Positive results from stem cell therapy are seen usually within a month, and patients can request another treatment about 6 months after the first treatment presently.
This stem cell paradigm of therapy addresses the etiology of a disease state, instead of focusing on the symptoms only. As such, this is the practice of regenerative medicine with the implementation of SCT.
Some believe ethical restraints are needed regarding the use of ESCs for therapeutic reasons. Yet they improve the quality of life of those with devastating diseases which involves suffering without any relief.
So stem cell therapy and research may be the most right and ethical thing to do for such patients. Not only is the tremedous suffering relieved with those possessed with devistating diseases, their functional ability is restored for those who receive stem cell therapy.
Embryos are acquired from fertility clinics (IVFs) that have thousands routinely stored and are abnormally fertilized. This means that they could never go on to become a human, and would be destroyed otherwise.
Ironically, one could argue it is inappropriate to discard what may be valuable and ethical for others, potentially.
Most couples with frozen embryos would gladly give them to such research, surveys have concluded.
These embryos are believed by many to not be morally equivalent to human life, but only have the potential for life. And they are used for therapeutic cloning, known as somatic cell nuclear transfer, and not reproductive cloning.
Ten states have banned this cloning out of ignorance, it seems. Bioethic principles, which are beneficience, or physician-centered decisions, as well as non-maleficence, which is first do no harm, are not corrupted.
Furthermore, autonomy, which is the patient???s right to determine their health, and justice or fairness remain intact.
Stem cells should be utilized for those terminally ill as well, many believe. Many are seeking stem cell therapy overseas due to restrictions that exist in the U.S. presently. The United Kingdom is believed to be the leader in stem cell research presently.
Dan Abshear
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The Whole World Is Watching
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Keirstead's animal research was published in a peer-reviewed journal, but much of Geron's other preclinical documentation has been under wraps; only the company and the FDA know what it says. That leaves some researchers feeling unsettled. What's the precise mechanism of action? Could the cells prompt an immune response in patients? Or generate certain fibers that cause pain? Should Geron perform experiments in other types of animals before they go to humans? John Gearhart, a pioneering researcher whose early stem-cell work was funded by Geron and who is now director of the Institute for Regenerative Medicine at the University of Pennsylvania, says he wants the trial to succeed, but he constantly worries about safety. Gearhart wonders if there might not be some number of cells in Geron's therapy that don't behave as scientists want them to—they don't differentiate themselves into the desired cell type after they're injected. Research has shown that such cells may form tumors or interfere with normal function, and it is difficult to say for sure how many months or years later that might occur. For Larry Goldstein, director of the University of California, San Diego, stem-cell program, a key issue is risk versus benefit. While paraplegia is by no means easy to endure, people do adapt and can have fulfilling lives. What if the treatment causes harm? Ideally, Goldstein would have liked the first human embryonic-stem-cell therapy tested in a disease that leads inexorably to death, like ALS. "I'm nervous," he says. This first trial is "a high-wire act."
Geron's CEO, Dr. Thomas Okarma, says he understands the anxiety. "Nobody wants another Jesse Gelsinger here," he says, referring to the teen who died in a 1999 trial for gene therapy, another pioneering technique. The company, he says, has "lifted stones as far and high as we can to assure ourselves the safety of this product." The oligodendrocyte cells it is injecting (each patient will receive a syringe of 2 million cells) are "highly characterized," meaning it's seen no evidence of any outliers that might cause trouble down the road. Its tests found no tumors in rodents over the course of a year and no evidence of an immune response (patients will be given immunosuppressants for 45 to 60 days after treatment, but that's to be sure there's no inflammation in the injury site, which might destroy the injected cells).
Patients will be closely monitored with MRIs for the first year and followed for a total of 15 years. And trial volunteers will have complete injuries "with no hope of recovery," making the risk worth the potential payoff, says Okarma. Geron's mantra is "living cells will be tomorrow's pills," he says. And he is confident it will get there. So confident, he believes the oligodendrocyte progenitor cells might be applicable to other nervous-system disorders, like multiple sclerosis, Alzheimer's and stroke. Geron plans to publish more of its preclinical data, Okarma says, but in the meantime, the public should be assured that the company has done rigorous research. "Companies die when they're not successful, when a product is harmful or it doesn't work," he says. "The last thing we want to do is be wrong. The future of the company depends on this." Keirstead, for his part, says the first thing he asks when people say "slow down" is "Do you know anyone in a wheelchair?'"
Everybody wants to be cautious, but researchers, clinicians, patients and biotechs differ on how much risk they can live with and when to pull the trigger. Gearhart says his conservative approach butts up against others in the field. "Every time I say 'be circumspect,' my clinical friends are hitting me upside the head, saying, 'You've got to do it at some point'." That is the view of Dr. Gary Steinberg, a professor of neurosurgery at Stanford, a potential site for Geron's trial. "I'm highly enthusiastic," he says. Steinberg says he has faith in the FDA's review. Without effective treatments currently available, patients with spinal-cord injuries are left with little recourse. "There's a significant unmet need," he says. At the Miami Project to Cure Paralysis, scientific director W. Dalton Dietrich says he has concerns—this is a first, after all—but he also believes researchers will learn a great deal about how to use cellular therapies in humans, something that will help educate and advance the field.
Daniel Tratt, 30, would love for that to happen. Tratt was paralyzed from the ribcage down as a college student 10 years ago when he fell over a stairway banister and dropped 23 feet. The first year was agonizing, as Tratt suffered from denial and depression. Today he's got two graduate degrees, is a special-ed teacher in New York City and has completed a triathlon using a handcycle and a racing chair. Tratt says he's not ready to volunteer for a clinical trial—he's worked too hard to get to where he is to risk any possible setback. Still, while he gets plenty of joy out of his life, he would be "elated" if one day there were a treatment that could improve his mobility and restore some function. "That's what most people in the spinal-cord community can only dream of."
Which is why it's so critical to be realistic. Geron has to show that its product is safe—the earliest the company might release preliminary data is 2010—before it can start officially testing its efficacy. What works in rats may fail in humans. And the treatment isn't intended for any of the 400,000-plus people who have chronic spinal-cord injuries now; another therapy—researchers are pursuing various cellular approaches—may prove more helpful down the road. The Reeve Foundation's Kiernan says people need to focus more on the process than on the event. "This safety study has taken on outsized import," he says. In the end, what matters most is how Geron and everybody else interprets what happens—good or bad. "Success doesn't mean we've made it, and failure doesn't mean we've lost it," Kiernan says. "We're at the very, very beginning."
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