Acute spinal cord injury is an unexpected, catastrophic event, the consequences of which often persist for the life of the patient. The incidence of spinal cord injury in the U.S. is over 10,000 cases per year.
A study in 1991 reported in the New England Journal of Medicine reported the results of a prospective, randomized, placebo-controlled, double-blind drug trial of GM-1 ganglioside in patients with spinal cord injuries, with a follow-up period of one year after the injury to assess recovery. The ganglioside used in the study was Sygen supplied by Fidia Laboratories.
The study was claimed by the authors as representing a dramatic increase in neurologic function, with the majority of the patients changing from paralyzed to ambulatory status.
The marked improvement in the recovery of paralyzed motor groups, along with the similar recovery of the paretic muscles in the two treatment groups, indicated that the observed effect of GM-1 occurs by conversion of motor groups initially paralyzed into those with useful motor functions after one year. The study concluded that GM-1 is safe to administer in spinal cord injury and enhances the recovery of neurologic function after one year, but a larger study should be conducted to confirm its clinical benefit and safety.
In response to the publication of the research study, a letter in the New England Journal of Medicine argued against the efficacy of GM-1 (Sygen) of the Fidia Pharmaceutical Corporation and noted that the study failed to show any improvement in motor function after spinal cord injury.Questions
Has GM-1 Ganglioside been approved by the FDA?
What are the risks?
What is the cost?