DENVER — The results of the latest and most extensive study of aborted fetal tissue transplants into Parkinson's patients have shown the therapy to be a failure.

Curt Freed of the University of Colorado Health Sciences Center in Denver recorded no measurable benefit among Parkinson's sufferers over the age of 60 who had aborted fetal brain tissue directly injected into their own brains. The tiny positive effects measured among patients younger than 50 were offset by the devastating, disabling and apparently irreversible side effects they experienced following the procedure.

Fifteen percent of the patients who received fetal brain transplants in the $5.7 million study, financed by the National Institute of Neurological Disorder and Stroke, have experienced runaway dyskinesia — uncontrollable muscle spasms causing them to twitch, writhe and fling their limbs spasmodically.

“They chew constantly, their fingers go up and down, their wrists flex and dis-tend,” Paul Greene, a neurologist at the Columbia University College of Physicians and Surgeons and a named author of the study in the March 8 issue of the New England Journal of Medicine, told the New York Times. “It was tragic, catastrophic.”

One patient's side effects were so bad, Greene added, he had to have a feeding tube inserted and lost his ability to speak. Such effects do occur in other Parkinson's patients, but they can be relieved by lowering medication doses. But with the fetal tissue recipients, reducing medication failed to alleviate the symptoms.

“No more fetal transplants,” said Greene. “We are absolutely and adamantly convinced that this should be considered for research only. And whether it should be research in people is an open question.”

Fetal tissue transplants were once the brightest hope for many people affected by Parkinson's disease, which occurs when the substantia nigra region of the brain fails to produce the brain chemical dopamine, causing patients to experience loss of muscle control, tremors and crippling “frozen” spells. It was hoped that implanted fetal brain cells would integrate into the host brain and take over dopamine production.

Since 1985 more than 360 Parkinson's patients have undertaken the surgical transplant procedure in at least 17 centers transplant procedure in at least 17 centers worldwide, but the small poorly designed studies of the results were inconclusive. Freed's study, conducted with Stanley Fahn of Columbia University College of Physicians and Surgeons, was the first to use a “control” group to eliminate the “placebo” effect that occurs in many medical treatments, in which patients report positive results that can not be objectively attributed to the treatment itself.

The researchers took 40 Parkinson's patients and divided them into two groups: half had a real transplant surgery; half had a sham surgery — holes were drilled into their heads but no tissue was implanted.

40 Aborted Babies per Patient

Each patient in the transplant group received four injections — the midbrain of four 7- to 8-week-old aborted babies. Freed told a Register correspondent last year that only one in 10 aborted fetuses renders useful tissue. So each Parkinson's patient required 40 aborted babies' brains.

Between 700,000 and 1 million Americans suffer from Parkinson's disease. If the study had shown great promise, there would have been a staggering demand for aborted tissue.

The tragic side effects have not been limited to Freed and Fahn's study, however. Thomas Freeman of the University of South Florida, who is completing a similar federally funded control trial of 34 patients due to be published this summer, said 2 of 7 transplant recipients from another study he conducted in 1993 have had similar problems.

One patient has uncontrolled muscle movements “all the time,” said Freeman. He is considering doing a pallidotomy (surgery to destroy brain tissue) to try to halt the uncontrolled movements. The other patient's dyskinesia is limited to his foot.

“If you looked at all the smaller numbers of patient studies, we each have found one or two of these [negatively affected] patients,” said Freeman.

“Fifteen percent of patients with disabling side effects, in all fairness, is heartbreaking for those individuals, but it is not that bad for a brand new experimental procedure,” said Freeman.

Tissue Caused Tumors

Those 15% are fortunate, according to Freeman, considering that two patients have died as a consequence of fetal implants. One case, described in the Register last year, was outlined in 1996 in the journal Neurology. A 52-year-old American man with Parkinson's paid a California doctor to fly to China to surgically implant aborted human tissue into his brain. Just weeks after the surgery both the man and his wife were convinced his health was much improved.

Twenty-three months later he died suddenly, however, and an autopsy revealed that the fetal tissue had indeed begun to grow — but not as nerves but as tumors that, doctors speculated, compressed his brainstem and led to his death. Some tissue from the aborted baby had grown wildly into hair, skin and bone within his brain.

Yet Parkinson's patients continue to be enthusiastic about fetal tissue transplants. Three of Freed's patients in the University of Colorado study, including two who suffered serious side effects, told The Times of London last week they would go through the procedure again, despite the disappointment. One patient had had a device implanted in his chest to control spasmodic uncontrolled arm flinging.

Freed's own enthusiasm for fetal transplant therapy has not waned. In e-mail correspondence, he told the Register, “Everything about our study is compatible with fetal cell transplant as a promising treatment for [Parkinson's disease]. Results have already led us to modify the transplant in ways that we expect will improve outcome and reduce risk.” He intends to continue to perform fetal tissue transplants at a cost of $40,000 each.

The University of South Florida's Freeman also thinks that calling off fetal tissue transplants would be “short sighted,” because new transplant techniques are developing. “There are really a lot of ways to skin a cat,” he said. “It took 30 years to do the first successful kidney transplant, but every year there was a 2% improvement in survival.”

A growing cadre of medical experts is criticizing the therapy, however. William Landau, professor of neurology at Washington University in St. Louis called it “incredibly naive” to compare a transplant into the complex human brain to a “simple pumping organ like the heart or kidney.”

Landau has vigorously opposed fetal transplants for more than a decade, not because of the ethics of using aborted baby tissue, but because of the experimentation on humans before adequately testing the procedure in monkeys. He said he would tell patients asking for fetal transplants: “If you want to go out and have your brain mutilated by an —— and pay a lot of money for it, go ahead.”

“To say Curt Freed is not well thought of within the medical community is an understatement,” added University of Toronto neurologist Paul Ranalli, who has in the past called fetal tissue transplants “yet another attempt by abortion advocates to fashion an altruistic spin on modern medicine's most shameful ongoing practice.”

Stem Cell Experiments

But fetal tissue transplant's light is fading under a new rising medical star. “Everybody is gearing up towards stem cells now,” said Freeman, referring to the cells derived from the inner mass sucked out of developing human embryos. “If history is going to judge this era, fetal tissue provided a road map to other advances. …We are in the process of learning lessons.”

Landau is still skeptical. “Now the popular issue is stem cells and I'm very fearful there will be a rush to pump stem cells into human brains and spinal cords without adequate experiments in animals first.” Already, researchers have begun to “dump stem cells into damaged brains of stroke patients,” Landau said, a practice he sees as virtually indistinguishable from fetal tissue transplants.

Said Landau, “It's criminal malpractice in my judgment.”

***Vatican logo here

In his 1995 encyclical Evangelium Vitae (The Gospel of Life), Pope John Paul condemned as morally illicit all medical procedures “that exploit living human embryos and fetuses-sometimes specifically “produced” for this purpose by in vitro fertilization - either to be used as ‘biological material’ or as providers of organs or tissue for transplants in the treatment of certain diseases. The killing of innocent human creatures, even if carried out to help others, constitutes an absolutely unacceptable act” (No. 63).

Celeste McGovern writes from Portland, Oregon.