|
Department of Defense gives $5.4 million to spinal cord injury research Read more...
NEWS UPDATE - April 13, 2010: The Reeve Foundation's North American Clinical Trials Network (NACTN) enrolled the first patient into its Riluzole Phase I safety study yesterday evening. NACTN, which is supported by a grant from the Department of Defense, has spent months planning and preparing for this clinical trial. This is an acute injury trial, which means that only patients who are newly injured, treated in the Emergency Room at a NACTN site and meet the inclusion/exclusion criteria can be enrolled.
Riluzole, a neuroprotective drug, is presently used in the treatment of amyotrophic lateral sclerosis where it prolongs the life spans of patients. It acts by blocking the ability of sodium and calcium ions to enter and damage neurons and glia. Laboratory studies have shown it to be effective in limiting traumatic damage to the spinal cord.
The Phase I study will evaluate safety of riluzole in acutely injured spinal cord patients; it will also investigate its pharmacodynamics (biochemical and physiological effects) and pharmacokinetics (what the body does to it). The trial will also collect information about its efficacy as measured by ASIA (motor and sensory outcomes), ASIA Impairment Grade and Brief Pain Inventory.
The riluzole protocol is unique in several ways: (1) the detail with which possible adverse effects of the therapy will be studied and (2) the use of pharmacokinetic and pharmacodynamic data and its correlation with adverse effects and efficacy. Previous studies of drug therapies for SCI have not measured blood and cerebrospinal fluid levels to see if effective or toxic levels of the drug were reaching the spinal cord and brain.
This Phase I is a multi-site, single arm, active treatment pilot study involving 36 subjects. Presently, 5 NACTN sites can enroll patients; the other 3 clinical sites are in the process of fulfilling their final regulatory requirements. If the rate of adverse effects in the initial trial group is not greater than that expected in comparison with the NACTN data registry, a Phase II study of a larger number of patients will be undertaken as an efficacy trial.
To participate in the study patients must:
- be between 18 and 70 years of age
- be willing to give written informed consent
- have no other life-threatening injury
- have a spinal cord injury at the neurologic level from C4 to T12
- have an ASIA Impairment Scale level A, B or C
- be able to receive Riluzole within 12 hours post-injury.
As with all clinical trials, there are exclusion criteria that apply. These include pregnancy or breast-feeding, substance abuse, a penetrating spinal cord injury or hypersensitivity to rilzuole or any of its components.
Download the new NACTN brochure.
A support system for clinical trials: accelerate and validate
When therapies are ready for human trials, where do they go?
The North American Clinical Trials Network (NACTN) is one more way that the Reeve Foundation is moving promising therapies from the lab to spinal cord injured patients. NACTN is working hard to insure that any clinical trial will be done in a way that maximizes both patient safety and our ability to gather valid, meaningful data.
NACTN is an international network of hospitals with highly trained personnel and uniform protocols and data collection that help to ensure safety for all trial subjects and interpretable trial data. NACTN is:
- Gathering and documenting patient medical information in a data registry to better understand the body’s natural course of recovery after injury. This information will allow us to more accurately identify improvement that results from the therapy being tested
- Using standardized patient assessment protocols and developing new ones
- Primed to conduct new trials of therapy for spinal cord injury
Expediting effective trials
Now, when researchers get the go-ahead for human trials, they don’t have to build the support system for such studies from the ground up – NACTN has already built the standing infrastructure.
Casting the widest net possible
Our immediate future plans include expanding NACTN to new clinical centers. We have begun a Neurological Outcomes Assessment initiative to develop new, more sensitive measures of function for spinal cord injury, and we are working with similar clinical networks in Europe and Canada to accomplish this goal. We also received a multi-million dollar grant from the U.S. Department of Defense to expand these important efforts to military, Veterans Administration, and select civilian hospitals.
NACTN Mission
NACTN Sites
NACTN Resources
NACTN Mission
The mission of the North American Clinical Trials Network for the Treatment of Spinal Cord Injury is to bring promising therapies out of the laboratory and into clinical trials, in a manner that provides incontrovertible evidence of effectiveness and safety. The North American group is collaborating with a similar network in Europe, and one just now forming in Canada, to define the natural history of spinal cord injury and develop measures for assessing treatment success. It is hoped that these collaborations will provide the foundation for a global network that will speed therapeutic development and ensure that powerful new therapies will be made available to those in need.
NACTN will also work closely with the Reeve Foundation Individual Research Consortium on Spinal Cord Injury to ensure an ongoing dialogue between laboratory researchers and clinicians. Through workshops and other educational programs, Consortium scientists will have the opportunity to network with clinical specialists from across North America and Europe, facilitating educational exchanges and iterative discussions about the development of effective treatments for spinal cord injury.
NACTN Sites
At the present time, the Reeve Foundation North American Clinical Trials Network is based at nine clincial centers in the U.S. and Canada. The tenth center is responsible for data analysis and management.
University of Miami, Miami, FL
Principal Investigator:
James Guest, M.D.
Thomas Jefferson University, Philadelphia, PA
Principal Investigator:
James Harrop, M.D.
The Methodist Hospital, Houston, TX
Principal Investigator:
Robert G. Grossman, M.D.
University of Louisville, Louisville, KY
Principal Investigators:
Susan Harkema, Ph.D.
Richard Hodes, M.D.
University of Maryland Medical System, Baltimore, M.D.
Principal Investigator:
Bizhan Aarabi, M.D.
University of Texas Health Science Center, Houston, TX
Principal Investigator:
Michele Johnson, M.D.
University of Toronto, Toronto, ON
Principal Investigators:
Charles Tator, M.D.
Michael G. Fehlings, M.D., Ph.D.
University of Virginia, Charlottesville, VA
Principal Investigators:
John Jane, M.D., Ph.D.
Christopher Shaffrey, M.D.
Walter Reed Army Medical Center, Washington, DC
Principal Investigator:
Michael K. Rosner, M.D., LTC, MC, USA
University of Texas School of Public Health, Houston, TX
Principal Investigator: Ralph Frankowski, Ph.D.
Data Management Center and Statistical Coordinating Center
NACTN Resources
With spinal cord clinical trials already underway in the U.S. and many more to come in the next few years, there is an urgent need to build bridges among researchers and pave the way for accelerated progress. These websites provide up-to-date information on current trials, discussion-based workshops, and other initiatives that seek to define guidelines and standards.
- Search for a Clinical Trial
The Christopher and Dana Reeve Foundation was one of the founding members of the International Campaign for Cures of Spinal Cord Injury Paralysis (ICCP). We, along with our ICCP colleagues, believe the ICCP Guide for Experimental Treatments for Spinal Cord Injury
is a crucial resource for people living with spinal cord injury, their families and their caregivers.
In today's wired world, there is a wealth of information available about treatments, proven and unproven, for the paralysis and other dysfunctions that result from a traumatic injury to the spinal cord and it is oftentimes challenging to separate the wheat from the chaff. The Reeve Foundation hopes that readers of these guidelines will be empowered to think critically about potential therapies for spinal cord injury and pose the important questions that should be asked.
Resource information on stem cell therapy
- ICCP Guide for Experimental Treatments for Spinal Cord Injury
- Guidelines: Clinical Translation of Stem Cells (International Society for Stem Cell Research)
- Patient Handbook on Stem Cell Therapies from the ISSCR
Report of the International Clinical Trials Workshop on Spinal Cord Injury: click here to download the PDF or view the report in your browser
This paper discusses information presented at the International Clinical Trials Workshop on Spinal Cord Injury, held in Vancouver, Canada in February 2004.
Reprinted by permission from Spinal Cord (citation below), copyright 2004, Macmillan Publishers Ltd.
Report of International Clinical Trials Workshop on Spinal Cord Injury February 20-21, 2004, Vancouver, Canada, Spinal Cord 2004;42(10):591-597.
ClinicalTrials.gov: http://clinicaltrials.gov/ct/gui/c/b
Search for federally and privately supported clinical trials.
NIH Roadmap: http://nihroadmap.nih.gov
Learn about the National Institutes of Health's "roadmap" for research in the 21st century. The site identifies major opportunities and gaps in biomedical research.
NINDS Workshop: Translating Promising Strategies for Spinal Cord Injury Therapy: http://www.ninds.nih.gov/news_and_events/proceedings/sci_translation_workshop.htm
Read about this discussion-based workshop that took place in 2003 that brought together leaders of major North American research groups that focus on SCI research.
Download the new NACTN brochure.
|
