Overview

This trial is active, not recruiting.

Condition spinal cord injury
Sponsor North Shore Long Island Jewish Health System
Start date May 2009
End date August 2017
Trial size 287 participants
Trial identifier NCT00919581, 0268

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
MIF
time frame: 2

Secondary Outcomes

Measure
inflammatory mediators
time frame: 2

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury
Principal investigator Ona Bloom, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by North Shore Long Island Jewish Health System.