The Food and Drug Administration has put questionable stem cell clinics on notice.
The agency announced plans Monday for new policies and law enforcement efforts to get rid of what he calls “unscrupulous actors” selling unproven, dangerous, and often expensive stem cell therapies—including the shocking and troubling example of a small vaccine.
As an early demonstration of its tough stance, the agency today released information on two enforcement efforts. There was one a warning letter to a Florida stem cell clinic that has been exposed as a legitimate clinical trial that ended up blinding three patients after injecting stem cells directly into their eyes. Others ate it by notifying that the agency has received five vials of the vaccine from stem cell clinics in California.
The clinics, owned by StemImmune Inc. is working, is said to be combining a dangerous vaccine with stem cells for an unproven, unapproved, and potentially harmful cancer treatment that is injected into patients or directly into their tumors. Although the injection of stem cells alone lacks safety and efficacy data, the vaccine is known to be dangerous. The vaccine contains live poxvirus, which is similar to but less harmful than small pox. When injected into patients with weakened immune systems—such as many cancer patients—the vaccine can cause dangerous side effects, such as heart swelling.
In today’s announcement, the agency noted that the vaccine, Live Vaccine (Live), is not commercially available. It is reserved for people who are at high risk of infection by an otherwise deleted virus, such as researchers or military personnel. “The FDA has serious concerns about StemImmune’s approval of the product for use as part of an unapproved and dangerous treatment,” the agency said. The FDA added that it is actively investigating the origins of the vials.
At least some of the vials came from the Centers for Disease Control and Prevention, according to CDC spokesman Thomas Skinner. In an interview with Ars, Skinner explained that private and public companies around the country can apply for the vaccine and that the agency has rules and regulations governing how it is distributed. According to Skinner, StemImmune has told the CDC that it needs the vaccine to protect some of its own researchers.
But in the FDA announcement, the agency reported that it has confirmed that StemImmune is actually using the vaccine in cancer patients. The FDA said that, of the five vials received, four were intact and one was partially used. The agency is investigating where the other vials came from and how StemImmune obtained them.
In an email to Ars, StemImmune did not respond to questions about the FDA’s safety concerns or the origins of the vaccine vials. The company provides this information:
StemImmune, a biopharmaceutical company engaged in cutting-edge R&D of human stem cell-based therapies for the treatment of cancer, is fully cooperating with the FDA regarding the development of stem cell-based cancer therapy. We look forward to continuing our dialogue with the FDA as we seek to bring this important cancer therapy to cancer patients.
As for the Florida stem cell clinic, US Stem Cell, the FDA warns that it is marketing products without FDA approval. The hospital also had “significant deviations from current good manufacturing practice requirements, including some that could affect the sterility of their products, putting patients at risk,” according to the FDA.
In a statement emailed to Ars, US Stem Cell responded:
The safety and health of our patients is our number one priority, and we have strict standards in place following the Food and Drug Administration. Since November 2014, we have given the FDA unlimited access to our materials and our processes and will continue to work with them as it relates to clinical and industrial improvements. The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017, and we intend to follow those standards as well.
Fruits that are small?
Questionable and harmful clinics like those operated by StemImmune and US Stem Cell have proliferated in the US, according to researchers. A study last year of nearly 600 clinics across the country claimed to treat everything from autism to Parkinson’s disease, low back pain, mental health conditions, and more. disease.
In today’s announcement, FDA Commissioner Scott Gottlieb spoke firmly about harming those hospitals and their treatments:
Speaking as a cancer survivor, I know all too well the fear and anxiety a cancer diagnosis can have on a patient and their loved ones and how tempting it can be to believe the bold but ultimately empty promises of such careless hospitals. These or others are selling so-called cures… The FDA will not allow fraudsters to take advantage of vulnerable patients by claiming to have treatments or cures for serious illnesses. without any proof that they actually work.
But Leigh Turner, a bioethicist at the University of Minnesota who has extensively researched these stem cell clinics (and published a study last year evaluating the clinics), is hesitant to say this is the beginning of the end for injury treatments. “In some ways, I’m encouraged by today’s developments,” he told Ars when contacted by phone. Implementation efforts and plans for new policies and work groups are positive signs.
But, there had been “bold statements” before about disturbances and nothing had happened since, he said. “And so, one question from me is — assuming (the FDA will) do something — are we going to see a more systematic, comprehensive, kind of organized approach to what seems like a major problem in the marketplace? Or will we see a more ‘low-hanging fruit’ approach,” in which the FDA goes after major issues following numerous complaints, media investigations, reports of injuries, or lawsuits, etc. .
“It’s good to see the FDA do something,” Turner said, but not when it’s on the backs of people who are seriously injured.