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With 21st Century Cures Act, the Future of Regenerative Medicine Is "Inject and See"

• https://www.wired.com

If Sammy Jo Wilkinson had a spirit animal, it would be Marty McFly. For the past four years, the 51 year-old California resident has been using stem cell therapy to beat her secondary progressive multiple sclerosis back into remission. Gone is the paralysis to the left side of her face and the numbness in her fingers. In February, she walked for the first time in years. "I'm living in a future that everybody will have some day," says Wilkinson, who co-founded the patient's rights group Patients for Stem Cells. "We're trying to tell everybody the solution is here now, we just need a logical way to bring this to patients sooner rather than later."

According to Congress, that logical way is the 21st Century Cures Act, a labyrinthine bill that would make the most significant changes in decades to how medical treatments are tested and brought to market. Politicians are working overtime to pass it before the new year—it's the number one priority for the lame duck session, passing the House on November 30 and advancing through the Senate last night. Final passage is expected to follow later this week.

In some ways, the legislation lives up to its name: It includes ambitious goals to advance biomedical science, and will inject $4.8 billion into a long-stagnating National Institute of Health budget. But attached to those promises is a roadmap for abandoning the gold standard of medicine in favor of an expedited "middle path" for drugs, medical devices, and regenerative therapies. Critics say it's deregulation in sheep's clothing—and worry that both science and patients are going to suffer.

Whether you applaud or decry the legislation, it's almost certain to pass and be signed into law, if not by President Obama, then by the incoming administration. Which means regenerative medicine is headed for prime time. Welcome to the era of "inject and see."

Medicine's Wild West

In 2012, Wilkinson flew to Houston to receive her first stem cell treatment at Celltex Therapeutics. Technicians there extracted adult stem cells from her fat tissue, then cultured them for 13 days, allowing the population to expand before injecting the cells back into Wilkinson. The effects, she says, were immediate. She had less pain, more energy. But a few months later, the US Food and Drug Administration ruled that Celltex was violating a 2006 rule change that allowed the FDA to regulate expanded cell populations as drugs. They would need to get agency approval before being used in treatments.

These actions became the most visible confrontation in a bitter, decade-long battle between regulators and patients regarding the legality of regenerative therapies. While some companies, like Celltex, moved their operations to Mexico to skirt regulations, other small clinics with lower profiles rushed to fill the void. The FDA has been slow to investigate the proliferation of these clinics and the therapies they market. Today there are close to 600 businesses in America selling stem cell solutions for everything from deafness to Alzheimer's and autism, all without FDA approval, according to a study published in February by Paul Knoepfler and Leigh Turner.

Turner, who is a bioethicist at the University of Minnesota, was surprised by the scale of exploitative behavior he found. "Anyone can buy a domain name and create a website and make grandiose therapeutic claims that have no basis in reality whatsoever," he says. The situation has prompted scientists and policy wonks to dub stem cell clinics "medicine's wild west."


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