Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury
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).
Spinal Cord Injury
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury|
- MIF [ Time Frame: 2 ] [ Designated as safety issue: No ]macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine
- inflammatory mediators [ Time Frame: 2 ] [ Designated as safety issue: No ]circulating inflammatory mediators
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
|Subjects with 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919581
|Contact: Rachel Monahanemail@example.com|
|Contact: Ona Bloom, PhDfirstname.lastname@example.org|
|United States, New York|
|Feinstein Institute for Medical Research, NSLIJ-HS||Recruiting|
|Manhasset, New York, United States, 11030|
|Contact: Rachel Monahan 516-562-1331 email@example.com|
|Principal Investigator: Ona Bloom, PhD|
|Principal Investigator:||Ona Bloom, PhD||The Feinstein Institute for Medical Research|