FOR IMMEDIATE RELEASE October 25, 1999
CONTACT: Deia Lofendo (847) 518-2519 [email protected]
New Spinal Cord Cell Therapy May Help Paralyzed Patients Regain Use of Lost Body Functions
Autologous macrophage therapy for the regeneration of neurons damaged by physical trauma, is offering new hope for acute spinal cord injured patients. The therapy is expected to help individuals with debilitating motor dysfunction return to increasingly normal lives.
Valentin Fulga, MD, Director of Regulatory & Clinical Affairs of Proneuron Biotechnologies will report on the results of this novel treatment in preclinical animal studies at the 49th Annual Meeting of the Congress of Neurological Surgeons, on Monday, November 1, 1999.
This new spinal cord cell therapy, which has shown encouraging results in recent animal studies, was recently approved by the U.S. Food and Drug Administration (FDA) for a Phase I trial in humans. The trial, which will begin in November, will involve 6-10 new spinal cord injury patients at two medical centers in Israel. Initial signs of recovery are expected about nine to twelve months after receiving the therapy.
The principal investigators in the trial are Zvi Harry Rappaport, MD, Head of the Department of Neurosurgery at Rabin Medical Center; Moshe Hadani, MD, Chairman of the Neurosurgery Department at Sheba Medical Center; and Nachshon Knoller, MD, Senior Neurosurgeon at Sheba Medical Center.
"This procedure marks the first time that the FDA has approved a spinal cord cell therapy trial to try to help paralyzed patients regain the use of their limbs," said Dr. Rappaport.
The procedure works by taking white blood cells, known as macrophages, and processing them in a laboratory for approximately one day. The cells are then injected into the spinal cord at the site of injury.
Macrophages, which promote healing in most body tissues, are suppressed in the spinal cord thereby making cell regeneration impossible. However, therapeutic administration of active macrophages directly into the damaged spinal cord may overcome the suppressive environment and encourage nerve regeneration. The cell therapy, in order to be effective, must be started within two weeks of the injury.
Describing the potential impact of the therapy in humans, Dr. Hadani said, "For the first time, we might be able to regenerate spinal nerve tissue. This new modality has the potential to become a major breakthrough in the treatment of diseases of the central nervous system."
Approximately 450,000 people in the United States have sustained spinal cord injuries (SCI), with more than 10,000 new cases reported in the U.S. every year. Motor vehicle accidents are the leading cause of SCI (44 percent), followed by acts of violence (24 percent), falls (22 percent), sports injuries (8 percent), and other causes (2 percent).
The potential effect of autologous macrophages to induce CNS regeneration was discovered by Prof. Michal Schwartz at the Weizmann Institute of Science in Israel. The human therapy was developed by Proneuron Biotechnologies Inc., which is a company working to create technologies for the treatment of disorders of the human central nervous system.
Founded in 1951, the Congress of Neurological Surgeons (CNS) is a scientific and educational association with approximately 4,800 members worldwide. The CNS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. Neurological surgery is the medical specialty concerned with the diagnosis and treatment of patients with injury to, or diseases of, the brain, spine and peripheral nerves.
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Media Representatives: To view the online press room, visit http://www.neurosurgery.org/pubpages/news/cn99mediakit.html. If you would like to cover the meeting or interview a neurosurgeon - either on-site or via telephone - please contact Deia Lofendo at (847) 518-2519 or call the Annual Meeting press room at the meeting beginning Sunday, October 31, at (617) 954-2595.
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