Feb. 11, 1999 NASHVILLE -- Researchers who have pioneered a technique of transplanting laboratory-grown neuronal cells into the brains of stroke patients say that the procedure has been performed in seven patients, and some of those patients report that the therapy may have helped to restore motor and speech skills that otherwise would have been lost forever.
Scientists at the University of Pittsburgh Medical Center have treated seven stroke survivors with the therapy, and they reported results from their research Feb. 4 at the 24th American Heart Association International Conference on Stroke and Cerebral Circulation.
"At this point, we're trying to evaluate if its feasible to put these cells into the brain and whether the process is safe," says the study's lead author, Douglas Kondziolka, M.D., professor of neurological surgery and radiation oncology, University of Pittsburgh School of Medicine. "To this date, it has been safe and there have been no problems noted. That's been encouraging and the most important thing is hopefully this will lead to a larger second study."
Of the seven patients who have been treated, all have been able to leave the hospital within 24 hours and three have noticed small improvements in motor skills, says Kondziolka. The patient who received the first transplant -- a 62-year old woman who suffered a major stroke in the fall of 1997 -- has felt well over the first seven months and has had slight improvements in speech, according to Kondziolka.
"An important part of the research is that this is setting the foundation for a possible future treatment," says Kondziolka. "It's like in baseball -- you don't walk up to bat your first time and try to hit a home run. If you can walk, and get on base, you can set the stage for something bigger later."
In the current study, researchers are examining men and women between the ages of 40-75 who have had a stroke from six months to six years prior to the treatment in order to determine whether or not they can get motor skills to return through transplantation.
Currently, the only option available to most stroke survivors is intensive rehabilitation in order to recover lost motor skills. This led scientists to try a more radical approach -- direct transplantation of neurons into the brain in the hopes that the new cells would link with other cells in the same area to help restore speech and movement. In the treatment, two to six million cells are transplanted in and around the stroke-damaged areas of the brain.
The primary goal of this trial is to determine whether the therapy is safe and can be tolerated by patients.
"If this first study is safe, we hope to move on to a second study that will address patients with more diverse problems, using more cells and putting them in different areas," says Kondziolka. "It's difficult to say whether the functional gains some patients have described are due to what we've done or something else. Theres still a lot of research to be done and a lot of data to be collected before we can start this in a larger number of people."
The brain cells used for the treatment are provided by Layton Bioscience, Inc. LBS-neurons, as the laboratory-grown cells are called, originate from human tumor tissue composed of embryonic-like cells. In the laboratory, scientists have manipulated these cells to produce fully differentiated, non-dividing neurons. The tumor tissue is a teratocarcinoma, which occurs in the reproductive organs.
The surgeons use a computed tomography (CT) scan of the patient's brain to identify three or more sites to inject the lab-grown cells. In the patients, the injection points are located in the basal ganglia region of the brain, says Kondziolka.
Co-authors are Lawrence Wechsler, M.D.; Keith Thulborn; Carolyn Meltzer, M.D.; Stephen Goldstein; Peter Jannetta; Carol Slagel; and Elaine Elder, Sc.D.
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