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Participating in CCSVI clinical trials

Overview
How Clinical Trials Help Ensure Your Safety
How Clinical Trials Advance CCSVI for Others
Clinical Trials Currently Seeking Participants

 

Overview

Several options are now available for patients interested in participating in a CCSVI clinical trial.

Participating in a clinical trial helps ensure that you receive safe and humane testing and treatment. Further, participating in clinical trials advances the CCSVI cause for others, allowing researchers to better understand and improve CCSVI technologies and treatment.

In addition, patients may be interested in participating in trials related to CCSVI that examine cerebral blood flow (CBF), perfusion, vascular markers, and/or cerebral spinal fluid (CSF).

Please note:  information on this page applies only to Clinical Trials in the United States.

 

How Clinical Trials Help Ensure Your Safety

Generally, clinical trials are scientific studies that have been reviewed and approved by an advisory panel called an “Institutional Review Board,” or “IRB.”  While different types of IRBs have slightly different procedures and responsibilities, all IRBs are designed to ensure that clinical trials are run in a manner that ensures the ethical and humane treatment of all human subjects.

IRB approved clinical trials generally fall into two types:

  1. National Institute of Health (NIH) Registered Trials
  2. NIH registered clinical trials must conform to an extensive set of regulations and guidelines covering most aspects of the trial, including the ethical treatment of human subjects, use of appropriate scientific methodologies, trial sponsorship, and availability of trial outcome data. Details of these regulations can be found at the Health and Human Services Office of Human Research Protections.

  3. Clinical Trials Sponsored by Educational Institutions and Hospitals
  4. Virtually all educational institutions and hospitals have an IRB designed to review and monitor clinical trials. Educational and hospital sponsored clinical trials may or may not be registered with the NIH, but, because these institutions have experienced IRBs, patients have some assurance that ethical and humane practices are being followed. Educational institutions and hospitals often adopt some or many NIH guidelines on ethical treatment of human subjects. Moreover, educational institutions and hospitals often either post their IRB practices on-line or make them available upon request.

While IRB approval cannot guarantee absolute patient safety (nothing can) during clinical trials, IRB approved trials are nonetheless far preferable to treatment in facilities that have undergone no independent review at all.

In addition, clinical studies of significant risk medical devices, such as in the case of balloon angioplasty devices and stents to treat CCSVI, also require approval through the U.S. Food & Drug Administration (FDA)'s Investigational Device Exemption (IDE) program.

For further information on the FDA's IDE program, as well as the potential risks and need for further research into CCSVI, please see the FDA's Safety Communication on CCSVI Treatment in MS Patients as well as the Society of Interventional Radiology (SIR)'s response.



How Clinical Trials Advance CCSVI for Others

IRB approved CCSVI clinical trials may be designed to test and validate (or invalidate) all aspects of CCSVI, including diagnosis, theory, or treatment.

Results from IRB approved trials are eligible to be posted in the NIH database of trial results, which is available to the public and to other researchers1

The publication of scientifically valid CCSVI clinical trial data is essential to scientists and physicians looking to understand and improve CCSVI diagnosis and treatment. Without this data, CCSVI investigation may become fragmented and non-standard, and the results of CCSVI treatments will remain uncertain.

 

Clinical Trials Currently Seeking Participants

CCSVI Alliance understands the urgent need some patients have for receiving immediate CCSVI testing and treatment. However, for the reasons cited above, we encourage patients to get tested and (if necessary) treated in a clinical trial setting whenever possible.

Currently available CCSVI clinical trials include:

Type

Title

Trial Sponsor

Contact

Location

Study Details

 

 

 

 

 

 

 

Related Clinical Trials Currently Seeking Participants


These trials do not involve diagnosis or treatment of CCSVI, but are studies related to serum markers, cerebral perfusion and cerebral blood flow. Understanding how blood and cerebrospinal fluid travel through the brain will help further CCSVI research.


Currently available clinical trials include:

Type

Title

Trial Sponsor

Contact

Location

Study Details

Observational


(perfusion)

Comparing Lesion Contrast With Both Magnevist and Gadavist and Understanding the Cerebral Perfusion Patterns of Patients With Multiple Sclerosis (MS) Using Magnetic Resonance Imaging (MRI)

Wayne State University

Principal: E.Mark Haacke

Anamika Chaudhary, M.S
Phone: 313-745-1378 or
This email address is being protected from spambots. You need JavaScript enabled to view it.

Kingsley J. Yang, PhD
Phone: 313-933-8771 or
This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Detroit, MI

ClinicalTrials.gov Identifier:
NCT01836055

 

click for details

Footnotes

1. Most NIH registered clinical trials are required to post results data; IRB-approved but non-NIH registered trials still have the opportunity to post results though they may not be required to do so; non-IRB approved experiments cannot post in the NIH database).

 

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