With a new year and a new White House administration just around the corner, some experts in the field of stem cell science say it's unclear whether proposed regulations of unproven and expensive stem cell treatments will move forward.
The growing stem cell treatment industry, including a number of San Diego firms, has faced criticism from scientists over its lack of published data to support therapies that often cost patients thousands, and even tens of thousands of dollars.
Hundreds of clinics around the country now advertise stem cell treatments for everything from autism to multiple sclerosis, despite disclaimers on their websites noting that these treatments are not approved by the Federal Drug Administration.
Last month, FDA officials published an article in the New England Journal of Medicine that seemed to signal increased attention toward the issue.
They wrote that beyond the well-established use of stem cells for certain disorders such as leukemia, "The assertion that stem cells are intrinsically able to sense the environment into which they are introduced and address whatever functions require replacement or repair — whether injured knee cartilage or a neurologic deficit — is not based on scientific evidence."
"This lack of evidence is worrisome," the FDA officials wrote. They cited the experience of people harmed by such treatments, including Jim Gass, a stroke patient KPBS recently profiled.
Gass reached out to a number of stem cell companies — including San Diego-based Stemedica — seeking treatments outside the country. He hoped stem cells would help him regain some mobility, but he ended up developing a strange tumor that increased his paralysis.
UC Davis stem cell scientist Paul Knoepfler says if the FDA is serious about better regulating these treatments, they should consider moving forward with their plans before Donald Trump enters the White House.
"Trump is probably going to be less supportive of the FDA taking some kind of major action on stem cell clinics," said Knoepfler, who recently wrote an open letter calling on the FDA to act now.
Trump's plan for his first 100 days in office discusses his plans for "cutting the red tape at the FDA" and his desire to "speed the approval of life-saving medications."
"It just seems like in the next month or so, there would be a more straightforward political environment to take some kind of action," Knoepfler said. "I do think it's a period of uncertainty."
Meanwhile, at least one San Diego stem cell treatment company is cheering recent legislation it believes will "positively impact" stem cell therapies.
Earlier this week, La Jolla-based Stemgenex applauded the passage of the 21st Century Cures Act, which calls on the FDA to incorporate "real world evidence" into its approval process. Some experts see that as a lower standard than the randomized clinical trials which are typically required for the approval of new drugs.
Stemgenex's chief administrative officer Rita Alexander is quoted in a press release saying, "This important piece of legislation will potentially unleash many more treatment options, including stem cell treatment, to those suffering with incurable diseases."
Stemgenex is currently facing a lawsuit from dissatisfied patients who allege they paid the company nearly $15,000 for ineffective and falsely advertised treatments.
