The Food and Drug Administration has launched a nationwide crackdown on stem-cell clinics, issuing letters of warning and threatening civil actions that could shut them down if they refuse to comply with FDA regulations.
On Wednesday, the FDA sent correspondence to 20 clinics around the country, putting them on notice that they must seek FDA review and approval for their procedures.
Over the past 12 months, the FDA has sent “regulatory correspondence” to 45 clinics, according to The New York Times, which refers to them as “rogue stem-cell clinics.”
The regulatory crackdown is a paradigm change for more than 700 stem-cell clinics nationwide that have largely gone unregulated by federal authorities for over a decade.
The procedures being scrutinized include those that concentrate a patient’s own stem cells and re-inject them into that patient to treat a wide range of painful, debilitating illnesses such as herniated disks, joint pain, reproductive issues, Parkinson’s disease, multiple sclerosis, and several others.
The FDA has filed civil actions against two clinics, one in Florida and another in California, in a bid to force them to comply with FDA regulatory regimes applied to major drug manufacturers. That would likely be unsustainable for small practices.
Advocates for regenerative stem-cell medicine charge that Big Pharma’s influence is behind the crackdown, suggesting the FDA is being used to clear out potential competitors. They describe stem-cell therapy as a minimally invasive procedure best regulated by local medical boards.
The clinics maintain that because many of the treatments involve harvesting a patient’s own stem cells – known as autologous stem cells – and then re-injecting them into trouble spots in that patient’s own body, they should not be subject to FDA regulation.
Stem cells are undifferentiated, meaning they have the potential to grow into multiple types of bodily tissues. The clinics that use them in treatments maintain they reduce inflammation and promote healing.
Stem cells, they say, have been successfully used to treat thousands of patients, while critics point to cases where patients had adverse reactions – including three Florida seniors with macular generation who reportedly suffered “severe vision loss” after stem-cells were injected into their eyes in a clinical trial, as reported in a March 2017 article in the New England Journal of Medicine.
One factor in the growing controversy: The question of when a procedure involving one’s own tissues comes under the purview of federal regulators. Libertarian-minded medical ethicists argue the government should not be empowered to regulate patients’ decisions about their own medical treatment when it involves materials taken from, and reintroduced into, their own bodies.
Dr. Jeff Singer, a general surgeon in Phoenix who also serves as a senior fellow at the libertarian Cato Institute think tank, tells Newsmax that the FDA refrains from regulation in what’s known as “same surgery,” when a tissue is removed from one part of the body and introduced somewhere else in the same patient. A skin graft would be an example.
But if the tissue is manipulated in some way, it begins to attract the FDA’s attention, in part due to the concern the tissue could be somehow contaminated during the handling process.
“If it’s what they call not the ‘same surgery’ – for example you take it and process it and then later on reinsert it into the patient – they consider that sort of a creation of a drug, and they claim to have regulatory authority over it,” Singer says.
This demarcation is particularly relevant in the case of adipose stem-cell treatments -- that is, stem cells that are derived from fatty deposits in the human body.
The procedure can be performed in just two hours under local anesthesia. An amount of fat approximately equivalent to a stick of butter is removed from the body. Enzymes are added to help the stems cells detach from the fat cells. The fatty material is then spun in a centrifuge to separate out stem cells, which are then collected and re-injected into the treatment areas of the patient.
Singer comments: “The FDA considers that sort of like creating a medicine, and therefore it needs to come under their regulatory jurisdiction before it’s approved – that’s their position on it.”
Singer would like the FDA to limit itself to certifying whether an autologous procedure has been proven to be safe and effective.
“For example,” he says, “if the FDA wanted to say, ‘We haven’t certified that this process is safe, proceed at your own risk,’ I’m ok with that. But I still want to be able to make my own decision.”
Of course patient safety is very important to Singer, but he points out federal regulators are hardly beyond making errors of their own. And he says the principle that the patient, not the government, must ultimately decide his or her own care also must be protected.
As Singer tells Newsmax: “If I want to take my own tissue – my own, not someone else’s – prepare it a certain way, and then put it back in my own body, that’s as sacred as my right to free speech. From a medical ethics standpoint, it’s a patient autonomy question.”
That the FDA sees things differently has become increasingly evident in recent years. Last December, for example, it issued a news release that warned: “Time is running out for firms to come into compliance during our period of enforcement discretion. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”
Perhaps no one in the stem-cell regenerative medicine business has come under greater scrutiny than Dr. Kristin Comella, chief science officer of U.S. Stem Cell, a firm that operates three clinics in South Florida.
Comella has helped train over 700 practitioners in her company’s adipose stem-cell methodology, and U.S. Stem Cell has been recognized as a leader in its industry. Comella says the FDA’s bid to regulate what patients choose to do with their own tissues is a case of regulatory overreach.
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