unlocked cells

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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. I naspacious biomedical research lab- oratory 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 tis- sue-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, Ger- son's lab can find stem cells, determine what sort of tissue they match, separate and grow them, by Christopher Johnston 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 revolution- ary breakthroughs in human tissue and organ regeneration. They gained main- stream 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. 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. Obvi- ously wrestling with the decision (one that displeased many of his more conser- vative 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 oppor- tunities in the biotech sector. Gerson cautions, however, that Bush's decision is CLEVELAND 139 i~ i " I: !: r I II r

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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. By Christopher Johnston Cleveland Magazine

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Page 1: Unlocked Cells

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.

Ina spacious biomedical research lab-oratory at University Hospitals ofCleveland's Ireland Cancer Center,

Stanton Gerson, M.D., directs more thana dozen physicians and scientists. Eachday, they marshal the tools of their tradeto 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 tis-sue-culture incubator, one researcherpeers into a confocal microscope totrack intracellular proteins; anotheremploys customized laser equipment toscan the surface of individual cells forspecial biological markers. Through aseries of sophisticated procedures, Ger-son's lab can find stem cells, determinewhat sort of tissue they match, separateand grow them,

by Christopher Johnston

Gerson oversees cell and gene therapyresearch at University Hospitals and theCase Western Reserve University Schoolof Medicine. His research focuses onstem cells derived from bone marrow fortransplants - hematopoietic stem cells,which become blood and bone marrowcells, and mesenchymal stem cells, whichbecome bone, cartilage, tendon, muscleand other connective tissues in the body.

Though microscopic in size, stemcells are the centerpiece of research thatmany anticipate will lead to revolution-ary breakthroughs in human tissue andorgan regeneration. They gained main-stream attention last summer during theheated debate over whether federalfunding should be used to finance thestudy of stem cells harvested fromhuman embryos.

In what many pundits labeled ashrewd political compromise, PresidentGeorge W. Bush allowed funding fromthe National Institutes of Health forresearch on the approximately 64colonies of existing embryo cells. Obvi-ously wrestling with the decision (onethat displeased many of his more conser-vative supporters), Bush acknowledgedthe enticing potential embryonic stemcell research holds for possible medicaltreatments to replenish diseased organs,but said he did not want taxpayer dollarssupporting further destruction ofhuman embryos.

The August decision opened newdoors for medical research and unlockedthe possibility of future business oppor-tunities in the biotech sector. Gersoncautions, however, that Bush's decision is

CLEVELAND 139

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Page 2: Unlocked Cells

Healtb Care Guidejust the first step in what will undoubt-edly be a daunting journey filled withmoral and ethical questions that, inmany cases, will have to be answered forthe first time.

In addition to the pubiic-relationsquandary, Gerson estimates at least adecade of work will be required tounderstand the rules of how embryonicstem cells function before that can evenbe translated into clinical applications -rules that have already been establishedfor the mature and umbilical stem cellsover the past 20 to 30 years. In light ofthe recent decision freeing federal fund-ing, however, Gerson says his researchgroup may incorporate embryonic stemcells into its current studies. That processis a protracted one. Gerson will submit agrant proposal to 1 IH in the next six tonine months. It will take another 12 to15 months before a decision is made.The government will then disburse theNIH research money.

"Embryonic stem-cell research is in adiscovery stage now," explains Gerson,who is the chief of the division of hema-tological oncology and associate directorfor clinical research for the Ireland Can-

cer Center. "I don't use that wordlightly, because that's what science is allabout: discovering things that we reallydon't understand and, frankly, this isone of them."

has been guiding for nearly Ij years. "Ispent a lot of time and energy startingthat company," Caplan says. "I can't, atthe moment, see doing that again."

Nevertheless, with the right business,political and financial support, Caplansays he believes that Cleveland couldgenerate a substantial portion of itsbiotech industry from enterprises builtaround stem-cell research.

"Whether it's for stem-cell or genetherapy, there's all kinds of technologiessitting at CWRU," he notes, adding thatthe university is greatly committed to thetranslation of basic science intoentrepreneurial activity. "What we'relacking is efficient and suitable invest-ment and people who are going to followthose technologies up the ladder."

The Cleveland Clinic Foundation hasalso spun off some of its discoveries intocommercial ventures, according toGeorge F. Muschler, M.D., director of thebone biology laboratory in the Clinic'sdepartment of biomedical engineering.Also a member of the Clinic's depart-ment of orthopedic surgery, Muschler'sresearch focuses on understanding theadult stem-cell population present in

f'''' leveland has already seen the promise'''''" of stem-cell research as a source ofspin-off business for the biotechnologysector. Recognized as one of the premierstem-cell researchers in Cleveland,Arnold Caplan, Ph.D., professor ofbiol-ogy and director of the Skeletal ResearchCenter at CWRU, launched a Clevelandcompany 10 years ago based on his lab'swork in developing the technology forisolating adult mesenchymal stem cellsfrom bone marrow. The firm, OsirisTherapeutics, moved to Baltimore severalyears later, citing that area as a strongerlocation for biotechnology ventures.

