New York Attorney General Letitia James announced on Thursday, April 4, 2019, that her office has filed a lawsuit against Park Avenue Stem Cell, accusing the for-profit stem cell clinic of performing unproven procedures on patients with wide-ranging medical conditions. The lawsuit is one aspect of Attorney General James' crackdown on stem cell clinics in New York, which often promise miraculous results despite insufficient scientific evidence.
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The FDA is also struggling to keep up with growth in the stem cell industry, taking on rogue clinics across the country offering unproven treatments. In early April, the agency warned two dozen clinics nationwide to stop offering treatments that may harm patients.
The FDA says that many clinics and stem cell manufacturers offer therapies to treat medical conditions from erectile dysfunction and sore knees to heart disease without any proof that the treatments are safe or effective.
Some of the stem cell treatments have already proven dangerous, and critics of the industry blame a lack of regulation. At a Florida stem cell clinic, three women were blinded after stem cells were injected into their eyes. And in California, twelve patients were hospitalized with severe infections after being injected with stem cells derived from umbilical cord blood.
In Midtown Manhattan, Park Avenue Stem Cell, the company currently under scrutiny, claims that "current literature in the scientific community suggests that treatment with these cells represent a medical breakthrough in the treatment of many chronic medical conditions." The clinic's website claims it offers "personal cell therapy" to "enhance the healing process in your own body." But regulators say these claims have yet to be proven, at least when applied to the specific treatments offered by Park Avenue Stem Cell.
Park Avenue Stem Cell is run by Dr. Joel B. Singer, a plastic surgeon. In 2007, Singer was sanctioned by medical regulators in Connecticut and New York over allegations of negligence, incompetence and inaccurate record keeping. He was fined $5,000. Dr. Singer is also reportedly operating a GoFundMe campaign in hopes of offering stem cell treatments at no charge. The campaign promises, "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." No one has yet donated to the campaign.
Regulators also say Park Avenue Stem Cell was part of the Cell Surgical Network, a business based in California with around 100 affiliate clinics across the country. In May 2018, the Food and Drug Administration filed suit against the Cell Surgical Network and affiliate clinics for administering a stem cell product derived using the smallpox vaccine to cancer patients. Regulators say the treatment posed a risk of heart inflammation.
Stem cells are derived from cells found in the blood, fat or birth tissues, and doctors are excited about the possibilities of these treatments. But health regulators, both on the state and federal level, have become increasingly concerned that the medical claims made by companies and clinics providing stem cell treatments are not in line with available medical evidence. Many of these clinics, Park Avenue Stem Cell included, offer people treatments that can cost thousands of dollars. In most cases, patients pay for the therapies out of pocket, because health insurers refuse to cover the services.
In recent years, hundreds of stem cell clinics have popped up across the country. Offering treatments containing stem cells, which have the potential to grow into other cell types, the clinics promise effective therapies for a wide range of severe medical disorders, but scientists say there is no proof that they are effective or safe.
Park Avenue Stem Cell focused on treatments using cells taken from a patient's own adipose, or fat, tissue. Clinics offering similar treatments often argue that, since the stem cells are derived from a patient's own tissues, they should not be considered a drug and regulated as such by the FDA. According to the New York lawsuit, "defendants claims 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 though there is currently no adequate scientific substantiation that these treatments will be effective; in fact, they could be harmful."
"Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful and immoral," James said in a press 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."