Spinal Cord InjuryNCT00919581
Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury
An observational study of Spinal Cord Injury, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with spinal cord injury, uninjured controls
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research, Northwell Health
Manhasset, New York, 11030
About this study
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).
Read the 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.
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described | |
| Subjects with spinal cord injury | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIF
macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine
Measured: 2
Secondary outcomes (1)
inflammatory mediators
circulating inflammatory mediators
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ona Bloom, Northwell Health
- Investigators
- Ona Bloom, PhD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919581
- Sponsor's protocol ID
- 0268
- Status last verified
- Apr 2017
- First submitted
- 10 Jun 2009
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bank M, Stein A, Sison C, Glazer A, Jassal N, McCarthy D, Shatzer M, Hahn B, Chugh R, Davies P, Bloom O. Elevated circulating levels of the pro-inflammatory cytokine macrophage migration inhibitory factor in individuals with acute spinal cord injury. Arch Phys Med Rehabil. 2015 Apr;96(4):633-44. doi: 10.1016/j.apmr.2014.10.021. Epub 2014 Nov 15.
PubMed 25461821Stein A, Panjwani A, Sison C, Rosen L, Chugh R, Metz C, Bank M, Bloom O. Pilot study: elevated circulating levels of the proinflammatory cytokine macrophage migration inhibitory factor in patients with chronic spinal cord injury. Arch Phys Med Rehabil. 2013 Aug;94(8):1498-507. doi: 10.1016/j.apmr.2013.04.004. Epub 2013 Apr 22.
PubMed 23618747
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00919581
- Acronym / sponsor ID
- 0268
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | – |
| Subjects with spinal cord injury | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with spinal cord injury, uninjured controls
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MIF
Time frame: 2
macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine
1 secondary outcome
inflammatory mediators
Time frame: 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Background: PubMed 25461821Bank M, Stein A, Sison C, Glazer A, Jassal N, McCarthy D, Shatzer M, Hahn B, Chugh R, Davies P, Bloom O. Elevated circulating levels of the pro-inflammatory cytokine macrophage migration inhibitory factor in individuals with acute spinal cord injury. Arch Phys Med Rehabil. 2015 Apr;96(4):633-44. doi: 10.1016/j.apmr.2014.10.021. Epub 2014 Nov 15.
- Results publication: PubMed 23618747Stein A, Panjwani A, Sison C, Rosen L, Chugh R, Metz C, Bank M, Bloom O. Pilot study: elevated circulating levels of the proinflammatory cytokine macrophage migration inhibitory factor in patients with chronic spinal cord injury. Arch Phys Med Rehabil. 2013 Aug;94(8):1498-507. doi: 10.1016/j.apmr.2013.04.004. Epub 2013 Apr 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ona Bloom, PhD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIF (time frame: 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.