FDA Wins Major Lawsuit Against Shady Stem Cell “Therapy” Company, U.S. Stem Cell

According to a publication from The Portland Press Herald, Judge Ursula Ungaro, a senior District Judge in the Southern District of Flordia, recently ruled in favor of the United States’ Food and Drug Administration in a lawsuit between the federal agency and the Florida-based stem cell “therapy” company U.S. Stem Cell — whose methods have left four blind.

About Stem Cell Therapy

It’s important to note, especially to any who would attempt use this story as a detractor of proven science, that stem cell therapy is used safely and effectively every year by trained medical professionals to achieve amazing results for a number of conditions.

Stem cell treatments have been used to treat patients with HIV, leukemia, and lymphoma. In fact, stem cell therapy has started to become a victim of its own success.

The media frenzy surrounding stem cells, on top of the occasional impressive headline, has attracted some of the less scrupulous elements of the American “medical” society.

U.S. Stem Cell – A Model Sham Stem Cell Clinic

Media attention and years of lax enforcement policy has allowed for an explosion in unregulated stem cell clinics that often offer low-quality, even dangerous “treatments” in countries across the world — including the United States. For the past two years, the Food and Drug Administration has expanded its efforts cracking down on the clinics that operate in a legal grey area. In April, the federal agency wrote advisory letters to as many as 20 stem cell clinics operating in the United States, warning them that their procedures may be unauthorized and non-compliant with federal regulations.

However, some companies are more obstinate than others — and it isn’t hard to see why. Last year, the United States Department of Justice began proceedings to sue U.S. Stem Cell, one of the earliest and largest of these shady clinics. U.S. Stem Cell brought in $6.7 million in revenue in 2018, just three years after four women went blind after receiving supposedly safe stem cell injections in their eyes. One woman, 78 years old, went in for injections when she showed symptoms of macular degeneration. Not long after, she was completely blind.

Three other women later reported similar symptoms after receiving mesenchymal stem cell injections, derived from their own fat tissues, in their eyes. An ophthalmologist noted that one of the women had blood clots forming in her eyes.

Kristin Comella, U.S. Stem Cell’s chief scientific officer, noted that the company no longer offers eye treatments. They do, however, continue to operate on some 5 to 20 patients every week. To the New York Times, Comella stated that “It is [her] life’s work to pioneer regenerative medicine and educate the public about its healing potential.” Despite acting as neither a genuine pioneer or educator in the field, Comella seems to stand by her claims. “I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body,” she continued.

Fomer Commissioner of the Food and Drug Administration Scott Gottlieb disagreed, noting that the recent ruling against U.S. Stem Cell was a “must-win” case for the FDA that “establishes the agency’s ability to regulate in this space.”


Do you think it’s important that the federal government be able to enforce strict standards of patient safety? Do you think U.S. Stem Cell was acting appropriately as a “healthcare provider”? Share your thoughts with Patient Worthy!

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