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Cloning Advocate Fights the Clock on Capitol Hill

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TIMES STAFF WRITER

As a young evangelical Christian, Michael D. West would protest outside abortion clinics, urging women to consider the value of life growing within them. Today, he will tell a Senate panel why he is now a leading advocate for a far different proposition: cloning humans as a way to cure disease, even if it means destroying human embryos.

West is chief executive of Advanced Cell Technology Inc., the Massachusetts company that touched off a worldwide debate last week by announcing that it had created the first human embryos through cloning. President Bush called the work “morally wrong” for creating life only to destroy it. The Vatican offered “unequivocal condemnation.”

On Monday, Senate Republicans unsuccessfully tried to force a vote on a six-month moratorium on human cloning, with jail terms for violators. The House passed a permanent ban in July, and Senate leaders have promised to debate the issue next year.

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Now, West has become a man with an additional mission: to persuade Congress, before it outlaws much of his work, that cloning might one day help doctors replace the failing tissues that cause diseases.

“We are certainly at risk,” West said recently at his home in suburban Boston, “but only because people don’t understand the benefits of this to humanity. Can we educate them quickly enough?”

It is a moment of high drama in science and lawmaking, and Congress has been focused on whether cloning, even as a medical tool, is an unethical use of human life. But even as it conducts its controversial cloning work, Advanced Cell Technology has been carrying out a parallel set of experiments designed to show that cloning can be used for the most pressing of purposes: to help ailing patients.

These ongoing studies, which have not been published in a scientific journal, offer evidence that cloning indeed holds promise in curing a range of diseases, company researchers say. They were done using cows, and the company calls them the best animal model yet for how cloning might one day be used to help people.

While the human cloning work set off an ethical firestorm, the company has published much of its previous research in top scientific journals, and it is considered by experts to be a leader in the cloning field.

Cloned Kidneys Proved Functional

In the new studies, researchers cloned a cow to produce heart and skeletal muscle, and other tissues that were transplanted with better success than transplanting non-cloned tissue. The company and a collaborator, Anthony Atala of Children’s Hospital Boston, say they even created miniature kidneys from cloned cells that functioned when transplanted to a cow.

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“This was proof of the principle that therapeutic cloning can be done,” Atala said. Starting with just a skin cell from the cow, which is used to initiate the cloning process, “you can somehow create other tissues that can be transplanted with no tissue rejection.” In addition, Advanced Cell Technology is trying to use cloned cells to reinvigorate a cow’s entire immune system. The experiments were conceived and managed by Dr. Robert Lanza, a company official. The company had not previously discussed them in detail.

The work has not been published in a scientific journal, which entails review of the data by independent experts and generally is required before results are considered credible. Yet, the company says, the preliminary results help build the case that the vision for cloning as a medical tool is a realistic one.

Some day, West said, a patient could be cloned to produce an embryo, which would be harvested at about five days for its stem cells. In theory, the stem cells could be grown into any cell type or tissue the patient needs--insulin producing cells for a diabetic, heart cells for a cardiac patient, brain cells for someone with Alzheimer’s disease.

Because the cloned tissue would contain the patient’s genes, it might be less likely to be rejected by the patient’s body. The body rejects foreign material, and so under current practice, patients receiving transplants must take high doses of immuno-suppressive drugs--and even then, not all transplants succeed.

There are many scientific uncertainties, however. It is unclear that people truly can be cloned. The company has produced several human embryos through cloning, but the most successful grew only for about three days, not long enough to produce stem cells. It will be years before scientists can reliably turn stem cells into transplantable tissue--if they can do it at all.

And now, there are rising political challenges to West and his company.

Many people find the idea of cloning-based medical treatments to be repugnant because they would require the creation and destruction of human embryos. That is unacceptable to anti-abortion groups, the Roman Catholic Church and others, who are lobbying Congress to bar cloning for any purpose.

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Moreover, an embryo created through cloning, even if made only for its stem cells, theoretically could be transferred to a surrogate mother and grown to term. Some people say that if cloning for stem cells is allowed, then cloning to produce children is sure to follow. Advanced Cell Technology opposes human cloning for reproductive purposes.

Still, West says cloning may prove to be a crucial medical technique.

West’s Life Took a Detour

“Millions and millions of lives are at stake here,” he said. “If I were a U.S. congressman, I wouldn’t want to be wrong on this one. . . . I wouldn’t want someone to say, ‘We’ve tallied that 15 million children died of diabetes because of that vote you took.’ Ouch!”

Headstrong but soft-spoken, West says he grew up a science junkie in Michigan, a kid who wore electrodes at night and studied the printout of his brain-wave patterns between English class and gym. At the same time, he gravitated toward evangelical Christianity, even though he was raised with no religious affiliation.

Bringing a scientific intensity to religion, West studied Greek and Hebrew to understand ancient texts. While pursuing a master’s degree in biology, he set out to show that fossils contained proof that a divine being created the universe.

Instead, he was “pulled kicking and screaming” to a different conclusion.

“Look at these,” West said recently, pulling several small stones from the display case in his den. “You go into the fossil record, and you see that these evolutionists weren’t making everything up.”

He held up a fossil of a fern, 330 million years old. Its imprint in the stone, he said, was too perfect and undisturbed to have been made during the flood described in the Bible.

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West later devoted himself to investigating the molecular mechanisms of aging and founded Geron Corp. of Menlo Park, Calif., to look for longevity genes. While there, he funded the university scientist who first isolated and cultured human embryonic stem cells, considered one of the major scientific breakthroughs of the last decade.

Now, West believes, an embryo in its first two weeks is “cellular life, not human life.” The cells of a young embryo are like “lumber stacked up” waiting to build a person. “But they are not yet a person.”

In its ongoing and unpublished studies with cows, Advanced Cell Technology says it has used cloning to:

* Produce thriving heart and skeletal muscle.

The company cloned a cow and grew the cloned embryo for 39 days. It then took heart and skeletal muscle cells from the embryo, destroying the embryo in the process.

The tissue was transplanted into the cow the skin cells were taken from. At the same time, researchers transplanted non-cloned tissue into the cow.

Three months later, tests showed that the cloned tissues had been incorporated into the cow and were producing the signature proteins of healthy heart and muscle cells. By contrast, the non-cloned tissues gave off “none or very little” protein, Lanza said.

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* Create functioning miniature kidneys.

Using cells from a cloned cow embryo, ACT molded a small and primitive kidney, about an inch long and composed of as many as 10 cell types.

When placed in a cow, Lanza said, the tiny kidneys filtered waste products from the bloodstream, much as a normal kidney would. “This is the first time therapeutic cloning has been used to create any sort of functional organ, primitive though it may be,” he said.

* Attempt to boost the immune system.

The company cloned two cows, grew the embryos for 100 days, and then took cells from the embryos that give rise to the immune system.

The cells were injected back into the cows that had been cloned.

The results still are uncertain. “Basically, we’re looking now for these cells to replace the immune system with younger and more vibrant cells,” Lanza said. “We want to show that you can take an aged animal--a complex animal with a complex immune system--and give it an all-new immune system.”

These three experiments differed in a crucial way from how cloning might work with human patients.

As generally envisioned, doctors would grow a human embryo for five or six days--only long enough to obtain embryonic stem cells, which then would be grown into specialized tissues.

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But no one has been able to prompt cow stem cells to turn into these various specialized tissues. That is why the researchers had to allow the cow embryo to grow for several weeks, to a point where the cells had matured into early-stage heart, muscle and other tissues.

All three experiments were designed by Lanza, a former whiz kid whose high-school tinkerings with chicken genes eventually were published in the prestigious science journal Nature.

At UCLA in the 1980s, Lanza noticed that self-donated cells worked best in transplantation. When doctors removed a diseased pancreas, they would return insulin producing cells to the patient in hopes of preventing diabetes. Often, this worked. But when doctors transplanted insulin producing cells from cadavers into patients, the surgery often failed.

Now, through cloning, Lanza hopes to help patients use their own cells to treat diseases.

While preliminary, the company’s research might play a role in the public debate about cloning.

This summer, groups representing people with juvenile diabetes, Parkinson’s disease and other ailments were key in persuading lawmakers to support federal funding for stem cell research, a controversial matter in its own right. But some of those same groups say they do not plan to lobby aggressively in favor of cloning as a medical tool because its promise has not yet been proved.

“There needs to be proof that this technology could indeed provide a therapy,” said Peter Van Etten, president of the Juvenile Diabetes Research Foundation International. If there were proof, “then you might well see stronger support” for cloning among patient groups.

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Van Etten said he was intrigued by the Advanced Cell Technology work in cows. But he said the company should have published those results before making its announcement last week that it had created four- and six-cell human embryos through cloning, work that was led by company scientist Jose Cibelli.

“I think that hurt the cause” of cloning, Van Etten said, “because it pumped the issue up to a fanfare but didn’t prove there would be any benefits to patients.”

But to West, the need for new medical treatments is so pressing that it must move quickly, he said.

“You can’t do this in a linear way. If you want to go to the moon in 10 years, you can’t just work on the guidance system and say, ‘If that works, then we’ll go do the second-stage booster.’

“The world is falling apart for that person with diabetes. If you don’t understand that, then you haven’t had someone die of disease, or you don’t care.”

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