Osiris continues to LIsethe technologylicense from CWRU to develop productsthat will affect orthopedics, as well astreat cancer and other diseases, butCaplan is back in Cleveland. He leftOsiris near the end of the '90s to concen-trate on his center's research, which he

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Page 3: Unlocked Cells

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human bone marrow thatcontributes to bone forma-tion. His department hasalready developed apatent-license agreementand a partnership withDupuy Orthopedics, aJohnson & Johnson com-pany, to improve the waybone-grafting proceduresare performed in the oper-ating room.

Muschler says there arestill plenty of opportunitiesto develop new applicationsand potentially even newbusinesses in Clevelandpertaining to cartilage, ten-don, ligament and muscleregeneration and improvedmethods for bone-marrowtransplantation that relateto the technologies his labis exploring.

"Existing biotech C0111-

panies in Cleveland shouldhave greater opportunitiesto serve as partners andparticipate in these devel-oping niches for theirproducts associated withcellular therapy applica-tions," he notes.

UH's Gerson says hesees potential for technol-ogy-transfer opportunitiesfrom embryonic stem-cellresearch, but remarks thatit may take a while to reach the commer-cialization level, since all of the currentresearch efforts still represent early scien-tific and medical initiatives and not yettherapeutic initiatives. He adds that dra-matic medical results will likely first beseen from the study of mature stem cells.

"Currently, we are able to take bone-marrow stem cells and turn them intobone-marrow cells in patients or turnthem into brain, lung and liver tissues inthe laboratory;' explains Gerson. "Noneof that has been accomplished yet withembryonic cells, so it's still very early inthe research for that area."

-.'.~' -

There is hope that revised federalguidelines down the road will expe-

dite advances in embryonic stem-cellresearch. Karl Herrup, Ph.D., director ofthe University Memory and Aging Centerat University Hospitals of Cleveland, and

142 DECEMBER 2001

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professor of neuroscience at CWRU'sSchool of Medicine, is confident that asdiscoveries in the nascent stem-cell fieldadvance, there will be substantial pres-sure to extend the amount oflines avail-able, allowing the research to proceedfurther.

"Asa scientist, [Bush's decision] was avery disappointing decision, because ifyou take it at face value, there's not muchthere to work with," Herrup says. "But ifyou take a step back and look at it in thepolitical context in which this decisionwas made and all that Bush had to juggle,it was a very carefully crafted move."

In his role, Herrup oversees an activeresearch program that includes a $2 mil-lion annual NIH grant to operate theAlzheimer's Disease Research Center.Although he is not involved in stem-cellresearch (his primary focus is studyingearly neurological development and lateneurodegenerative diseases) he knows it

is an area on which many arepinning their hopes for helpin regenerating damagednerve and brain cells.

"The regenerative poten-tial with stem cells is enor-mous because there isn't adrug conceivable that wouldrestore function after anyneurodegenerative condi-tion;' he says.

Herrup cautions that peo-ple need to separate theshort-term promise from thelong-term research necessarybefore any of it mightbecome a reality.

"If you ask, 'Can my AuntJosie, who's now in the earlystages of Alzheimer's disease,look to the stem-cell commu-nity for help?' the answer isclearly no," he states. "Canher daughter? The answer is avery possible yes:'

David Geldmacher, M.D.,clinical director of the Uni-versity Memory Aging Cen-ter, concurs with his colleaguethat the recent events pertain-ing to stem-cell researchshould not elevate it to "silverbullet" status. The researchtrail is going to be a long one.While he prefers not to com-ment on the president's deci-sion, Geldmacher does agreethat all stem-cell experimen-

tation contributes significantly toAlzheimer's research - even if it onlycomes in the form of collateral knowl-edge about cell functioning that enhancesour understanding of how to maintainbrain-cell health.

"Asan example, while the knowledgewe've gained from AIDS research doesn'talways directly help the person who hasAlDS today, it has vastly improved ourknowledge about immune function andways of manipulating it," offers Geld-macher, who conducts experimental drugtrials to slow the progression ofAlzheimer's or improve the mental abili-ties of people with the disease, He addsthat Parkinson's disease, because it is asimpler system than Alzheimer's, attack-ing a relatively restricted portion of thebrain as opposed to multiple areasthroughout the brain, is likely to be anearlier successful target for stem-celltreatment.

"Ero

"""

Drs. Stanton Gerson (left), Stephen Haynesworth and Orner Koc studymature stem cells at University Hospitals of Cleveland. Gerson, who overseesthe research, says working with embryonic stem cells may be the next step.

