FDA in the Works to Halt Experimental Stem Cell Therapy That Blinded Patients

U.S. Stem Cell accumulated $6.7 million in revenue in 2018, overseeing three clinics and doctors who were trained at 150 other locations. It is known as the chief stem cell treatment provider in the country, yet the Food and Drug Administration is taking action to stop its management until further notice. Several reports of serious injury and irreversible harm have been documented against the stem cell company according to Washington Post reporters Laurie McGinley and William Wan.

The case began during the summer of 2015 when ophthalmologist Dr. Thomas Albini had a 78-year-old female patient with macular degeneration come in to the office complaining of a sudden loss in vision in both of her eyes; she had been receiving a new treatment of stem cell injections made from the fat in her belly administered by U.S. Stem Cell in a Miami clinic, giving her false hope that it would treat her disease. Upon examination, Dr. Albini noticed hemorrhaging in the patient’s eyes and a substantial drop in her vision.

Dr. Albini saw another patient the next day in the emergency room at the University of Miami reporting blindness and sharp pain after receiving injections from the same establishment, U.S. Stell Cell. Dr. Albini reported both patient cases to the FDA to begin an immediate investigation.

The FDA is charging the company for its illegal treatments and taking them to federal courts in Fort Lauderdale, Florida, in what is known as one of the government’s most hostile conflicts against the stem cell business for “openly violating the law and endangering patients.”  However, the FDA has not been responding quickly enough to halt the false treatments that have been taking place which has allowed U.S. Stem Cell to continue operating for nearly four years to date. It has been reported that the company has ceased the injections from fat-transferring methods (as the patients had filed lawsuits), although it continues selling stem cell therapy to people with spine issues, Parkinson’s disease, multiple sclerosis and other chronic diseases. 

During spring of 2018, following three weeks after the government had filed a lawsuit against U.S. Stem Cell, a 59-year-old woman felt dizzy and began vomiting two hours after receiving stem cell injections for her arthritic pain at a South Miami clinic. She was transported to a hospital and succumbed to a coma for more than one month. Dr. Albini argues that “it’s frustrating [to see the] clinics are still operating, and surprising that authorities aren’t moving faster—even now.”

The FDA is suing the stem cell company for the one procedure that was reported by the first two patients of Dr. Albini, a stem cell therapy derived from fat cells in the patient’s body. The method is described as removing the fat from the patient’s stomach area, mixing the contents with an enzyme to decompose the tissue and centrifuge the mixture to separate mesenchymal stem cells—known to adapt into different types of cells. Those isolated cells are then injected into the patient to treat their existing condition. 

The FDA has been notified several times by scientists over the past few years to examine what is happening in the clinics where the U.S. Stem Cell treatments are being ordered. During this entire time, the company continues to work under the same conditions, possibly modifying some procedures such as the eye injection to steer clear from any further blindness. To date, four patients have become blind from these procedures and one woman, noted above, who went into a coma for one month.

McGinley and Wan have investigated the cases of all five patients and reported that more than years after the first notice Dr. Albini sent, the FDA eventually send a warning letter to U.S. Stem Cell affirming their knowledge of what illegal activity is taking place in the clinics. FDA commissioner Scott Gottlieb  noted that when he consulted officials who regulate stem cell clinics, that they gave word that they would make this issue one of their top priorities—indicating that no sudden change would take place in the near future.

In 2017, the FDA sent its first warning in the form of a letter to the company, filing a suit for selling an unapproved treatment that is falsely labeled as medicinal, taking no responsibility for their patient’s detrimental repercussions. U.S. Stem Cell took action and called the accusations “blatantly false” following the warning letter sent by the FDA in 2017, and hired a competitive law firm in 2018 that will defend the company. It has also been gathered that the company has made alliances with people who have association with President Trump.

An extensive interview also took place with the company’s chief scientific officer Kristin Comella at the main operating clinic in Weston, Florida, where Comella stated that the FDA is violating the rights of the company and not taking into account the successful treatments that the company has monitored to more than 10,000 patients.

The FDA mentioned that the warning to U.S. Stem Cell included an “enforcement discretion” period, giving the company three years to adapt to the safety rules. So far, the FDA reports that it has seen small progress, but perhaps more changes will take place by 2019 or 2020.