Infusions of Fetal Tissue Fail To Help Parkinson’s Disease

By ANTONIO REGALADO
Staff Reporter of THE WALL STREET JOURNAL

In a quiet disappointment for cell-based medicine, scientists have reported that a second large study of transplanted fetal cells has found no benefit for patients suffering from Parkinson’s disease. The treatments also caused serious side effects.

The results are a blow to hopes that infusions of brain tissue from aborted fetuses could reverse the degenerative brain condition, and may also damp expectations for treatments using stem cells.

Results of the study, which involved 34 patients, were presented at a scientific meeting last month by C. Warren Olanow, a neuroscientist at Mount Sinai School of Medicine in New York who led the research.

The patients received brain tissues from as many as eight fetuses, each approximately six to nine weeks old and the result of an abortion. Although brains scans showed that the transplanted cells appeared to be functioning normally, the researchers reportedly weren’t able to find any measurable improvement on tests of motor and other skills.

But the most severe setback was side effects such as uncontrolled motions of the limbs, which affected 13 of the 23 patients who received cells. Three of them had symptoms so severe they required an additional surgery to control them, according to people who were present at Dr. Olanow’s presentation.

Dr. Olanow and other doctors involved in the study, including neurosurgeon Thomas Freeman of the University of South Florida, didn’t return calls seeking comment. Through an assistant, Dr. Freeman said that he wouldn’t comment on the study before it was published in a medical journal, which he indicated would occur early next year. However, the study’s results are being widely discussed by specialists in the field.

The test was the second of two government-funded efforts to study whether cells from aborted fetuses can repair the brains of Parkinson’s patients. An earlier study, led by Curt Freed of the University of Colorado, also led to cases of severe dyskinesia, or involuntary movements, although some patients also seemed to improve.

Because that study was deemed inconclusive, scientists had been eagerly anticipating the latest results. Dr. Freed, who learned of the outcome at the 7th International Congress of Disease and Movement Disorders, last month in Miami Beach, Fla., said he was “personally disappointed and surprised by the outcome.”

Parkinson’s disease afflicts at least 500,000 in the U.S. and millions more world-wide. Its symptoms, including loss of balance, tremors and slurred speech, are caused in part by the death of cells that make dopamine, an important chemical in the brain. Scientists have hoped that providing new cells capable of making dopamine could treat the symptoms, and prevent the disease from worsening.

The new results could mean a winding down for fetal-cell transplants, an idea that was once intensely controversial but which has since been upstaged both politically and scientifically by research on stem cells taken from embryos. Stem cells are considered more versatile than fetal cells, and can be grown and carefully characterized in the lab.

However, the negative results of Dr. Olanow’s study are also putting question marks over heavy investments in stem-cell research by several companies and nonprofit foundations. “This has profound implications for the ability of stem cells to treat Parkinson’s disease,” said J. William Langston, scientific director of the Parkinson’s Institute in Sunnyvale, Calif. “Why isn’t it more efficacious? There are a lot of theories, but we don’t know.”

Several biotechnology companies developing cell-based treatments, including Geron Corp. of Menlo Park, Calif., and Stem Cells Inc. of Palo Alto, Calif., have indicated that Parkinson’s is a key development target. Even stronger support has come from the Michael J. Fox Foundation for Parkinson’s Research, which since 2000 has financed about $6 million in research on turning stem cells into dopamine-making neurons.

“This is a surprising result that forces reconsideration of transplantation without a great deal more research,” said Anthony Lang, a Parkinson’s expert at Toronto Western Hospital in Canada. The National Institutes of Health, in Bethesda, Md., which spent $14 million to support the two studies, isn’t planning to fund further clinical trials in the near term.

Although the Bush administration has curtailed research on cells taken from embryos, work on fetal tissue is covered by a separate rule put in place in 1993 by President Clinton. Congress subsequently passed legislation to ensure women aren’t paid or induced to have abortions to provide tissue, which is voluntarily donated. Antiabortion groups remain fiercely opposed.