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Neuron transplants move ahead Procedure shown to be safe, but does it help stroke victims? Thursday, March 15, 2001 By Anita Srikameswaran, Post-Gazette Staff Writer
With the index finger and thumb of her right hand, Sylvia Elam made an OK symbol. Then her other fingers in succession tapped the tip of her thumb. Those fine movements, evident during her annual examination this week at the University of Pittsburgh Medical Center, had been lost following a stroke in December 1993.
Then on March 9, 1999, Dr. Douglas Kondziolka drilled a small hole into Elam's skull and injected 6 million lab-generated brain cells, or neurons, into the stroke-damaged left side of her brain. She was the last of 12 patients at UPMC Presbyterian to participate in the groundbreaking trial of human neuron transplantation for stroke.
The 12-patient trial showed the transplant was safe and could be taken a step further.
Next month, the first of another 18 stroke patients will get a neuron transplant. In this next phase of the research, higher numbers of the neurons will be injected and participants will have more tests so that doctors can measure the effect, if any, produced by the transplanted brain cells.
Elam and her husband believe that the experimental procedure was a tremendous success. Because of it, they said, she got up from her wheelchair and walked. Her sensation, taste and speech improved. Before suffering a second stroke in August 1999, she had tried and succeeded at driving a car.
During the checkup on Tuesday, Kondziolka asked Elam, 67, to squeeze his hand with hers. She showed him her dexterity with the finger and thumb touches.
"Wow, that's great," the doctor said.
Kondziolka told the couple about the upcoming study, which will also include participants from Stanford University.
"So I will probably get a few more [neurons]?" Sylvia Elam asked.
"I knew you were going to say that," the doctor answered. "That's what everybody wants to know." In the future, if neuron transplants become a proven treatment, she might receive more neurons. But for now, as a participant in the first trial, Sylvia Elam doesn't meet the criteria for the next phase of study.
"That's OK," Ira Elam said, chuckling. The transplant seemed to work, so "she just figures if she gets another 6 [million neurons], she'll just come out of it that much more."
Kondziolka recalled that he was surprised that at the time of the original operation, Sylvia Elam had said immediately that the numbness of her right side had lessened.
Researchers didn't expect any immediate response because they reasoned it would take time for neural communication networks to rebuild. But recent rat experiments have shown that the manufactured cells produce high levels of a neural chemical called a growth factor, which stimulates brain cells.
"If these [transplanted] cells have a chemical release right off the bat, that may be the reason why you would see an early effect," Kondziolka said.
He is still cautious about giving the transplanted neurons credit for improving stroke-caused impairments. The first trial wasn't designed to look for such effects, but to ensure the technique was safe.
Two of the first 12 neuron transplant recipients have died from causes unrelated to the procedure. Eight patients said they felt better. Six had improvements in their motor ability. Brain scans in six patients showed increased activity in the area of their strokes. There was no indication the transplanted neurons had caused harm.
Four patients, including Sylvia Elam, got 6 million neurons and the others got 2 million.
The neurons are manufactured by Layton BioScience Inc., based in Sunnyvale, Calif. A tumor provided the original cells, which have been chemically treated so that they are no longer cancerous and do not multiply.
In the upcoming study, patients will get either 5 million or 10 million neurons. If that dose causes no side effects, even more neurons might be given to participants in a subsequent study. Rat studies indicate that perhaps one-fifth of the cells live after they are transplanted, Kondziolka said.
All the 18 patients in the new trial will have eight weeks of physical therapy. However, four of them will not get a neuron transplant. Researchers want to know if the therapy can help patients recover function even years after the stroke occurred.
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