Page 4: Unlocked Cells

research," Jasinevicius says. "Rather, wetry to enlighten not only our legislators,but the general public about the overallimportance of research."

Rimas Iasinevicius, executive directorof the Cleveland Area Alzheimer's Asso-ciation, says his organization supportsany research that holds significantpromise in combating Alzheimer's, Theurgency for effective treatments growsevery day: Currently, approximately 4million Americans suffer from the dis-ease, and that number is expected toincrease by 50 percent over the next eightyears as the population continues to age.

"We try not to get hung up in thedebate with regards to stem-cell

No discussion of the president's deci-sion and the early phases of embry-

onic stem-cell research can be broachedwithout acknowledging the gorilla in thelaboratory closet: the moral and ethicalimplications of using human embryos.

"The president does not have a proper

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moral argument," declares Mary Colling-wood, director of the Pro Life Office atthe Catholic Diocese of Cleveland.

Adamant in the position that humanlife begins at the moment of conception,Collingwood, the Roman CatholicChurch and other right-to-life groups donot allow any wiggle room in interpreta-tion of the topic. It does not matter thatthe cells were originally created in a petridish for in vitro fertilization - whichthey also oppose - or for the expresspurpose of research and were notextracted from a uterus.

"The cells that researchers are nowallowed to use were created for the pur-poses of research," Collingwood says. "Sothey were created to be destroyed, andthat does not respect human life or thedignity of human life."

She points out, however, that PopeJohn Paul II is a strong advocate for con-tinued research with umbilical-cord andmature stem cells. The pope has statedthat using embryonic stem cells is unnec-essary, especially since the research donein private labs or in other parts of theworld to date has not yet delivered on thehopes that were promised early in theprocess. Still, even if it had, Collingwoodsays, the end does not justify the meansin the eyes of the Catholic Church.

For his part, Gerson disagrees withthe church's interpretation of when lifebegins, saying that these cells are for bio-logical experimentation and only repre-sent the creation of human life whenimplantation occurs in the uterus. Evenso, he firmly believes public discussion ofsuch moral and ethical issues shouldstand at the center of this early phase ofembryonic stem-cell research, since citi-zens need to express their concerns andacquire a clearer understanding of thecomplex process.

"It's not the scientist's right to pre-empt societal discussion from takingplace," Gerson says.

Some physicians, such as the Clinic'sMuschler, praise President Bush's restric-tions as necessary at this point in theresearch, to quell perceptions that labsmight wantonly generate humanembryos, then destroy them and producestem cells for profit.

"The decision responsibly walks thebalance between respecting human lifeand not being indiscriminate about theprocess of using human cells in this way,"he says. "But at the same time, it's not sorestrictive that it prevents what poten-

Page 5: Unlocked Cells

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tially are very valuable life-changingtherapies from becoming available."

Some physicians are a shade lessaccommodating.

Robert Friedland, M.D., for example,finds the right-to-life argument reason-able, and says those who support it shouldsimply not get involved with in vitro fertil-

; ization or embryonic stem-cell research.But others should be left to pursue thebudding research to its fullest extent.

, Thus, the pure scientist in him is not over-joyed by the president's restrictions.

"Bush's decision is limiting an areawith enormous potential for the treat-ment of brain disorders," Friedland says."He's not being realistic in implying thatthe existing stem-cell repositories will beadequate for the purposes of research."

A professor of neurology, radiologyand psychiatry for the CWRU medicalschool and University Hospitals, Fried-land is currently investigatingAlzheimer's disease in a group of IsraeliArabs in which researchers haveobserved a high incidence of the disease.

Gerson claims the president's restric-tions are legitimate and prudent. Eventhough they will hinder researchers, theywill also force the NIH to devise impor-tant precedents to control research intodetermining what these cells are andhow they function, as well as create over-sight, safety and ethical guidelines. Ger-son adds that when that groundwork iscompleted and the medical payoffpotential becomes more clearly articu-lated, perhaps the federal governmentwill see fit to approve additional stem-cell lines for research.

"Scientists will just have to work a lit-tle bit harder to establish the rationalefor moving forward," he says.

Offering the bioethicist's perspective,Stuart Youngner, M.D., director of theCenter for Biomedical Ethics at CWRU,says the public discussion so far has triedto paint the issue in black-and-whiteterms. Societies sometimes need to makecompromises on moral choices for thegreater good. He states that with moralissues, the reality often falls somewherebetween the two extreme views. Findingcommon ground on such a controversialissue may be the most difficult task of all.

"Most people don't think discarding alab-created embryo that has 30 undiffer-entiated cells for research is the same askilling an 8-year-old child," Youngnersays. "Most people don't think it's thesame as killing an ant, either." _