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NEW THERAPY FOR SPINAL CORD INJURIES
Massachussettes-based company Total Re-Cord, Inc., an early-stage company founded for the specific purpose of developing and commercializing new therapies for neurodegenerative diseases, plans to begin clinical trials in early 2006 with a new treatment for patients with spinal cord injuries.
RMx™, Total ReCord’s lead product, is a new non-cellular, non-drug based class of biotherapeutics that draws on the body’s natural regenerative process to stimulate the growth of new Central Nervous System tissue. “RMx is a promising alternative to embryonic stem cells that may have significant potential in the treatment of spinal cord injuries,” says Dr. John McDonald, the Executive VP and Director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute.
RMx’s regenerative matrix is a new method of treatment for spinal cord injuries that has shown promising results in preclinical trials in animal models. Total ReCord has created RMx based on the principle of supressing certain wound healing processes that interfere with central nervous system (CNS) tissue Regeneration, while enhancing the desirable traits of these processes.
RMx first works to clean out the site of damaged tissue and allow for new cell growth. It then slows the development of scar tissue that can inhibit the regeneration of surviving axons while simultaneously promoting new blood vessel formation. Both of these processes are crucial for formation of new, healthy CNS tissue. Furthermore, RMx has certain stimulatory effects on the formation and elongation of new neurites. After this new tissue is grown, it can be trained to function in the body to restore movement, even weight-bearing steps in patients with spinal cord injuries.
In pre-clinical studies, animals that had experienced traumatic damage to their spinal cords and were initially completely paralyzed were soon able to move about after treatment with RMx. In most cases, they were able to make weight-bearing steps. Total ReCord is confident that human implants that have been successfully used in their animal studies will be effective in treating patients with spinal cord injuries. However, the extent of recovery that can be achieved with RMx in human patients will only become evident after the human clinical studies. RMx has also been found to have no toxic side-effects in animals.
Founder and CEO Jan-Eric Ahlfors is hopeful that following the first phases of human clinical trials, RMx will be placed on fast-track status for FDA approval and may soon be applied even to conditions that have kept patients permanently in wheelchairs for decades. Total ReCord’s innovations can potentially provide restored movement to victims of paralysis, stroke, and Multiple Sclerosis.
TREATMENTS FOR SCI VARY DEPENDING ON CAUSE OF INJURY
How patients are injured has a significant affect on how they are treated after a spinal cord injury. Those with auto coverage, particularly in states like Michigan with no-fault laws, typically receive more generous therapy and equipment benefits. People who are victims of violence or who are injured in sports accidents or falls often have no coverage for intensive therapy and don’t receive the modern equipment and other benefits patients with auto insurance get.
“The difference between auto accident survivors and victims of violence couldn’t be larger,” says Cathy Lysack, a Wayne State University associate professor of gerontology who is studying the disparities.
Here are two examples: Mario Chavez, Lincoln Park: Chavez, 29, has had to call and plead to get therapy, a wheelchair, and even replacement wheels for his chair. He was shot at 7:00 a.m. July 7, 2003, in downtown Detroit as he unloaded his truck. Carjackers stole his truck and crashed it a few blocks away.
Unable to work after his injury, Chavez lost his job as a heating and cooling mechanic and along with it, his Blue Cross & Blue Shield health insurance. His Medicaid insurance does not cover the intensive therapy or the surgery abroad that he’d like to have. Even the changes made to the home where he lives—such as adding a ramp—had to come out of his pocket, he says.
Last year, he received the first scholarship awarded by the Rehabilitation Institute of Michigan’s Center for Spinal Cord Recovery. Since he started therapy at the institute in Detroit last November, the former body builder says he has gained strength and more function 6 inches below the injury that paralyzed him from the waist down.
Cortny Hoffman, Temperance: Hoffman was injured in a 2002 auto accident. She has received more than a year of intensive therapy at Rehabilitation Institute. Her insurance has paid for it fully, at least up to now. The coverage allowed her to order a modern wheelchair and will help underwrite the cost of a home she is building with her mother outside Monroe.
