NCT00919581|Completed
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Sponsor study identifier
observational
149
1 country
1
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)The purpose of the study is to investigate inflammatory and other substances that may be elevated in the blood and blood cells following spinal cord injury (SCI). These substances will be evaluated in samples from people who have had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first week (acute) or at least one year ago (chronic). Specifically, the study will evaluate the presence and levels of a protein, macrophage migration inhibitory factor (MIF). MIF is released by cells and has a specific effect on the way cells behave, communicate and work together. In several other medical conditions, MIF is known to increase inflammation in the body. By comparing blood samples from individuals with spinal cord injury and uninjured (no spinal cord injury) individuals, the investigators will try to find out if MIF levels are increased in people with SCI. Investigators will also use these samples to measure other proteins that increase inflammation in the body and to see if the biological activities of MIF can be reduced in a test tube by adding other substances to the blood samples. It is hoped that this study of MIF and other proteins related to inflammation will help improve the treatment of SCI in the future. We hope to enroll a total of 312 subjects in this study (50 with acute spinal cord injury, 125 with chronic spinal cord injury, and 137 uninjured individuals).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 10, 2009
Actual (reported)June 12, 2009
Actual (reported)December 2016
Actual (reported)December 2016
Actual (reported)MIF
macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine
2
inflammatory mediators
2
Subjects with spinal cord injury, uninjured controls
Feinstein Institute for Medical Research, Northwell Health
Manhasset, New York, 11030, United States
Bank M, Stein A, Sison C, Glazer A, Jassal N, McCarthy D, Shatzer M, Hahn B, Chugh R, Davies P, Bloom O. Elevated circulating levels of the pro-inflammatory cytokine macrophage migration inhibitory factor in individuals with acute spinal cord injury. Arch Phys Med Rehabil. 2015 Apr;96(4):633-44. doi: 10.1016/j.apmr.2014.10.021. Epub 2014 Nov 15.
Stein A, Panjwani A, Sison C, Rosen L, Chugh R, Metz C, Bank M, Bloom O. Pilot study: elevated circulating levels of the proinflammatory cytokine macrophage migration inhibitory factor in patients with chronic spinal cord injury. Arch Phys Med Rehabil. 2013 Aug;94(8):1498-507. doi: 10.1016/j.apmr.2013.04.004. Epub 2013 Apr 22.
Ona Bloom, PhD
Northwell Health
149 participants (actual enrollment reported by the registry).
First Submitted
June 10, 2009
First Posted
June 12, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Autologous Stem Cells for Spinal Cord Injury (SCI) in Children
Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
April 25, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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