番茄社区

The Washington state attorney general for deceptively marketing its products to treat COVID-19 and a host of other conditions despite a lack of evidence.

Since 2018, Seattle-based US Stemology and owner Tami Meraglia, MD, allegedly charged 107 people nearly $750,000 in total for stem cell treatments for various conditions without evidence they worked, according to filed by Washington state Attorney General Bob Ferguson.

Ferguson also alleged that the company claimed it was treating patients as part of a clinical trial, but the private institutional review board (IRB) tapped for oversight had significant conflicts of interest.

"Instead of performing legitimate clinical research, US Stemology used a biased, self-interested IRB to mislead patients to believe that they were participating in 'clinical research' -- when they were, in reality, paying to receive unproven medical treatments," the attorney general's press release stated.

For some of its procedures, Meraglia's clinic used adipose-derived mesenchymal stromal cells (AD-MSC), according to the complaint. In this procedure, cells are harvested from a patient's own fat tissue in a manner similar to liposuction, then turned into "stromal vascular fraction" and injected back into the patient.

The clinic also used lab-made stem cell products known as exosomes and cord cells, the complaint alleged. Exosome products were purchased from Kimera Labs in Miramar, Florida, while cord cell products were bought from FIOR Bioscience in Sandy, Utah. 番茄社区 has reported that Medicare has started clawing back payments made to doctors for these products.

Meraglia's clinic charged $9,000 for a single AD-MSC treatment or $13,500 for a package of three treatments, according to the complaint. It charged $5,000 for exosome or cord cell treatments, and $2,200 to add an exosome or cord cell treatment to the AD-MSC procedure.

Ferguson's complaint alleged that Meraglia launched the stem cell clinic out of the basement of the "medispa" she owned, which had mainly offered aesthetic and cosmetic treatments prior to stem cell therapies. She advertised these stem cell therapies for a host of conditions, including asthma, lupus, Parkinson's disease, congestive heart failure, and multiple sclerosis.

However, there is no solid evidence that these treatments work in any of these conditions, and the FDA now requires clinics and stem cell manufacturers to comply with its requirements for regenerative medicine products.

According to the complaint, Meraglia and her clinic did not file an IND application with the FDA. The company's clinical trials were done under the supervision of an IRB operated by the International Cell Surgical Society (ICSS), a tax-exempt organization located in Palm Desert, California.

Two of the primary researchers listed on the US Stemology trials were also principal officers of ICSS when it approved the trials, which Ferguson's press release called a "clear conflict of interest."

Those physicians are Elliot Lander, MD, and Mark Berman, MD, who operate the California Stem Cell Treatment Center in Rancho Mirage, California. Lander and Berman are also founders of Cell Surgical Network, a group of stem cell treatment providers across the U.S.

Ferguson's complaint also alleges that the trials had no control group, no standard course of treatment for each patient, and relied solely on patient surveys to assess results.

The attorney general's office was first alerted to the clinic's questionable practices by a citizen who reported the company's false claims that it could treat and prevent COVID-19 with stem cell products. Ferguson alleged the company made these claims for at least 3 months during the early stages of the pandemic.

Authorities conducted an investigation of the clinic, and US Stemology stopped taking new stem cell patients in June 2021, according to the press release.

Ferguson maintains that US Stemology and Meraglia violated the Washington Consumer Protection Act by deceptively marketing stem cell treatments for serious conditions without scientific evidence.

Comment