A Clearwater company uses the debate over embryonic stem cell research to promote its business as an ethical alternative. But is it?

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A Clearwater company uses the debate over embryonic stem cell research to promote its business as an ethical alternative. But is it?
By WES ALLISON

© St. Petersburg Times, published July 30, 2001


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A Clearwater company uses the debate over embryonic stem cell research to promote its business as an ethical alternative. But is it?
U.S. Rep. Chris Smith equated research on embryonic stem cells with treating humans as guinea pigs as he advocated his bill to finance research into other types of stem cells, including those from the umbilical cords of newborns.

With the New Jersey Republican at that Capitol Hill news conference last month was Dan Richard, founder and CEO of Cryo-Cell International, a Clearwater company that collects and stores umbilical cord blood. He explained how stem cells from cord blood were being programmed to replace damaged brain cells, which could lead to treatments for stroke, Parkinson's, even autism.

"That's why we're so enthusiastic, so breathtakingly enthusiastic, about this alternative," Smith told the cameras after Richard's speech. "Every day, practically, there's some new breakthrough."

As politicians argue the future of federal funding for embryonic stem cell research, Cryo-Cell is using the debate to boost the profile of its business and presenting umbilical cord blood as an ethical, alternative source of stem cells.

"Our position has been that we believe negating a life to save a life, when you have an alternative, is not necessary," said Gerald Maass, Cryo-Cell's executive vice president.

But some researchers say Cryo-Cell's pitch doesn't give the full picture. It's not yet clear whether stem cells from cord blood truly are a viable or equally promising alternative to human embryos.

Several experiments in mice, including some partly funded by Cryo-Cell at the University of South Florida, show cord blood cells may replace damaged brain cells, but that research is still young.

Dr. Barron Lerner, an internist and medical ethicist at the Center for the Study of Society and Medicine at Columbia University, said Cryo-Cell's approach makes for good business but uncomfortable science.

"This sort of encroachment of business practices into research ethics, they're sort of pushing the envelope on that," said Lerner, author of a new book on money and research called The Breast Cancer Wars.

"But (they're) doing so very openly. You read their stuff, and they're out there (saying), 'We think this is more ethical, here's why we think this is important,' " he said. "But I think the average consumer would sense that things are further along than they really are."

The company says it doesn't oversell the technology, and has not formally opposed embryonic stem cell research, but it has aligned itself with politicians and organizations that have, including the Vatican. If federal funding for research on embryos stops, millions of taxpayer dollars likely will go for research into alternative sources, including bone marrow, other organs and cord blood.

Cryo-Cell officials say the company wouldn't benefit directly, since it doesn't do much research and doesn't sell cord blood for research. Its business is to save the umbilical cord blood of newborns at their parents' request and preserve it for possible future use -- such as treating blood diseases the child might later develop.

But the company would benefit indirectly: Public awareness about cord blood banking would improve, possibly leading more parents to use the service. And more federally supported research would be expected to discover more uses for cord blood, providing Cryo-Cell with new selling points, President Wanda Dearth said.

"Certainly, there must be a positive effect because they're going to need an alternative, and people may finally sit up and and take notice that the Cryo-Cells of the world are here," Dearth said. "They're going to say, 'Where do we go?' "

Blank slates
Stem cells often are described as blank slates, or master cells, theoretically capable of becoming any cell in the body. Researchers think they eventually will be used to replace damaged or dead cells, providing a cure for everything from Parkinson's to spinal cord injuries to heart disease.

The best place to find these cells is still being investigated. Cord blood is loaded with stem cells. Stem cells also are found in bone marrow and organs, including the brain.

But for now, embryonic stem cells seem most promising, because they appear to be true blank slates. They are harvested before they've been given any roles to play, and experts say they have proven highly maleable.

The National Institutes of Health funds the bulk of basic research at universities and medical centers across the nation. President Bill Clinton allowed that money to be used for research of embryonic stem cells, and President Bush is considering whether to allow it to continue.

Most of the embryos used for this purpose were conceived in fertility clinics. They are leftovers and ordinarily would be discarded. But critics say using them for research is unethical, because it destroys a potential life.

Rep. Smith's bill, called the Responsible Stem Cell Research Act of 2001, would earmark $30-million for research into sources other than embryos. The congressman, one of the most ardent opponents of embryonic stem cell research in the House, invited Cryo-Cell to participate after the company sent open letters to Bush and Congress asking support for a campaign to persuade parents to bank their children's cord blood.

Some stem cell experts questioned the company's role.

"Certainly, that appearance several weeks ago (with Smith) was one that I found quite inappropriate from a biological sense," said Dr. John Gearhart, a stem cell pioneer and professor of obstetrics and gynecology at Johns Hopkins University.

"But from a business sense, you can see why. They want people to invest in that, and to use their services. And let me tell you, I have many, many couples, being an ob/gyn, who want to know if they should save cord blood.

"You say, 'Look, for (blood) things it's okay, but don't count on anything beyond this.' "

Promising research
Cryo-Cell is a publicly traded company (Nasdaq: CCEL) founded in 1992. It charges $275 to collect a newborn's umbilical cord, then stores the white cells, including the stem cells, for $50 a year. The blood cells of nearly 20,000 children are kept in liquid nitrogen, at -196 degrees Celsius, at the company's headquarters on McMullen-Booth Road.

Cord blood stem cells have been used successfully for years for bone-marrow transplants to treat leukemia and other blood diseases and recently were used to treat a patient with sickle-cell anemia. Storing a newborn's blood ensures a perfect match should he or she ever need such a transplant.

But how these stem cells will behave when they're reprogrammed in a lab and transplanted into a brain or liver or pancreas remains to be seen. The stem cells in cord blood already have been assigned as blood cells, which might limit their ability to become other cells.

Scientists at Johns Hopkins now are comparing the abilities of embryonic stem cells to stem cells from other sources. None seems to work as well so far, although they have not yet tested cord blood cells. "But I have not seen any data that would say that these cells have the plasticity of embryonic stem cells," Gearhart said. "No way at all."

Recently, his team chemically manipulated embryonic stem cells into neural cells, then inserted them into the spinal columns of mice whoses hind legs were paralyzed. The mice are walking, albeit awkwardly.

But cord blood backers have their own mouse story. In February, teams from USF in Tampa and Henry Ford Hospital in Detroit reported they had reprogrammed cord blood stem cells into neural cells, then implanted them in mice that had suffered strokes.

Tests showed most of the treated mice regained much of their cognitive ability.

Experiments in humans are likely a couple of years away, and there is still a lot that scientists don't understand, said Dr. Paul Sanberg, a neuroscientist and director of the Center for Aging and Brain Repair at USF.

"Clearly, it's still in the promise stage, just like embryonic stem cells are still in the promise stage."

Cryo-Cell has given $200,000 and 65,000 shares of common stock to CCEL Biotherapies Inc., a partnership between Cryo-Cell and Sanberg, to support research into cord blood stem cells. The company gives donated cord blood to USF and other institutions for research.

Asked about Cryo-Cell's involvement in the stem cell debate, Sanberg said, "Cryo-Cell is clearly in the cord blood business. They're interested in stem cells, and they're interested in looking at and focusing on that source of material as a source for stem cells that could be very potent.

"We don't know the best avenue yet, perhaps, but this is clearly an avenue that shows a lot of promise, from both an ethical and a scientific point of view."

Cord blood may have some advantages: With 4-million births a year, it's widely available and is non-controversial. These cells also seem less likely than others to be attacked by the body's immune system if they're implanted.

Dr. Dennis A. Steindler, professor of neuroscience and neurosurgery at the McKnight Brain Institute at the University of Florida in Gainesville, said cord blood cells also seem fairly maleable. Researchers there are working with them, as well as with stem cells from brains, muscle, the liver and other organs.

"The data unfortunately, still leaves some gaps," Steindler said. "We are probably going to learn how to manipulate cord blood stem cells, and bone marrow stem cells, into becoming the types of therapies we want them to be. But we're not quite there yet."

Last month, Cryo-Cell Europe signed a contract with a Vatican-owned hospital in Milan to open a cord blood bank there. Last week, when Pope John Paul II met with President Bush, he decried the use of embryonic stem cells, but said cord blood research should be encouraged.

Cord Blood Registry, a Cryo-Cell competitor based in California, also is promoting the potential use of cord blood stem cells as master cells. The company asked Sen. Sam Brownback, R-Kan., who opposes embryonic stem cell research, for more funding for cord blood research.

On the other side, an organization that represents biotechnology companies looking for practical uses for stem cells is lobbying for continuing embryonic funding. So are the nation's major medical, scientific and disease advocacy groups.

Bush is expected to announce his decision regarding funding for embryonic stem cell research next month. In the meantime, Dearth said Cryo-Cell expects the debate to continue generating calls from expectant parents interested in hearing what stem cells are about.

"As long as people are talking about stem cells, that's positive for us," Dearth said. "The difference between today and six months ago are dramatic. Not to mention a year ago, or two years ago."


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