Pilot Study: The Role of Migration Inhibitory Factor (MIF) in Spinal Cord Injury - Full Text View

Sponsor:	North Shore Long Island Jewish Health System
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00919581

Purpose

The purpose of this study is to evaluate substances that may be present in the blood after a spinal cord injury (SCI). Specifically, the study will evaluate the presence and levels of a protein, macrophage migration inhibitory factor (MIF), in the blood of patients who have had a SCI. Blood samples from patients who have had a SCI and healthy individuals will be studied to measure MIF levels. 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 spinal cord injury patients and normal healthy individuals, the investigators will try to find out if MIF levels are increased in people with SCI. Investigators will also use these samples 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 will help improve the treatment of SCI in the future.

We hope to enroll a total of 75 subjects in this study (50 with spinal cord injury, 25 healthy individuals).

Condition
Spinal Cord Injury

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Pilot Study: The Role of MIF in Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

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

Estimated Enrollment:	75
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (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 from the subjects medical record. The subjects will also have blood drawn (approximately 1 tablespoon) once in the morning and once in the evening. Whenever possible, this blood will be collected at the time of a regularly scheduled blood draw so no extra "stick" will be needed. It is possible if the doctor treating the SCI orders a spinal tap be done as a part of routine medical care, that one or two drops of the fluid that surrounds the spinal cord that would have been discarded, will instead be kept for analysis

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, healthy 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-E 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 (confirmed by complete medical/surgical history, brief physical examination, laboratory blood tests, including complete blood count and comprehensive metabolic profile)

Exclusion Criteria:

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

< 18 years of age
No known SCI
Concurrent infection such as UTI

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

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

Contacts

Contact: Gulru Sharifova	516-562-1012	gsharifo@nshs.edu
Contact: Chrissy Demers	516-562-1012	cdemers@nshs.edu

Locations

United States, New York
General CLinical Research Center	Recruiting
Manhasset, New York, United States, 11030
Contact: Gulru Sharifova 516-562-1012 gsharifo@nshs.edu
Contact: Julie Martusciello 5165621012 jmartusc@nshs.edu
Principal Investigator: Ona Bloom, PhD

Sponsors and Collaborators

North Shore Long Island Jewish Health System

Investigators

Principal Investigator:

Ona Bloom, PhD

The Feinstein Institute for Medical Research

More Information

No publications provided

Responsible Party:	Ona Bloom, The Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier:	NCT00919581 History of Changes
Other Study ID Numbers:	0268
Study First Received:	June 10, 2009
Last Updated:	May 24, 2011
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
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 24, 2012