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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Feinstein Institute for Medical Research, Northwell Health

Manhasset, New York, 11030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

SCI Subject Inclusion Criteria: To be eligible for prospective enrollment, subjects are required to meet the following inclusion criteria:

≥18 years of age
History SCI (acute or chronic): All American Spinal Injury Association (ASIA) classifications A-D and all levels.

Healthy Control Subject Inclusion Criteria: To be eligible for prospective enrollment, healthy control subjects are required to meet the following inclusion criteria:

≥18 years of age
The absence of any current or previous medical conditions

To be eligible for prospective enrollment, SCI subjects are required to not meet the following exclusion criteria:

< 18 years of age
No known SCI
Concurrent infection such as UTI
Deep pressure sores
cancer, chemotherapy or neutropenia
autoimmune disease

Healthy Control Subject Exclusion Criteria: To be eligible for prospective enrollment, healthy control subjects are required to not meet the following exclusion criteria:

< 18 years of age
Current or previous medical conditions

Treatment and study plan

Primary outcomes

MIF

Time frame: 2

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

Secondary outcomes

inflammatory mediators

Time frame: 2

circulating inflammatory mediators

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: Jun 12, 2009
Registry last updated: Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed