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Last summer, President Bush made "stem cells" a household term. Now, Cleveland researchers and activists wrestle with what public funding and new awareness mean for the city's medical and biotech communities.
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by Christopher Johnston na spacious biomedical research laboratory at University Hospitals of Cleveland's Ireland Cancer Center, Stanton Gerson, M.D., directs more than a dozen physicians and scientists. Each day, they marshal the tools of their trade to test the elastic capacity of stem cells the body's primitive building blocks for developing a variety of organ tissues. After drawing samples from a tissue-culture incubator, one researcher peers into a confocal microscope to track intracellular proteins; another employs customized laser equipment to scan the surface of individual cells for special biological markers. Through a series of sophisticated procedures, Gerson's lab can find stem cells, determine what sort of tissue they match, separate and grow them,
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Gerson oversees cell and gene therapy research at University Hospitals and the Case Western Reserve University School of Medicine. His research focuses on stem cells derived from bone marrow for transplants - hematopoietic stem cells, which become blood and bone marrow cells, and mesenchymal stem cells, which become bone, cartilage, tendon, muscle and other connective tissues in the body. Though microscopic in size, stem cells are the centerpiece of research that many anticipate will lead to revolutionary breakthroughs in human tissue and organ regeneration. They gained mainstream attention last summer during the heated debate over whether federal funding should be used to finance the study of stem cells harvested from human embryos.
I In what many pundits labeled a shrewd political compromise, President George W. Bush allowed funding from the National Institutes of Health for research on the approximately 64 colonies of existing embryo cells. Obviously wrestling with the decision (one that displeased many of his more conservative supporters), Bush acknowledged the enticing potential embryonic stem cell research holds for possible medical treatments to replenish diseased organs, but said he did not want taxpayer dollars supporting further destruction of human embryos. The August decision opened new doors for medical research and unlocked the possibility of future business opportunities in the biotech sector. Gerson cautions, however, that Bush's decision is CLEVELAND
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Healtb just the first step in what will undoubtedly be a daunting journey filled with moral and ethical questions that, in many cases, will have to be answered for the first time. In addition to the pubiic-relations quandary, Gerson estimates at least a decade of work will be required to understand the rules of how embryonic stem cells function before that can even be translated into clinical applications rules that have already been established for the mature and umbilical stem cells over the past 20 to 30 years. In light of the recent decision freeing federal funding, however, Gerson says his research group may incorporate embryonic stem cells into its current studies. That process is a protracted one. Gerson will submit a grant proposal to 1 IH in the next six to nine months. It will take another 12 to 15 months before a decision is made. The government will then disburse the NIH research money. "Embryonic stem-cell research is in a discovery stage now," explains Gerson, who is the chief of the division of hematological oncology and associate director for clinical research for the Ireland Can-_._--_._-----
Care Guide has been guiding for nearly Ij years. "I spent a lot of time and energy starting that company," Caplan says. "I can't, at the moment, see doing that again." Nevertheless, with the right business, political and financial support, Caplan says he believes that Cleveland could generate a substantial portion of its biotech industry from enterprises built around stem-cell research. "Whether it's for stem-cell or gene therapy, there's all kinds of technologies sitting at CWRU," he notes, adding that the university is greatly committed to the translation of basic science into entrepreneurial activity. "What we're lacking is efficient and suitable investment and people who are going to follow those technologies up the ladder." The Cleveland Clinic Foundation has also spun off some of its discoveries into commercial ventures, according to George F. Muschler, M.D., director of the bone biology laboratory in the Clinic's department of biomedical engineering. Also a member of the Clinic's department of orthopedic surgery, Muschler's research focuses on understanding the adult stem-cell population present in
cer Center. "I don't use that word lightly, because that's what science is all about: discovering things that we really don't understand and, frankly, this is one of them."
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'''''" of stem-cell research as a source of spin-off business for the biotechnology sector. Recognized as one of the premier stem-cell researchers in Cleveland, Arnold Caplan, Ph.D., professor ofbiology and director of the Skeletal Research Center at CWRU, launched a Cleveland company 10 years ago based on his lab's work in developing the technology for isolating adult mesenchymal stem cells from bone marrow. The firm, Osiris Therapeutics, moved to Baltimore several years later, citing that area as a stronger location for biotechnology ventures. Osiris continues to LIsethe technology license from CWRU to develop products that will affect orthopedics, as well as treat cancer and other diseases, but Caplan is back in Cleveland. He left Osiris near the end of the '90s to concentrate on his center's research, which he .. _--- --'_._-- ------_.- -------------------- _ .._- .. -_._---_._---
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human bone marrow that is an area on which many are contributes to bone formapinning their hopes for help tion. His department has in regenerating damaged already developed a nerve and brain cells. "The regenerative potenpatent-license agreement and a partnership with tial with stem cells is enorDupuy Orthopedics, a mous because there isn't a drug conceivable that would Johnson & Johnson comrestore function after any pany, to improve the way bone-grafting procedures neurodegenerative condition;' he says. are performed in the operating room. Herrup cautions that peoMuschler says there are ple need to separate the still plenty of opportunities short-term promise from the long-term research necessary to develop new applications and potentially even new before any of it might businesses in Cleveland become a reality. pertaining to cartilage, ten"If you ask, 'Can my Aunt "';t~ Josie, who's now in the early don, ligament and muscle 'J,\!,'I ..•.:. stages of Alzheimer's disease, regeneration and improved methods for bone-marrow look to the stem-cell community for help?' the answer is transplantation that relate clearly no," he states. "Can to the technologies his lab is exploring. her daughter? The answer is a very possible yes:' "Existing biotech C0111David Geldmacher, M.D., panies in Cleveland should clinical director of the Unihave greater opportunities to serve as partners and versity Memory Aging Cenparticipate in these develter, concurs with his colleague oping niches for their that the recent events pertainproducts associated with ing to stem-cell research ~' cellular therapy applicashould not elevate it to "silver -.'. tions," he notes. bullet" status. The research UH's Gerson says he trail is going to be a long one. Drs. Stanton Gerson (left), Stephen Haynesworth and Orner Koc study sees potential for technolWhile he prefers not to commature stem cells at University Hospitals of Cleveland. Gerson, who oversees ment on the president's deciogy-transfer opportunities the research, says working with embryonic stem cells may be the next step. sion, Geldmacher does agree from embryonic stem-cell research, but remarks that that all stem-cell experimentation contributes significantly to professor of neuroscience at CWRU's it may take a while to reach the commerAlzheimer's research - even if it only School of Medicine, is confident that as cialization level, since all of the current comes in the form of collateral knowldiscoveries in the nascent stem-cell field research efforts still represent early scienedge about cell functioning that enhances advance, there will be substantial prestific and medical initiatives and not yet our understanding of how to maintain sure to extend the amount oflines availtherapeutic initiatives. He adds that drabrain-cell health. matic medical results will likely first be able, allowing the research to proceed further. "As an example, while the knowledge seen from the study of mature stem cells. "As a scientist, [Bush's decision] was a "Currently, we are able to take bonewe've gained from AIDS research doesn't very disappointing decision, because if marrow stem cells and turn them into always directly help the person who has AlDS today, it has vastly improved our you take it at face value, there's not much bone-marrow cells in patients or turn there to work with," Herrup says. "But if them into brain, lung and liver tissues in knowledge about immune function and ways of manipulating it," offers Geldthe laboratory;' explains Gerson. "None you take a step back and look at it in the of that has been accomplished yet with macher, who conducts experimental drug political context in which this decision embryonic cells, so it's still very early in was made and all that Bush had to juggle, trials to slow the progression of the research for that area." it was a very carefully crafted move." Alzheimer's or improve the mental abilities of people with the disease, He adds In his role, Herrup oversees an active research program that includes a $2 milthat Parkinson's disease, because it is a here is hope that revised federal simpler system than Alzheimer's, attacklion annual NIH grant to operate the Alzheimer's Disease Research Center. guidelines down the road will expeing a relatively restricted portion of the dite advances in embryonic stem-cell brain as opposed to multiple areas Although he is not involved in stem-cell research. Karl Herrup, Ph.D., director of research (his primary focus is studying throughout the brain, is likely to be an the University Memory and Aging Center earlier successful target for stem-cell early neurological development and late at University Hospitals of Cleveland, and treatment. neurodegenerative diseases) he knows it -
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+ Rimas Iasinevicius, executive director of the Cleveland Area Alzheimer's Association, says his organization supports any research that holds significant promise in combating Alzheimer's, The urgency for effective treatments grows every day: Currently, approximately 4 million Americans suffer from the disease, and that number is expected to increase by 50 percent over the next eight years as the population continues to age. "We try not to get hung up in the debate with regards to stem-cell
research," Jasinevicius says. "Rather, we try to enlighten not only our legislators, but the general public about the overall importance of research."
o discussion of the president's decision and the early phases of embryonic stem-cell research can be broached without acknowledging the gorilla in the laboratory closet: the moral and ethical implications of using human embryos. "The president does not have a proper
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moral argument," declares Mary Collingwood, director of the Pro Life Office at the Catholic Diocese of Cleveland. Adamant in the position that human life begins at the moment of conception, Collingwood, the Roman Catholic Church and other right-to-life groups do not allow any wiggle room in interpretation of the topic. It does not matter that the cells were originally created in a petri dish for in vitro fertilization - which they also oppose - or for the express purpose of research and were not extracted from a uterus. "The cells that researchers are now allowed to use were created for the purposes of research," Collingwood says. "So they were created to be destroyed, and that does not respect human life or the dignity of human life." She points out, however, that Pope John Paul II is a strong advocate for continued research with umbilical-cord and mature stem cells. The pope has stated that using embryonic stem cells is unnecessary, especially since the research done in private labs or in other parts of the world to date has not yet delivered on the hopes that were promised early in the process. Still, even if it had, Collingwood says, the end does not justify the means in the eyes of the Catholic Church. For his part, Gerson disagrees with the church's interpretation of when life begins, saying that these cells are for biological experimentation and only represent the creation of human life when implantation occurs in the uterus. Even so, he firmly believes public discussion of such moral and ethical issues should stand at the center of this early phase of embryonic stem-cell research, since citizens need to express their concerns and acquire a clearer understanding of the complex process. "It's not the scientist's right to preempt societal discussion from taking place," Gerson says. Some physicians, such as the Clinic's Muschler, praise President Bush's restrictions as necessary at this point in the research, to quell perceptions that labs might wantonly generate human embryos, then destroy them and produce stem cells for profit. "The decision responsibly walks the balance between respecting human life and not being indiscriminate about the process of using human cells in this way," he says. "But at the same time, it's not so restrictive that it prevents what poten-
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tially are very valuable life-changing therapies from becoming available." Some physicians are a shade less accommodating. Robert Friedland, M.D., for example, finds the right-to-life argument reasonable, and says those who support it should simply not get involved with in vitro fertil; ization or embryonic stem-cell research. But others should be left to pursue the budding research to its fullest extent. , Thus, the pure scientist in him is not overjoyed by the president's restrictions. "Bush's decision is limiting an area with enormous potential for the treatment of brain disorders," Friedland says. "He's not being realistic in implying that the existing stem-cell repositories will be adequate for the purposes of research." A professor of neurology, radiology and psychiatry for the CWRU medical school and University Hospitals, Friedland is currently investigating Alzheimer's disease in a group of Israeli Arabs in which researchers have observed a high incidence of the disease. Gerson claims the president's restrictions are legitimate and prudent. Even though they will hinder researchers, they will also force the NIH to devise important precedents to control research into determining what these cells are and how they function, as well as create oversight, safety and ethical guidelines. Gerson adds that when that groundwork is completed and the medical payoff potential becomes more clearly articulated, perhaps the federal government will see fit to approve additional stemcell lines for research. "Scientists will just have to work a little bit harder to establish the rationale for moving forward," he says. Offering the bioethicist's perspective, Stuart Youngner, M.D., director of the Center for Biomedical Ethics at CWRU, says the public discussion so far has tried to paint the issue in black-and-white terms. Societies sometimes need to make compromises on moral choices for the greater good. He states that with moral issues, the reality often falls somewhere between the two extreme views. Finding common ground on such a controversial issue may be the most difficult task of all. "Most people don't think discarding a lab-created embryo that has 30 undifferentiated cells for research is the same as killing an 8-year-old child," Youngner says. "Most people don't think it's the same as killing an ant, either." _