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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by North Shore Long Island Jewish Health System
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Ona Bloom, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00919581
First received: June 10, 2009
Last updated: July 13, 2014
Last verified: July 2014
  Purpose

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 287 subjects in this study (25 with acute spinal cord injury, 125 with chronic spinal cord injury, and 137 uninjured individuals).


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • MIF [ Time Frame: 2 ] [ Designated as safety issue: No ]
    macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine


Secondary Outcome Measures:
  • inflammatory mediators [ Time Frame: 2 ] [ Designated as safety issue: No ]
    circulating inflammatory mediators


Estimated Enrollment: 287
Study Start Date: May 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy controls
Subjects with spinal cord injury

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 (approximately 1 tablespoon) once in the morning and once in the evening.

Chronic SCI subjects will have blood drawn (approximately 2 tablespoons) per study visit and will be asked to participate in two study visits, to take place 6 months apart.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with spinal cord injury, uninjured controls

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919581

Contacts
Contact: Rachel Monahan 516-562-3812 rmonahan1@nshs.edu
Contact: Ona Bloom, PhD 516-562-3839 obloom@nshs.edu

Locations
United States, New York
Feinstein Institute for Medical Research, NSLIJ-HS Recruiting
Manhasset, New York, United States, 11030
Contact: Rachel Monahan    516-562-3812    rmonahan1@nshs.edu   
Principal Investigator: Ona Bloom, PhD         
Sponsors and Collaborators
North Shore Long Island Jewish Health System
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Ona Bloom, PhD The Feinstein Institute for Medical Research
  More Information

Publications:
Responsible Party: Ona Bloom, Assistant Investigator, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00919581     History of Changes
Other Study ID Numbers: 0268
Study First Received: June 10, 2009
Last Updated: July 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 27, 2014