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



Status:Completed
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:4/26/2017
Start Date:May 2009
End Date:December 2016

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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).

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.

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
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