NEW YORK, Nov 04 (Reuters Health) -- The first US Food and Drug Administration-approved clinical trial using autologous macrophage therapy in newly injured spinal cord patients will begin this month in Israel, according to a report presented this week at the 49th Annual Meeting of the Congress of Neurological Surgeons, held in Boston.
In this potential treatment, which has shown promise in animal studies, a specific type of white blood cells called macrophages are taken from the injured patient, processed, and then injected into the spinal cord at the site of the injury. The goal of the technique is to use macrophages to promote healing and regeneration of severed nerves in the damaged cord. Macrophages cannot naturally get to the site of spinal cord injury.
Dr. Nachshon Knoller of Sheba Medical Center in Tel Aviv, Israel, told Reuters Health that in preclinical studies "about 75% of animals showed nerve regeneration" following spinal cord injury using this technique.
Knoller and colleagues at Sheba Medical Center and at Rabin Medical Center in Tel Aviv, plan to treat up to 10 newly injured spinal cord patients to determine if autologous macrophage therapy will promote regeneration of nerve cells at the site of cord injury.
"Enrolling patients is very complex in this study," Knoller told Reuters Health. The patients, who will range in age from 18 to 65 years, must have a newly acquired blunt spinal injury between the fifth cervical and the tenth thoracic vertebrae. To be eligible, patients cannot be in spinal shock or have trouble breathing, Knoller explained.
"Every patient will receive standard treatments during the acute stage of their injury," Knoller said. All the patients will continue standard long-term therapy at the National Spinal Cord Injury Rehabilitation Center at Sheba Medical Center, he added.
Therapy must be initiated within 5 to 14 days of injury, Knoller said. If successful, the researchers expect regeneration to occur within 9 to 12 months following treatment.
"For the first time, we might be able to regenerate spinal nerve tissue," said Dr. Moshe Hadani, chairman of the Neurosurgery Department at Sheba Medical Center, in a statement. "This new modality has the potential to become a major breakthrough in the treatment of diseases of the central nervous system." The central nervous system includes the brain and spinal cord.
About 450,000 people in the US have spinal cord injuries, with more than 10,000 new cases each year. Motor vehicle accidents and violent attacks are the most common causes of such injuries, which can result in loss of sensation and paralysis of the legs or the arms and legs. Injuries to the spinal cord in the neck can also interfere with the patient's ability to breathe.