Pilot Study: The Role of Migration Inhibitory Factor (MIF) in Spinal Cord Injury
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Purpose
The purpose of this study is to evaluate substances that may be present in the blood and blood cells 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 uninjured (no SCI) 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 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 MIF in Spinal Cord Injury |
- MIF [ Time Frame: 2 ] [ Designated as safety issue: No ]macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine
- 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: | December 2015 |
| Estimated Primary Completion Date: | November 2013 (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 and their medical record. Acute SCI 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. Chronic SCI subjects will have blood drawn (approximately (approximately 1 tablespoon) at study visit.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects with spinal cord injury, healthy controls
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| Contact: Chrissy Demers | 516-562-1012 | cdemers@nshs.edu |
| Contact: Ona Bloom | 516-562-3839 | obloom@nshs.edu |
| United States, New York | |
| Feinstein Institute for Medical Research, NSLIJ-HS | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Chrissy Demers 516-562-1012 cdemers@nshs.edu | |
| Principal Investigator: Ona Bloom, PhD | |
| Principal Investigator: | Ona Bloom, PhD | The Feinstein Institute for Medical Research |
More Information
No publications provided
| 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: | May 23, 2013 |
| 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 June 17, 2013