Research Updates

Kessler Foundation Research Center Spinal cord injury (SCI) and its associated lost functions are devastating. For many people with SCI, the term “clinical trials” offer hope as a means to identify treatments that will restore many of these lost functions. This hope, however, also leaves people with SCI vulnerable to claims made by unproven treatments. The purpose of this article is to provide an overview of some of the resources available for people interested in SCI clinical trials.

What is a clinical trial? A clinical trial is a research study designed to answer specific questions about a new treatment or a new way of using current treatments. Clinical trials are used to establish the safety and effectiveness of new treatments. It is very important to understand that the new treatment may not be better or may even be worse than existing treatments. However, if the experimental treatment is shown to be both safe and effective, then it can become standard treatment. Clinical trials are carried out in a series of steps called phases. Each phase provides different information about a new treatment. Phase I of clinical trials is used to determine the safety of a new experimental treatment in a small group of people. Phase II of clinical trials provides more information on the safety of a new treatment and determines how well it works. Phase III of clinical trials compares the effectiveness and the safety of the new treatment with the standard treatment in a large group of people. Phase IV studies are done once an experimental treatment is approved for use. They monitor ongoing long-term safety and potential use in other populations.

What should I know if I am considering participating in a clinical trial? First, one should be cautious of unproven treatments claiming they can restore function if people are willing to pay. At times it may be difficult to tell the difference between a legitimate clinical trial and a treatment program that is claiming to be a trial. The International Collaboration on Repair Discoveries (ICORD; icord.org ) has produced an easy-to-read booklet addressing this and many other questions people have regarding clinical trials in SCI. A revised version of this booklet, Experimental treatments for spinal cord injury: What you should know was published in September 2012 and is available for download free at the ICORD website. This book is a must-read for anyone considering participation in an SCI clinical trial.

How does one find out about current SCI clinical trials? The Spinal Cord Outcomes Partnership Endeavor (SCOPE; www.scopesci.org) provides a table of current SCI clinical trials for interventions to improve neurological function. The mission of SCOPE is to enhance the development of clinical trials and clinical practice protocols that will validate therapeutic interventions for SCI and lead to improved best practices.

Another resource for clinical trials in SCI is ClinicalTrials.gov. ClinicalTrials.gov is a web-based registry of clinical trials on a wide range of conditions, including spinal cord injury (www.ClinicalTrials.gov; type in keyword, “spinal cord injury”). ClinicalTrials.gov lists not only SCI clinical trials for interventions to improve neurological function, but also those relating to other complications associated with SCI, such as pain, bowel and bladder dysfunction, spasticity, respiratory complications, etc. Although there is currently no cure for SCI, great advances have been made in a number of areas to improve function, prevent and treat medical complications, and improve overall quality of life. Clinical trials provide an opportunity to identify new treatments that are both safe and effective and that may someday be incorporated into standard practice in the care of people with SCI.

The Alan T Brown Foundation SCI Research Award
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New Clinical Care Research in SCI: Reduction of Muscle Wasting by Motoneuron Replacement
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Proneuron Expands Phase II Clinical Trial of Procord 
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