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FROM: The Daily Record (Baltimore, MD) November 5, 2004 Friday HEADLINE: Proposed legislation in Md. to ban one type of stem-cell research causes concern BYLINE: Robyn Lamb A small Maryland biotech firm will soon release a report sure to fuel the big dreams of many Americans suffering from incurable diseases and conditions such as Parkinson's and paralysis. Using fetal-derived stem cells, Neuralstem Inc. recently helped paraplegic rats walk again. The Gaithersburg company intends to go public with results of its study in the next few weeks. "Once we publish, it will be clear that we're hitting something that is imminent for the future," said Richard Garr, Neuralstem's president and chief executive. "The debate [over stem-cell research] will be very different when it is not hypothetical." While Garr is obviously enthusiastic about the prospects of stem-cell research, he and others are increasingly pessimistic about the role Maryland -- one of the nation's top three biotech hotspots -- will play in the promising, yet highly controversial, field. The reason: Even as Californians were voting this week to create a giant $3 billion fund to finance such research, Maryland lawmakers were preparing legislation to ban an important type of it. "You'll see the entire country tilt toward California," warned Garr, who himself is considering moving his 8-year-old Montgomery County business to the West Coast. Considering how much Maryland is counting on biotechnology for its economic future, it's nearly impossible to exaggerate the impact such widespread defections would have, leaving many to wonder and worry: Will they stay or will they go? Clear as plasma Despite the prominence stem-cell research took on during the just-ended presidential campaign, there is still considerable confusion about what it is and what President George W. Bush's ban really encompasses. Stem cells represent the building blocks of the human body. They can both convert into other types of cells and tissue and replicate themselves. Some scientists believe they can use stem cells to regenerate tissue and organs damaged by diseases such as diabetes and Alzheimer's, to repair spinal-cord injuries, to create dopamine-producing cells that might cure Parkinson's, and even to grow new organs to replace those that are failing. There are two types of stem cells: adult and embryonic. Adult stem cells are harvested from a variety of sources, including umbilical cords, blood and bone marrow. Embryonic stem cells are of course harvested from embryos. Adult stem cells, many believe, do not have the same capacity for renewal as embryonic stem cells, are more limited in terms of uses, and are more difficult to grow in a dish. Scientifically speaking, embryonic stem cells seem to be superior. The controversy arises because harvesting cells from an embryo requires the destruction of that embryo, and many pro-life advocates view the destruction as murder. An opponent of abortion, President Bush limited public funding of stem-cell research to existing lines of embryonic stem cells. No other embryonic stem cells may be used in federally financed work. The prohibition spurred complaints from the scientific community that the president's permitted list is too short and includes many lines that are unusable. New arena Until recently, the fight over embryonic stem cells was taking place exclusively at the federal level. But now state legislatures are taking it upon themselves to regulate the technology, which is a blessing or a monstrosity, depending on whom you ask. More than 30 states have either passed or are considering stem-cell legislation. During the 2005 session of the Maryland General Assembly, which starts in two months, a group of legislators will submit a bill that would impose a total ban on the cloning of human embryos for any purpose. That may seem to have little to do with embryonic stem cells, but it does. Scientists can create embryonic stem cells through a process called nuclear transfer or therapeutic cloning. Scientists scoop all the genetic material out of an unfertilized human egg and replace it with genes from an adult cell. The egg, stimulated by a short electrical impulse, develops into the blastocyst -- the early form of an embryo. From that, stem cells can be removed. This type of stem cell is the genetic match of its donor, meaning it can be transplanted into the donor whose cells are damaged by disease. The process is just a step away from so-called reproductive cloning, a process most scientists do not condone. In reproductive cloning, the embryo -- instead of being interrupted in the blastocyst stage -- is implanted in a uterus to produce a human clone. Nevertheless, lawmakers want all types of cloning banned. Maryland's bill, modeled after the federal Brownback Bill that has passed the House, would make human cloning a crime punishable by up to 10 years in prison and up to $100,000 in fines. Violators could also face civil fines of $1 million or more. "There have always been " ethical problems that exist when independent labs and stuff come up with these new types of procedures," said the bill's sponsor in the House of Delegates, state Del. Curt Anderson, D-Baltimore. "You get into an area that might be ethically questionable. It [the bill] gives bright lines of what should and should not be done." Proponents of the bill argue a cloned embryo is a human even before implantation in the womb and to destroy it for research, or "as repair kits," would be immoral. "Asexual reproduction is wrong. It is abhorrent. It is immoral," said Nancy Fortier, an associate director of the Maryland Catholic Conference, a group created by the bishops of Maryland to advocate for the public-policy and pastoral interests of the archdiocese of Baltimore, Washington and Wilmington, Del. "The term therapeutic cloning is a wrong term. The definition of therapeutic is that it benefits the subject, but when you harvest embryonic stem cells, you kill the subject," Fortier said. "It's a misnomer." Fortier, who spearheaded the effort to introduce the cloning ban in the Maryland General Assembly, fears that allowing the research to go forward would result in poor women being encouraged to sell their eggs for research. "Where do you think you're going to get these millions and millions of eggs? You exploit poor women," she said. And for what, asks David Prentice, a cell biologist who plans to testify in favor of the Maryland ban. "The key word here is the 'potential' benefit to others," Prentice said. "There is little evidence that they are going to ever treat a patient." So far, every cloned animal has had genetic problems, Prentice said, adding that in lab research