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Brain-cell transplants helping stroke victims in Pitt study
Friday, February 05, 1999 By Anita Srikameswaran, Post-Gazette Staff Writer
For seven months, stroke patients and researchers have been waiting and wondering about the outcome of the world's first brain cell transplant to repair stroke damage.
The news is good.
Three of the nine patients who have had the procedure, performed at the University of Pittsburgh Medical Center, have told their doctors that their symptoms, such as difficulty with walking and weakness of limbs, have improved.
While the researchers said those improvements could not be substantiated through objective tests such as physical exams or brain scans, they are pleased that the procedure has not caused any ill effects, and they hope to begin the next phase of clinical trials before the end of the year.
The Pittsburgh researchers have been deluged with letters and calls from stroke victims volunteering for the experimental procedure and offers from other universities that want to be sites for future trials.
"The good news here is we haven't burst a bubble by having bad safety data," said neurosurgeon Dr. Douglas Kondziolka, one of the study's principal investigators. "So far, everything has gone well."
Co-investigator Dr. Lawrence Wechsler, director of UPMC's Stroke Institute, yesterday presented interim findings on the study at the American Heart Association's International Conference on Stroke and Cerebral Circulation in Nashville, Tenn.
An estimated 3.8 million U.S. stroke victims are alive today and about half a million Americans suffer new or recurrent strokes each year. It is the leading cause of serious, long-term disability.
Wechsler presented information about seven male and two female recipients, all of whom were between 50 and 75 years old. The first transplant was performed July 2, 1998, on Alma Cerasini, now 64, a former health-care worker from Pittsburgh. The participants have come from around the country as well as from the Pittsburgh area, Wechsler said.
One woman said she walked better and her speech had improved. One man said he could move his fingers and toes a little more and another felt his muscle motion was more fluid.
Wechsler said the researchers periodically evaluated the patients' status using a variety of "stroke scales," but had not been able to measure any significant change. On some tests, for instance, the patient's score may vary simply because the patient's energy level changes or because he tries harder. Magnetic resonance imaging and positron emission tomography scans done so far have detected no change in the stroke region.
The researchers emphasized that this first trial is conducted to ensure safety, not to look for effectiveness. By the conclusion of the study, they will have treated 12 people, all of whom had severe difficulties with motion and strength due to strokes in an area deep in the brain called the basal ganglia. The last transplants will be performed within the next month.
The brain cells, called neurons, were made in a lab by Layton BioScience, Inc., of Atherton, Calif. Immature cells, isolated from a rare cancer, are manipulated into neurons, which are then purified, multiplied and frozen for delivery to the research center.
About 2 million neurons are injected into the dead brain tissue left by the stroke, using a needle inserted through a small hole drilled into the skull. For two months afterward, the patients take anti-rejection drugs such as cyclosporine.
All the participants were able to go home the day after the transplant. One patient had a seizure six months later, but that is expected with some strokes. Anti-seizure drugs have prevented the problem, Wechsler said.
Several patients complained of fatigue, he added, which appeared to be related to the cyclosporine. That cleared up once the drug regimen was complete.
If the remaining patients in the trial do not have problems, the next phase will get under way. More cells could be injected into a different place near the stroke.
In that phase, there will be tougher questions to answer. How much improvement is necessary for the transplant to be worthwhile? A simple wiggle of once-paralyzed fingers, or the return of writing skills?
"I don't know how much improvement would be needed to make this generally available," Kondziolka acknowledged.
That's why the Food and Drug Administration is watching the trial closely. Many stroke patients would take any chance to recover the function in a weakened limb, or to speak clearly again.
"We have received over 2,000 requests from people who want to be a part of this study," Kondziolka said. "We received letters from people who didn't even have a stroke. You know, 'Can you put brain cells into me, please?' "
Such requests have come from people who have seizure disorders, head trauma and neurological problems from childhood.
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