.. 0 4B8 -. Wednesday, September 29, 2010 // The Statement B months until they complete phase one of the trial, and it's uncertain how long phases two and three may last. And after researching ALS for the last 20 years, Feldman wants to get it right. HOW THEY GOT HERE It wasn't long ago, however, that researchers like Feldman couldn'ttouch stem cells without fear of landing in jail. Before the passage of the Michi- gan Stem Cell Amendment - a bal- lot initiative referred to as Proposal 2 - in November 2008, fertility clinics were forced to throw away unwanted embryos. The 53-47 voter approval gave women in the state the opportu- nity to donate their unwanted embryos to research. The proposal also permit- ted the creation of new embryonic stem cell lines to study diseases and allowed University researchers to transfer their work to the state. Before the proposal passed, Feldman worked three months out of the year in a lab at the University of California at San Diego. Feldman said she made "great strides" in California, where she laid the groundwork for her current ALS clini- cal trial. "But it was difficult managing a labo- ratory nearly 3,000 miles away," she said. "It slowed progress and added unnecessary costs." Besides Election Day, March 9, 2009 stands out as an equally important day for most University researchers. On that Monday, the University announced the opening of the A. Alfred Taubman Medical Research Institute Consortium for Stem Cell Therapies - a $2 mil- lion center housed in the BSRB where University researchers can develop new stem cell lines. Earlier that morn- ing, President Barack Obama issued an executive order that would lift restric- tions on embryonic stem cell research. His announcement overturned former President George Bush's executive orders that limited stem cell research and funding. "This is a great day for America, and a great day for science, and a great day for the University of Michigan," Morrison said in an interview with The Michigan Daily at the time. Today, Feldman calls Obama's deci- sion "a huge triumph for anyone inter- ested in medical science." "It means we can obtain funding for research that will eventually lead to eas- ing the suffering of millions of people afflicted with currently untreatable dis- eases," she said. Before the Michigan Stem Cell Amendment passed, University researchers were only allowed to use human embryonic stem cell lines that had been derived outside of Michigan. Morrison said the regulation posed major problems for research because groups of people like African Ameri- cans, Native Americans and indigenous populations from North and South America were underrepresented in these lines. "The existing embryonic stem cell lines that had been derived in other states don't come close to mirroring the diversity that's present in our society," Morrison said. More than a year and a half old, the consortium is one of a few centers ing research that creates or destroys embryos. The U.S. Justice Department is cur- rently appealing the decision that Mor- rison called a "nuclear bomb" for human embryonic stem cell research. "It's a far more extreme position than we've ever encountered before," Morri- son said. "If that injunction remains in place for a significant period of time, it will destroy the field because there will be no federal support." Wicha also said the injunction is "a big blow" for stem cell research in the United States. If the ruling isn't over- turned, he said, scientists will take their work outside the country. Last year, the National Institutes of Health gave $6.8 million in stimu- lus funds to 13 stem cell research proj- ects at the University. But at least five NIH grants for projects related to the treatment of human diseases will be suspended this year if the injunction "If I'mG going to spend years of mly life trying . p,.e to an swer a q ue stion, I really wa nt people to Care what the answer is" is dangerous for researchers because it requires them to list their names and addresses. "Giving information about the researcher allows some person with a gun and a grudge to come to the lab and start shooting," he said. Any violation of the law would be a felony, punishable up to five years in prison. There would also be a $5,000 fine for failure to submit a report or obtain written consent from an embryo donor. Goldman, who has analyzed the stem cell legislation and has written recom- mendations to Congress, said these additions create a "chilling effect" that will deter researchers from studying stem cells. "Why would someone want to do this research with a possible felony charge hanging over their heads if there was a bookkeeping error?" he said. According to Goldman, no state that permits stem cell research requires the amount of documentation proposed in the bills, nor do any states impose sig- nificant monetary fines for violations. If passed, the amendments may intimidate researchers and force them to again move their work to one of the other 45 states that allow stem cell research, Goldman explained. He added that this would only worsen Michigan's "brain drain" and destroy the opportu- nity for economic gains. The 2008 Michigan Stem Cell Eco- nomics Study, sponsored by the non- partisan public policy institute The Michigan Prospect, found stem cell research could add nearly 4,000 new jobs in the state. University Regent Oliv- ia Maynard (D-Goodrich) is president of The Michigan Prospect. The study also reported that stem cell research has the potential to treat more than 770,000 Michigan residents who suffer from diseases like diabe- tes, ALS, Parkinson's and Alzheimer's. For patients who often take time off from work, stem cell therapies have the potential to cut down sick days and increase employee productiv- ity. According to the study, if annual employee absences decreased 2 per- cent, the state would generate $19.2 million each year. Over 30 years, this would total $576 million. See STEM CELLS, Page 8B * ta 5 a.m. and Eva Feldman is head- ing to her office to devour a hearty breakfast of scientific articles. Over the next two hours she'll sample a bit of cell biology, molecular biology and, her favorite, neurodegenerative diseases. By 8 a.m. Sean Morrison and Max Wicha arrive, and all three begin the tedious task of responding to the hundreds of e-mails they've received through the night. As the morning pro- ceeds they visit their respective labora- tories, which house not only their life's work but also "their people," without whom there would be no work at all. The three, all top scientists at the University, make up some of the prin- cipal players in the most innovative research in the world. Trying to solve more than simple scientific questions, they are on a mission to cure the most torturous and fatal diseases that strike mankind. Wicha runs the University's Com- prehensive Cancer Center. Morrison directs the University's Center for Stem Cell Biology Research as well as the International Society for Stem