on animals, embryonic stem cells have been known to cause tumors and tissue rejection remains a huge hurdle. "I'm not saying that you could never get a treatment. If you pour enough time, money and effort into it you might. But in the meantime you're neglecting what is working: adult stem cells," he said. Viable alternative? It is true, doctors have been transplanting adult stem cells found in bone marrow to treat blood disorders and cancer for decades. For example, doctors can transplant bone marrow stem cells back into patients who have lost blood-forming tissue during radiation or high-dose chemotherapy. Doctors at the Cedars-Sinai Medical Center in Los Angeles recently treated a middle-aged Parkinson's patient with his own brain stem cells, which they extracted during a routine surgery. Doctors grew the stem cells in a dish, ultimately growing mature neurons, a certain number of which produced dopamine, a critical substance lacking in Parkinson's patients. Cardiac infarct, Chrohn's disease and various blood and skin diseases are among other illness treated. More recently, animal tests have shown that adult stem cells may have the ability to transform themselves into the cells of more organs than previously believed. In Baltimore, a team of researchers at the Johns Hopkins Kimmel Cancer Center this summer found stem cells taken from the bone marrow of mice developed into liver cells and helped restore liver function in mice with liver injuries. The technique -- if proved effective -- could eventually be used to treat chronic diseases like diabetes, cirrhosis of the liver, heart disease and cancer. Arguments against the potential of adult stem cells could hurt the research's development, some fear. "We don't know what our limitations are with adult cells, but we are doing more than we thought was possible. People who work on embryonic stem cells continue to say you can't use adult stem cells and that's probably not good for them either. A lot of those people are looking for funding so they say that adult stem cells don't work," said Mark Pittenger, vice president of research at Baltimore-based Osiris Therapeutics Inc., which is working to develop treatments with adult stem cells. After 12 years, Osiris is starting human trials using mesenchymal stem cells derived from bone marrow to treat the effects of chemotherapy and radiation as well as to improve heart function after heart attacks and heart disease. But neglecting embryonic research in favor of pushing adult stem cells is shortsighted and irresponsible, according to many research scientists. "The ethical issue to me is the slow rate at which we're moving to cure these diseases," said John Gearhart, a researcher at the Johns Hopkins School of Medicine and one of two scientists who first pioneered the isolation of human embryonic stem cells. "We have to step back and say, 'why are we doing this,'" said Chi Dang, vice dean of research at the Johns Hopkins School of Medicine. "We are doing this because, and I put this in quotations, 'the patient is waiting.' The patient is waiting for something new and in certain areas we have nothing to offer. Our moral obligation is to use science." Already a hub for stem-cell research, the university established the Institute for Cell Engineering in 2001 with an anonymous donation of $58.5 million. One of only a handful of such centers in the country, the institute's mission is to mold engineered human cells into therapeutic transplants for neurodegenerative diseases, spinal cord injuries, diabetes and heart failure. "In some diseases, Lou Gehrig's for example, we're talking windows of five to 10 years," Dang said. "We can't just say that adult stem cells are efficient. In five years, if we find out we're wrong, we're five years behind." Surely, the fledgling research on embryonic stem cells will take time. Neuralstem, for example, started out eight years ago trying to cultivate dopamine-producing cells for the treatment of Parkinson's. Initially the company could not get enough cells producing the chemical. By the time it did, Neuralstem did not have the resources or the funds to continue the line of study. "People still think stem cells are going to become an outlaw industry," Garr said. But perhaps equally important, he added, many people have the mistaken idea that the research follows straight and efficient lines. "The popular myth around stem cells is that if it works, it's a magic bullet and it works immediately. It's not a one shot, rifle shot deal and to say that we're not close just because it hasn't happened is wrong." On the outside? With the debate in full swing, U.S. states and foreign countries competing with Maryland for biotech companies are forging ahead, spending billions on embryonic research. Britain, for example, sped ahead to become the first nation to legalize human cloning for research. In the United States, California is now poised to take the lead. This has Maryland's biotech community fearing a loss of its competitive edge in the field. "Certainly if I was a company and I was locating, I would go to New Jersey or California," said Curt Civin, professor of oncology and pediatrics at Johns Hopkins University School of Medicine's Sidney Kimmel Comprehensive Cancer Center. Civin, who invented an antibody that is now the standard for isolating and collecting bone marrow stem cells used in cancer therapy, is working with embryonic stem cells these days to look at, among other things, how they might generate a good model for creating blood cells. Referring to a recent lecture he gave in Seoul, South Korea, Civin said, "I felt like I was tuning the picture on the television that I am going to be buying from them." "The world point of view of this is important. But from our own selfish point of view, there go the jobs and there goes the discovery," Civin said. Gearhart, who teaches at Johns Hopkins, said he is already seeing heavy recruiting of his students from California and beyond. In fact, two of his doctoral students have already made plans to move to Australia and Britain. For Civin it is the research itself at this point that will lead to treatments. "This doesn't have anything to do with transplanting the cells or creating limbs," he said. "The most important use of my own invention to purify adult stem cells has been the 10,000 papers published. The knowledge that has come from that has been far more important to science and patients than the small number of patients who have gotten treatment. And that is the way it will be with embryonic research." That's not necessarily true at Neuralstem. "For us, the main point is to get into humans and show we can cure a disease, " Garr said. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn