A Kansas City woman says she suffered a severe infection after receiving an unapproved stem cell treatment at a chiropractic clinic in south Overland Park.
Michelle Twyman was hospitalized after receiving injections in both knees in 2017 at Peak Health, according to a lawsuit filed last month. The suit alleges she was harmed by tainted umbilical cord products sold by Liveyon, a Nevada-based stem cell distributor.
Liveyon’s ReGen series of products were recalled last year after the Food and Drug Administration and the Centers for Disease Control found that some were contaminated with germs like E. coli, a bacterium found in feces.
Twyman’s suit faults Peak Health chiropractor Troy Albright, nurse practitioner Brooke M. Jones, who performed the injections, and physician Angela Garner, who supervised Jones.
“The Regen 30 product was never fit for use in treating joint pain and had not been shown to be effective for this use, a fact that was known or should have been known by each defendant,” the suit says. “However, (the) defendants each played a part in convincing (Twyman) that this product was safe and effective.”
Albright and Jones didn’t respond to messages left Friday morning.
Albright’s lawyer, Andrew Nantz, provided another court filing in the suit in which Albright faults Liveyon and its supplier, Genetech, for the contamination. It says that Albright himself received injections and also suffered several infections.
As of Friday morning, though, Peak Health was still advertising unapproved stem cell treatments with Liveyon products on its website.
“I can tell you for certain they are not providing stem cell treatments,” Nantz said. “That’s an oversight on their part.”
Nantz later said Peak Health is still doing stem cell treatments but has a new supplier.
The CDC linked a dozen infections to Liveyon’s Regen products last year, leading to a spate of lawsuits in other states. Liveyon has blamed the contamination on a supplier, Genetech, which is also a defendant in Twyman’s suit.
Twyman’s suit was filed in Miami County, Kansas, where Albright lives. Twyman’s attorney, Scott Bethune, emailed the complaint to The Star after reading its recent investigative report on stem cell clinics.
According to the complaint, Twyman’s left knee was infected with E. coli and one other type of bacteria after the injections. The infection allegedly worsened her pre-existing medical conditions and caused new damage. She also continues to incur medical bills and has lost wages because of it.
Peak Health is one of at least a half-dozen clinics in the Kansas City area advertising stem cell treatments for a variety of unapproved uses — part of a national trend that has vexed FDA officials for years.
Stem cells are the building blocks of human tissue — they’re what becomes the skin, muscle, bone or other cells that make up our bodies. Experts believe they hold promise for treating disease, but caution that much more research is needed in most cases. Right now they’re only FDA approved for a few blood conditions.
Still, clinics across the country have been harvesting cells from patients’ fat or bone marrow, or buying umbilical cord products from tissue distributors like Liveyon, and then charging thousands of dollars to inject them into patients.
In addition to doubts about whether those treatments actually do anything or they just produce a placebo effect, some have harmed people.
So far, the FDA has taken legal action against a few particularly bad actors, while issuing an escalating series of warnings to the rest of the industry.
The agency got an injunction in June against a Florida clinic accused of blinding several people — including retired University of Missouri-Kansas City professor Elizabeth Noble — with stem cell eye injections. In 2017 federal agents raided the California lab of a doctor who was combining stem cells with live smallpox vaccine, a restricted substance, and injecting the concoction into cancer patients.
But by some estimates there are still about 1,000 clinics nationwide offering unapproved stem cell treatments for everything from joint pain to multiple sclerosis to erectile dysfunction.
Garner now works at LifeWorks, a chiropractic clinic in Shawnee that also offers stem cell injections.
Matt Gianforte, a chiropractor with LifeWorks, said Garner was not available Friday but she “feels terrible about what happened” to Twyman. Gianforte said Garner and Peak Health followed all protocols and Liveyon was solely responsible for Twyman’s injuries.
“Dr. Garner has supervised clinics for over eight years with no negative reactions and helped hundreds reduce pain, without more opioid medications,” Gianforte said via email. “This is an isolated incident unrelated to the quality of care of so many patients.”
Last year Garner was temporarily barred by the Kansas medical board from working at any clinic offering vitamin IV infusions — another “wellness” treatment that medical experts say is unproven.
When Garner got her Kansas physician license in 2008, the medical board noted that her medical school, a Caribbean institution called the Saba University School of Medicine, was not accredited when she attended from 1998 to 2002. But the board approved her license anyway because she was licensed in Missouri and she had passed residency exams.