NCT01716481

Brief 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 patients receiving standard treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

5.1 years

First QC Date

October 25, 2012

Last Update Submit

April 24, 2017

Conditions

Stroke, Ischemic

Keywords

StrokeMesenchymal stem cellsStem cellsNeurogenesis

Outcome Measures

Primary Outcomes (1)

  • Categorical shift in modified Rankin scale (mRS)

    Categorical shift in mRS at 90 days after the cell treatment

    90 days after the cell treatment

Secondary Outcomes (12)

  • Change of National Institutes of Health stroke scale (NIHSS)

    90 days after the cell treatment

  • Early improvement of National Institutes of Health stroke scale (NIHSS)

    14 days after the cell treatment

  • Dichotomized modified Rankin scale (mRS)

    90 days after the cell treatment

  • Change of modified Rankin scale (mRS)

    90 days after the cell treatment

  • Dichotomized modified Barthel index (mBI)

    90 days after the cell treatment

  • +7 more secondary outcomes

Other Outcomes (1)

  • Exploration of biomarkers

    During 90 days after the cell treatment

Study Arms (2)

Mesenchymal stem cell treatment

EXPERIMENTAL
Other: Mesenchymal stem cell

Standard treatment

NO INTERVENTION

Interventions

Mesenchymal stem cellOTHER

intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum

Mesenchymal stem cell treatment

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135710, South Korea

RECRUITING

Related Publications (4)

  • 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.

    PMID: 35341320DERIVED

  • 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.

    PMID: 34583525DERIVED

  • 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.

    PMID: 33472925DERIVED

  • 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.

    PMID: 24083670DERIVED

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Oh Young Bang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oh Young Bang, MD

CONTACT

82-10-3410-3599nmboy@unitel.co.kr

Sang Ae Park, RN

CONTACT

82-10-3410-0934sa0124.park@samsung.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 25, 2012

First Posted

October 29, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

KR(1)