The STem Cell Application Researches and Trials In NeuroloGy-2 (STARTING-2) Study (STARTING-2)
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|ClinicalTrials.gov Identifier: NCT01716481|
Recruitment Status : Unknown
Verified April 2017 by Oh Young Bang, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : October 29, 2012
Last Update Posted : April 26, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Stroke, Ischemic||Other: Mesenchymal stem cell||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke: A Single Center, Randomized, Open Label, Prospective, Phase 3 Study|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
|Experimental: Mesenchymal stem cell treatment||
Other: Mesenchymal stem cell
intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum
|No Intervention: Standard treatment|
- 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
- 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
- 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
- Dichotomized modified Rankin scale (mRS) [ Time Frame: 90 days after the cell treatment ]mRS ≤2 at 90 days after 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
- Dichotomized modified Barthel index (mBI) [ Time Frame: 90 days after the cell treatment ]mBI ≥60 at 90 days after 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
- 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
- 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
- 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
- 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
- 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
- Safety outcome [ Time Frame: During 90 days after the cell treatment ]
- Death: All causes of death
- Recurrence: Recurrent stroke or transient ischemic attack
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).
- 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)
- 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
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|Ages Eligible for Study:||30 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716481
|Contact: Oh Young Bang, MDemail@example.com|
|Contact: Sang Ae Park, RNfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center, Sungkyunkwan University School of Medicine||Recruiting|
|Seoul, Korea, Republic of, 135710|
|Contact: Suk Jae Kim, MD 82-2-3410-1895 email@example.com|
|Principal Investigator: Oh Young Bang, MD|
|Sub-Investigator: Suk Jae Kim, MD|
|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|
|Sub-Investigator: Gyeong-Moon Kim, MD|
|Sub-Investigator: Chin-Sang Chung, MD|
|Sub-Investigator: Kwang Ho Lee, MD|
|Principal Investigator:||Oh Young Bang, MD||Samsung Medical Center|
|Responsible Party:||Oh Young Bang, Associate Professor, Samsung Medical Center|
|Other Study ID Numbers:||
|First Posted:||October 29, 2012 Key Record Dates|
|Last Update Posted:||April 26, 2017|
|Last Verified:||April 2017|
Mesenchymal stem cells
Central Nervous System Diseases
Nervous System Diseases