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
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Recruiting
First Posted
: October 29, 2012
Last Update Posted
: April 26, 2017
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Tracking Information | |||||||||
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First Submitted Date ICMJE | October 25, 2012 | ||||||||
First Posted Date ICMJE | October 29, 2012 | ||||||||
Last Update Posted Date | April 26, 2017 | ||||||||
Study Start Date ICMJE | November 2012 | ||||||||
Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01716481 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE |
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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Original Other Outcome Measures ICMJE | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The STem Cell Application Researches and Trials In NeuroloGy-2 (STARTING-2) Study | ||||||||
Official Title ICMJE | Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke: A Single Center, Randomized, Open Label, Prospective, Phase 3 Study | ||||||||
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. | ||||||||
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 ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Stroke, Ischemic | ||||||||
Intervention ICMJE | Other: Mesenchymal stem cell
intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum |
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Study Arms |
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Publications * | 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. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date | December 2017 | ||||||||
Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 30 Years to 75 Years (Adult, Senior) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Korea, Republic of | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01716481 | ||||||||
Other Study ID Numbers ICMJE | 2011-10-047 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | Oh Young Bang, Samsung Medical Center | ||||||||
Study Sponsor ICMJE | Samsung Medical Center | ||||||||
Collaborators ICMJE | Pharmicell Co., Ltd. | ||||||||
Investigators ICMJE |
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PRS Account | Samsung Medical Center | ||||||||
Verification Date | April 2017 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |