Stem cells raise hopes, but is there money in them?

Madison, Wis. — One of the more hopeful promises of stem cells is the creation of new organs, grown to meet the medical demand that is not being met by organ donation. But experts expressed concerns at last week's Stem Cell Symposium that high hopes could lead to backlash: among patients if cures do not materialize, and among investors if nobody can make money on them.

Cell transplants are just one way that stem cells could be used in the medical and pharmaceutical industries, but it is perhaps the most attention-getting. Just over 6,000 people in the U.S. each year become organ donors - meanwhile, nearly 4,000 people per month go on waiting lists.

The demand is there. But as Alan Coleman, CEO of Singapore-based ES Cell International, pointed out at the symposium, "Nobody's made money off bone marrow transplantation in 40 years." Bone marrow came up because it's a cell transplantation therapy already in use outside the research lab - in fact, it is a stem cell therapy.

Bone marrow contains adult stem cells, the cells inside the grown body that regenerate certain organs and tissues over time. Much of the headline-grabbing work in Wisconsin and elsewhere is on embryonic stem cells, which can grow into any cell in the body if properly prepared.

Uses around the lab The problem with transplants is that your body rejects most of the cells, meaning production has to be high. The idea has been floated that individualized cell cultures could be created based on the DNA of the person who needs treatment, but Coleman doesn't see that solution working except for billionaires.

Not all potential uses of stem cells involve patients directly. Clive Svendsen, a neurology professor with the University of Wisconsin-Madison's Waisman Center, said a more accessible use for the cells is drug screening and modeling, in which stem cells are used in the lab to create samples of tissue with known DNA to test drugs or other compounds

That could be the first source of money for a commercial stem-cell industry, well before transplant therapies even pass through clinical trials. But it's too early to say whether that will be enough to sate a public that has been told stem cells will lead to cures.

"I hate to say `cure,' because once you say `cure' the expectations are set very high," Svendsen said at the opening of the symposium. He said later that it may simply be too early for industry to move into the stem cell field. As a researcher, he doesn't have a problem with that. There is still plenty of basic science to be done on stem cells before we understand exactly how they work and how to make them work for us.

Patentable or not, here we come

The Wisconsin Alumni Research Foundation, parent organization of stem-cell research group WiCell, has created a stir in the United States by asserting its rights to patents on some of the fundamentals of human embryonic stem cell research. In Europe, the situation is a little different.

Timothy Caulfield, research director at the Health Law Institute in Alberta, explained at the Bioethics Forum in Madison, also last week, that the European Union has already declined WARF's patents on the basis of a subjective principle of the immorality of patenting life, codified in Europe's ordre publique.

Some European countries, including Sweden, have individually granted the patents. The United Kingdom patent office granted them in a decision that explicitly acknowledged moral concerns but said the benefits of commercialization and potential therapies outweighed those concerns. In Canada the patents are pending.

Caulfield said the "commercialization of life" is a persistent public worry, though there is no accepted definition of what the phrase means. Coleman said patent issues were on some people's minds as much as the controversy over the origins of stem cells and the sanctity of life, though.

"If you saw the popular press out west, you'd think that no one except WiCell is going to make money from the exploitation of human embryonic stem cells," he said.