Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT00919581|
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : April 25, 2017
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).
|Condition or disease|
|Spinal Cord Injury|
During the study visit the investigator will collect basic biographical information and health information, including some questionnaires, from the subjects and their medical record.
Acute SCI subjects will also have blood drawn once daily (First blood draw will approximately be 2 tablespoons and subsequent blood draws will approximately be 1 tablespoon) .
Chronic SCI subjects will have blood drawn per study visit (approximately 2 tablespoons) and will be asked to participate in two study visits, to take place 6 months apart.
|Study Type :||Observational|
|Actual Enrollment :||149 participants|
|Official Title:||Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury|
|Study Start Date :||May 2009|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
|Subjects with spinal cord injury|
- MIF [ Time Frame: 2 ]macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine
- inflammatory mediators [ Time Frame: 2 ]circulating inflammatory mediators
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): NCT00919581
|United States, New York|
|Feinstein Institute for Medical Research, Northwell Health|
|Manhasset, New York, United States, 11030|
|Principal Investigator:||Ona Bloom, PhD||The Feinstein Institute for Medical Research|