Attorney General Letitia James of New York said on Thursday that she had filed a lawsuit against a for-profit stem cell clinic, Park Avenue Stem Cell, claiming it performed unproven, rogue procedures on patients with a wide range of medical conditions, from erectile dysfunction to heart disease.
“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral,” Ms. James said in a statement. “We will continue to investigate these types of clinics that shamelessly add to the suffering of these consumers by charging them thousands of dollars for treatments that they know are ineffective.”
The lawsuit is part of the attorney general’s broader look at dubious medical claims being made by stem cell clinics in New York. It comes on the heels of repeated attempts to crack down on the stem cell industry by the Food and Drug Administration, which warned nearly two dozen clinics earlier this week to stop selling treatments that could harm patients.
The clinics have proliferated around the country, despite a lack of evidence that would support claims that stem cell injections can repair aging joints or regenerate tissue.
Situated in Midtown Manhattan, Park Avenue Stem Cell is operated by Dr. Joel B. Singer, a plastic surgeon who has previously run afoul of state regulators, according to the state attorney general’s office. Phone calls and emails to Dr. Singer and his lawyer were not returned.
According to state regulators, Park Avenue Stem Cell also had ties to a California business, Cell Surgical Network, with roughly 100 affiliates around the country, that was sued by the F.D.A. last year. The federal agency is seeking a permanent injunction against Cell Surgical Network, according to state officials, who say the clinic followed the network’s procedures until its affiliation ended last December
Stem cells, derived from cells found in blood, fat or birth tissue, offer promise as a potential treatment to repair damage from injury to disease. But regulators have become increasingly concerned that many of the claims made by the companies and clinics offering stem cell treatments have far outpaced the available medical evidence.
Like the New York clinic, many of these clinics offer people treatments that cost thousands of dollars, which patients typically pay out of pocket because health insurers refuse to cover the therapies. Some products have proved dangerous to patients, blinding some and causing severe infections in at least a dozen people.
In the case of Park Avenue Stem Cell, patients were treated with stem cells taken from their own adipose tissue, or fat.
“Defendants claim that they can treat a variety of serious medical conditions, including but not limited to, urologic diseases and erectile dysfunction, neurology diseases, cardiac/pulmonary disease, autoimmune diseases, and orthopedic conditions, even through there is currently no adequate scientific substantiation that these treatments will be effective; in fact, they could be harmful,” according to the lawsuit.
On its website, the clinic promotes what it describes as “personal cell therapy” to use your own cells to start or enhance “your own healing process.” The site goes on to promise “you will lead a life that is more meaningful and pain-free with services that will change your life and lifestyle.”
It lists what it claims is scientific literature suggesting “these cells may represent a medical breakthrough in the treatment of many chronic medical conditions.”
Patients would pay $3,995 or more for a stem cell procedure, according to the lawsuit. Many people thought they were part of a patient-funded research study, and regulators accused the clinic of giving patients the false impression that the treatments were part of a study approved by the F.D.A.
The clinic emphasized its research, including a long list of “reference articles and studies,” according to the lawsuit. “Such claims overstate the scientific legitimacy” of the clinic’s treatments, the regulators said.
Regulators also say Dr. Singer is operating a GoFundMe fund-raising campaign to perform stem cell treatments for free. “Not only chronic pain, but other ailments such as post traumatic brain syndrome, autoimmune diseases, orthopedic injuries and other ailments can be helped by this amazing procedure,” the campaign promises. So far, Dr. Singer appears not to have raised any money.
Since being contacted by state regulators, the clinic has revised its website and added numerous disclaimers, but state officials say consumers had a “net impression” that stem cells were an effective treatment for these various conditions. The website also appears to have been further changed to solely emphasize orthopedic conditions like arthritis or joint disease.
