankin scale (mRS) (time frame: 90 days after the cell treatment). 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 NCT01716481, which also lists 4 linked publications.

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 26 Apr 2017.

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