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Miami Project to Conduct Clinical Trials on Humans
Author: | Wednesday March 19, 2008
Announcement of clinical trials has Marc Buoniconti, President of the Miami Project, and others, hopeful of coming closer to a cure.
The Next Step
Human Clinical Trials at the Miami Project
Will Seek to Regenerate Damage Nerve Cells
Mark Buniconti is trying very hard to stay calm, but it is not easy. “For the first time I am having a difficult time not becoming emotional,” Buoniconti told an audience of rehabilitation nurses recently at a conference in Fort Lauderdale.
The reason for his excitement is the upcoming clinical trials directed at regenerating damaged spinal cord cells throught the transplantation of Schwann cells into human beings. Buoniconti, President of the Miami Project to Cure Paralysis has been an activist for research since he was injured playing football for the Citadel in 1985, resulting in his becoming a quadriplegic. With his father, Hall of Fame football player, Nick Buoniconti, Dr. Barth Green and others, the Miami Project to Cure Paralysis was founded.
Schwann cell transplants in laboratory experiments could support regeneration of damaged spinal cord nerve fibers according to a report in The Project, a Publication of the Miami Project to Cure Paralysis and the Buoniconti Fund to Cure Paralysis. “In 2004, Drs. Damien Pearse and Mary Bartlett Bunge, Ph.D., presented exciting results that showed significant walking recovery in animals with acute spinal cord injury when Schwann cell transplants were combined with injections of rolpram, a drug than enhances levels of the messenger molecule cyclic AMP,” according to the report. Schwann cells , are called the “helper cells“ that surround nerve cells in the peripheral nervous system.
This is a defining moment for the Project,” Marc Buoniconti said. “I will never accept this injury. I will deal with it, but will never accept it”, he emphasized. He indicated that the upcoming clinical trails represent the best chance for a cure that he has ever seen. “We will be starting with paraplegics because there is less chance of complications,” he noted. The trials will begin with ten individuals late this year or in early 2009, he indicated.
There are many technical details that have to be worked out with the FDA and the Miami Project is working to make sure every requirement is fulfilled in a timely manner, Buoniconti said.
He also told the nurses about studies are ongoing reqarding the cooling of the nervous system in individuals with acute spinal cord injury. New technology has allowed researchers to use state-of-the-art equipment to precisely lower body temperatures. According to the report in “The Project” clinicl trials have recently showned hypothermia can be beneficial in patients with brain injuries and heart attacks while evaulations of the benefits to spinal cord injured persons has yet to be “evaluated properly.”
Buoniconti said all of the research takes money and lots of it to keep the doors of the Miami Project open, much less to advance research projects. “We raise $20 million a year just to keep in operation and sixty percent of that comes from private donations,” he added. Surprisingly, not as much comes from groups such as the National Football League as might be expected, but comes from fundraisers held by chapters across the country and other supporters.
Buoniconti said the Miami Project works with other organizations around the world including the Christopher Reeve Foundation founded by the late actor after Reeve was paralyzed when he fell off a horse during a jumping competition. “We don’t care who does it or where a cure comes from, as long is one is found,” he said.
As to some of the claims heard around the world, he noted, “I’m not stupid, if I knew there was a cure somewhere, I would be on the next plane to get it, but right now I believe we are on the right track. “
Ed. Note: If you would like to learn more about the Miami Project or the Buoniconti Fund to Cure Paralysis, visit www.thebuonicontifund.com or call the office at 305-243-4656 to learn how you can become involved in a search for a cure. Buoniconti was the keynote speaker at a recent conference of the Broward Association of Rehabilitation Nurses.
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