Cell Research. When they're not on cam- pus they can most always be found in Washington, D.C., Europe or Asia, pre- senting their research at conferences or meeting with international col- leagues - Morrison traveled 135,000 miles least year alone. But Feldman's day, it seems, can be a bit more hectic. On Tuesday she can be found in the Neurology Clinic. Wednesday she's in the Motor Neuron Disease-ALS Clinic treating patients. Other afternoons she's directing the A. Alfred'Taubman Medical Research Institute. For Morrison, Wicha and Feldman, time is their enemy. While they're barely afforded enough of it to breath, the real challenge is working against the clock to develop treatments that may ease the pain and save the lives of millions of people. The answer, they believe, lies in stem cells - microscopic units pres- ent in all multi-cellular species that can regenerate and morph into dif- ferent cells, tissues and organs. While scientists believe stem cells have the potential to treat dozens of diseases and conditions like Alzheimer's, diabe- tes and spinal cord injuries, no one yet knows their full potential. And as researchers try to find out, the clock keeps ticking. "It takes years of your life to answer a scientific question," Morrison says. "So if I'm going to spend years of my life trying to answer a question, I real- ly want people to care what the answer is." Feldman doesn't mind the life com- mitment that eats up her days, hours and seconds. "I don't really have a job,' " she said. "I have a passion. And if you want to call it a job, it's the best job in the world." CLOSE TO A CURE In a laboratory on the fifth floor of the Biomedical Science Research Building, 30 students, Ph.D.s and life- long researchers work ferociously to find a treatment for a ruthless disease - one that creeps through the body, weakening tissues so that victims are, quite literally, unable to move a mus- cle. Even the seemingly most invinci- ble athletes don't sta-d a chance. Meet amyotrophic lateral sclerosis - more commonly known as ALS - or Lou Gerhig's disease, named after the legendary New York Yankees baseball player who suddenly came down with the disease at the height of his career. ALS damages nerve cells and motor neurons in the spinal cord that control muscle movement. The disease tends to strike people in their 30s and 40s, and once a patient is diagnosed it may take only three to five years for the dis- ease to take over the body and kill its host. It's a painful process - as most victims lose the ability to walk, talk and even breath. Feldman, who has seen thousands of ALS patients die from the currently untreatable disease, is on a medical mission to find a cure. "I would say on a near-weekly basis one of my patients will pass away from this disease," she said. "I am very impassioned about understanding ways and means to develop new treat- ments." The 30,000 people in the United States diagnosed with ALS have reason to remain hopeful, however, because Feldman claims she's not too far from a potential cure. In January, Feldman started the first human clinical trial approved by the U.S. Food and Drug Administration. to apply stem cells to treat ALS. Five ALS patients have since volunteered to receive injections of neural stem cells into their spinal cords. Researchers at the University of Michigan study and approve the cells before shipping them to Atlanta where the patients undergo the stem cell transplants at Emory Uni- versity. The majority of the work occurs in Feldman's lab in the Biomedical Sci- ence Research Building, where bottles of solutions, petri dishes and test tubes clutter shelves and rows of DNA-filled refrigerators line the hallways. "I've got more refrigerators than I have shoes," Feldman joked while strutting down a corridor lined with white refrigerators. The trial is still in its first phase and can only move onto phase two when researchers prove the injections cause no harm to the patients. Once safety is established, Feldman and her team will enter the next phase, where they will watch to see if the stem cells actu- ally benefit patients by slowing the progression of the disease. If success- ful, Feldman can recruit more patients for phase three, which, she said, must confirm both safety and efficacy. The goal is to enter 18 patients in the trial, which is receiving stem cells and funding from Neuralstem Inc., a biotech company in Rockville, Md. In an interview in July, Feldman said she was not allowed to comment about the five current patients in the trial. How- ever, she spoke with optimism as she relayed her progress, noting she antici- pates no trouble finding the remaining volunteers. "I think the one really amazing thing about this patient population is how willing they are to step forward and really do something that is brand new, that is clearly experimental - it has never been done before - and they realize that it may not necessarily help them, but it will potentially help other patients with the disease in the future," she said. Feldman believes it may be 14 in the nation where researchers can derive new human embryonic stem cell lines. Since Proposal 2 passed, donated embryos have been slowly trickling through the door. According to Gary Smith, co-director of the Consortium for Stem Cell Thera- pies and an associate professor in the Department of Obstetrics and Gyne- cology, the consortium has received approximately 20 donated embryos from four couples. THE CONTROVERSY ISN'T OVER Though voters approved the 2008 ballot initiative, the fight to impose stem cell research restrictions in Michigan and across the country continues. In August, U.S. District Court Judge Royce Lamberth issued a ruling that blocked federal funding for human embryonic stem cell research. Lam- berth decided that Obama's March 2009 statement violated the Dickey- Wicker Amendment - a federal law that prohibits the government from fund- remains in place, according to Morri- son, who testified before the U.S. Senate this month about how to change federal law to prevent the judge from blocking funding. As researchers await a final decision, the U.S. Court of Appeals ruled yester- day that the government can continue funding human embryonic research while the appeal is pending. Meanwhile, the Michigan state Sen- ate passed a bill in April that amends the . stem cell research guidelines spelled out by Proposal 2. The bill, currently being reviewed by a state House of Represen- tatives committee, proposes new docu- mentation requirements that mandate researchers to write reports about each donated embryo - tracking informa- tion about when it was received, what research was performed and the out- come of any experiments. Ed Goldman, an associate profes- sor in the Department of Obstetrics and Gynecology and an opponent of the legislation, said this type of report Top Photo: JED MOCHDaily Bottom photos from tuft to right: courtesy of Sue OShe MARISSA MCCLAIN/ Daily,. JED MOCH/s L MARISSA MCCLAIN/ Daily