Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury

NCT00919581 | Completed

• 1 other identifier: 0268
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury

Outcome Measures

Primary Outcomes (1)

• MIF

  macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine

  2

Secondary Outcomes (1)

• inflammatory mediators

  2

Study Arms (2)

Healthy controls

Subjects with spinal cord injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with spinal cord injury, uninjured controls

You may qualify if:

• ≥18 years of age
• History SCI (acute or chronic): All American Spinal Injury Association (ASIA) classifications A-D and all levels.
• ≥18 years of age
• The absence of any current or previous medical conditions

You may not qualify if:

• \< 18 years of age
• No known SCI
• Concurrent infection such as UTI
• Deep pressure sores
• cancer, chemotherapy or neutropenia
• autoimmune disease
• \< 18 years of age
• Current or previous medical conditions

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institute for Medical Research, Northwell Health

Manhasset, New York, 11030, United States

Location

Related Publications (2)

• 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.

  PMID: 25461821 BACKGROUND

• 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.

  PMID: 23618747 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ona Bloom, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 12, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (1)