Harry McDaniel, 51, a Baltimore roofer, most likely would have been confined to a wheelchair the rest of his life if he hadn't been treated with an experimental drug that is derived from cow brains.
Yesterday, with the help of his forearm crutches, he moved out onto the Shock-Trauma auditorium floor at the University of Maryland Medical Center and walked, steadily and unhesitatingly, for a distance of about 16 feet.
McDaniel is one of seven UM patients from a group of 16 to have shown dramatic recovery in a unique study to see if treatment with purified bovine nerve cell membranes could limit the devastating impact of paralysis. Six patients now can walk with assistance from leg braces. The seventh has returned to normal.
Eighteen other patients received a placebo or inert drug. Of those, only one had a similar improvement.
Without the drug, all 34 patients in the study would have emerged from highway, diving and gunshot tragedies as paraplegics or quadriplegics -- totally dependent on others for care.
"It is clear that we can begin to change our thinking about spinal cord injury, to consider it a treatable disease, rather than an incurable one," said Fred H. Geisler, a medical doctor with a Ph.D., who conducted the study at the Shock-Trauma Unit.
The drug, GM-1 ganglioside, allowed paralyzed muscles to regain function instead of merely strengthening weak yet functioning muscles, according to the scientist.
"These differences were significant enough to have a major impact on the lives of many of these patients," said Geisler, who also is a clinical assistant professor in the UM surgery department and chief of neurosurgery at the Columbia Medical Plan.
No adverse side effects were observed from the test of the moderately priced drug. But, the researcher said a multicenter study involving 200 to 400 patients will be started soon to confirm the drug's clinical benefit and safety.
If the findings hold up, thousands could be helped, Geisler said. About 10,000 spinal cord injuries occur each year in the United States. The economic impact of spinal cord injuries is estimated at $4 billion each year. Most of the 90 percent who survive are young people.
Gangliosides circulate freely in the body but are particularly rich in the brain and spinal cord tissues of humans as well as other mammals.
GM-1 ganglioside apparently works "by making a small fraction of neurons that survive the injury grow or sprout better or by salvaging some of the neurons that might die," the researcher said. In many recent studies in animals, gangliosides have stimulated the growth of nerve cells and the regeneration of damaged nervous tissues.
Results of the study are published in today's New England Journal of Medicine.
McDaniel, who once followed tornadoes so he could repair church steeples, was injured in an auto accident in February 1987, he said.
"I was totally out of it. I could talk and that was it," he recalled at yesterday's UM news conference. "I could not move a finger, a hand or my head.
"Now, I can drive a car. I shaved this morning. I made a sandwich today but I can't cook a meal yet and I do a little bit of everything."
PD "One of the reasons I can't do as much as I would like to," said
McDaniel, "is that I have one hand that won't straighten out and another that won't bend. If I had hands, I would walk out of here."
GM-1 ganglioside, which can be used only with a special permit obtained from the U.S. Food and Drug Administration, was first given within 72 hours of the patients' injuries, followed by daily injections for 18 to 32 days. The patients were evaluated for one year after treatment.
Last year, another drug -- methylprednisolone -- was shown to produce a beneficial effect in treating spinal cord injury, too. Although the two studies initially appear to be closely related, the journal's report says they actually differed substantially and cannot be directly compared.
"These drugs are active in separate phases of recovery and are believed to work by different mechanisms," he said. "It is conceivable that one day they could be used together or with other drugs to obtain even better recovery."
Meanwhile, Judith Walker, a San Francisco-area scientist, has applied for an investigational permit to use MG-1 ganglioside as a treatment for rehabilitated spinal cord-injured patients who have reached a plateau in their recovery.
"We have provided her with the drug and I think she may be starting her study within a month or so," said Dr. Frank C. Dorsey of the Fidia Pharmaceutical Corp. in Washington, which sponsored the UM study.