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

April 24, 2017 updated by: Ona Bloom, Northwell Health

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).

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Feinstein Institute for Medical Research, Northwell Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with spinal cord injury, uninjured controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Healthy controls
Subjects with spinal cord injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MIF
Time Frame: 2
macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine
2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory mediators
Time Frame: 2
circulating inflammatory mediators
2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Ona Bloom, PhD, The Feinstein Institute for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0268

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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