The complaints involve cells taken from patients’ own fat tissue to treat diseases – a practice that the FDA has not yet approved.
Federal prosecutors in California and Florida sued on Wednesday to stop two companies from providing stem cell treatments.
The suits allege that the clinics marketed their procedures as remedies for ailments including cancer and heart disease without proof of safety and efficacy.
Businesses put consumers at risk by promising benefits from treatments and products never approved by the Food and Drug Administration, the Justice Department claimed in court filings in both states.
Dr Mark Berman of the Cell Surgical Network is being sued over practices like this one, in which he collected fat from a patient’s back for an experimental stem cell procedure
A growing number of practitioners are undertaking procedures in which they collect the fluid from patients via liposuction, treat it with chemicals and then inject it back into the body to treat various conditions.
The lawsuits target Stem Cell Treatment Center, with two locations in Southern California, and U.S. Stem Cell Clinic of Sunrise, Florida.
Dr Mark Berman, co-director of the California clinics, said he stands by his treatments and looks forward to fighting the lawsuit. He said the government had outdated views of stem cell research.
‘The idea that we’re doing something dangerous is erroneous,’ Dr Berman said.
US Stem Cell said in a statement that it would ‘vigorously’ defend itself in court.
‘I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body,’ said Dr Kristin Comella, the Florida company’s chief science officer.
According to the complaints, the defendants used their products on thousands of patients without first obtaining necessary FDA approvals.
The clinics claim the procedures can treat ailments including cancer, pulmonary disease, arthritis, stroke, Parkinson’s disease, spinal cord injuries and traumatic brain injury.
The court filings allege that that in some cases patients suffered ‘adverse events’ including infections that required hospitalization and, in at least one instance, retinal detachments after receiving eye injections.
The suits were filed at the request of the FDA, officials said.
Last year the FDA laid out a strategy for regulating cell-based medicine, including the practices of hundreds of private clinics that have opened across the nation in the last decade.
But only a handful of stem cell treatments currently have the FDA’s blessing, including those using cells taken from bone marrow to treat related cancers and those from cord blood to treat blood disorders.
Dr Mark Berman, of the Cell Surgical Network, injects a patient with a solution he says is rich in adult stem cells, but the FDA alleges that his practice violates its regulations
Stem cell treatments are problematic for the FDA because they neither fall into the categories of ‘drugs’ nor ‘medical devices’ that the agency regulates.
Though they show promise for treating everything from cancer to signs of aging, these treatments remain in regulatory limbo.
Yet businesses like Stem Cell Treatment Center are forging ahead with treatments – and profits – in spite of FDA warnings.
Many of these businesses promote stem cell injections for dozens of diseases. They can cost $5,000 to $50,000, but there’s little research that such procedures are safe or effective.
Stem cells have long been recognized for their ability to reproduce and regenerate tissue.
While emerging research suggests that they will eventually be used to treat a range of debilitating diseases, they are currently only approved for a handful of medical procedures.
For instance, adult stem cells from bone marrow transplants have long been used to treat leukemia and other blood diseases.