Businesses offering these therapies, which may cost thousands of dollars, evade federal regulations, says UB’s Laertis Ikonomou
By the University at Buffalo
Be wary of “stem cell” therapy as a preventative treatment for COVID-19, warns Laertis Ikonomou, University at Buffalo expert on stem cell and gene therapies.
While stem cell therapy, such as bone marrow transplantation, may be used to treat a limited number of diseases and conditions, there are currently no clinically tested or government-approved cell therapies available for the treatment or prevention of COVID-19, says Ikonomou.
He urges the public to exercise caution as the nation experiences a rise in businesses offering direct-to-consumer, unproven and unsafe “stem cell” therapies that promise to prevent COVID-19 by strengthening the immune system or improving overall health.
“What these patients are actually sold is false hope,” says Ikonomou, Ph.D., associate professor of oral biology in the UB School of Dental Medicine. “These businesses are continuously transforming and reinventing themselves, but the common thread is that they offer potentially dangerous treatments based on unproven science.”
Ikonomou is also the chair of the International Society for Cell and Gene Therapy (ISCT) presidential task force on the use of unproven and/or unethical cell and gene therapy.
Operating in ‘Shadows of the Law’
Stem cell therapy involves the conversion of stem cells into specific types of cells, such as heart or blood cells. These cells are then transplanted into a patient to promote healing.
While there are companies that carefully develop cell-based treatments following established regulatory and ethical standards, there has also been an explosion of businesses since the mid-2000s that advertise directly to consumers and evade regulations to provide unsafe and ineffective treatments, Ikonomou says.
These businesses operate in gray regulatory areas, frequently branding “stem cell” therapies as medical interventions rather than therapeutic drugs to avoid the need for U.S. Food and Drug Administration (FDA) approval, he says.
According to published research, there are more than 1,000 of these unsafe businesses in the U.S., Ikonomou notes. They offer purported “stem cell” therapies for nearly every condition imaginable, from diabetes and autism to Alzheimer's disease. There are also reports of people suffering physical harm – including blindness and death – from unsafe “stem cell” interventions, such as drawing and reinjecting patients with their own fat cells, he says.
“I’m not surprised that a lot of these businesses went into COVID treatments,” Ikonomou says. “They went where the money is and took advantage of people’s fears.”
The treatments range in price from a few thousand to tens of thousands of dollars, and often patients are encouraged to receive the expensive infusions every few months. Many people go into severe debt to acquire these ineffective treatments, he says.
This year, the FDA has issued several letters to offending businesses, including those advertising cell therapies for COVID-19, Ikonomou says. The Federal Trade Commission has also cracked down on misleading advertising from “stem cell” therapy clinics, he adds.
However, many of these clinics are small and difficult to track. Patient prudence is key to avoiding harmful interventions, he says.
Spotting Red Flags
Ikonomou shares a list of steps the public can take to ensure a stem cell therapy is safe, proven and ethical.
√ Avoid clinics that treat many conditions with the same cell product.
√ Walk away from websites that feature too many patient testimonials. It’s unknown when and from whom endorsements were taken.
√ Check with your insurance provider to ensure an offered therapy is covered. Insurance companies won’t cover unproven or experimental treatments.
√ Verify that clinical trials are under FDA oversight. Look for an “Investigational New Drug” (IND) application number.
√ Patients do not typically have to pay to take part in clinical trials. Be cautious of trials that ask the patient to pay exorbitant amounts for treatments.
Ikonomou also urges patients to share any questions they have with their physicians, who often are the gatekeepers for medical treatment. His best advice to patients is, “If something sounds too good to be true, it probably isn’t true.”
For information on safe and ethical cell therapies, visit the ISCT website.
The views and opinions expressed in this commentary are based on the opinions and/or research of the faculty member(s) or researcher(s) quoted, and do not represent the official positions of the University at Buffalo, or Niagara Frontier Publications.