A South Florida clinic where three women were blinded after receiving stem cell injections in their eyes in 2015 was barred from using the experimental therapies on patients after a U.S. District Court judge ruled on Tuesday that the treatments must comply with federal drug safety regulations.
The judge’s ruling for a permanent injunction against Sunrise-based US Stem Cell and US Stem Cell Clinic follows nearly two years of efforts by the Food and Drug Administration and the Justice Department to warn patients about the risks of the experimental therapies amid the rapid growth of direct-to-consumer stem cell clinics in Florida, California, Texas and elsewhere.
US Stem Cell, which has clinics in Weston, West Palm Beach and the Villages, markets stem cell therapies derived from a patient’s fat as viable treatments for Parkinson’s disease, spinal cord injury, heat disease, stroke, arthritis and other medical conditions without approval from the FDA or scientific proof of their efficacy, according to a complaint filed by the Justice Department in 2018.
In a written statement, FDA leaders, including Ned Sharpless, acting commissioner of food and drugs, and Peter Marks, director of the Center for Biologics Evaluation and Research, said Tuesday’s ruling should send a message to the hundreds of stem cell clinics that have opened since 2009 and promise to heal a variety of serious medical conditions.
“There are many examples of companies deceiving patients with unsubstantiated claims about the potential for stem cell products to prevent, treat or cure serious diseases, and in those cases, we are committed to acting to protect patients,” the statement read.
Kristin Comella, the chief scientific officer for US Stem Cell and a defendant in the Justice Department’s lawsuit, did not return a message left with a woman who answered Comella’s cellphone on Wednesday.
In defending against the Justice Department’s lawsuit, the company had argued that the stem cell therapies were not subject to FDA drug regulations because the products were “stromal vascular fraction,” or SVF, meaning the stem cells were derived from fat taken from the patient’s bodies.
Fat tissue removed from patients was treated to isolate stem cells and then delivered back into their bodies — a process the clinic’s operators considered a medical procedure and not a drug.
In a written statement, US Stem Cell cast the judge’s ruling in a favorable light.
“We’re pleased to see the judge agreed with our position limiting the injunction only to the SVF procedure,” the statement read. “We are considering our legal options as to the court’s ruling on the procedure.”
The clinic had already stopped performing the procedure on patients’ eyes.
District Judge Ursula Ungaro found that the stem cell products were drugs subject to federal regulation under the Food, Drug and Cosmetic Act, which gives the FDA authority to oversee the safety of food, drugs, medical devices and cosmetics.
Stem cells are the foundation cells for every organ and tissue in the human body. They can regenerate and produce more stem cells of the same kind, and they can mature or ‘differentiate’ into specialized cells that carry out a specific function, such as in the skin, muscle, or blood.
While research shows that stem cells have the potential for medical treatments, and the FDA notes that legitimate therapies are in development to treat certain cancers, heart disease and other conditions, scientists still have much to discover about how stem cells work and their ability to heal.
But some clinics have been accused of taking advantage of patients by exploiting a widespread belief in the eventual promise of stem cells. In the past year, the FDA has sent warning letters and regulatory notices to at least 46 manufacturers and others promoting stem cell therapies.
A study published this week in the Journal of the American Medical Association found that despite federal crackdowns, more than 700 clinics in the United States advertise unproven treatments. The JAMA study found that many clinics are staffed by clinicians who provide stem cell therapies for conditions outside their area of medical expertise.
In its complaint against US Stem Cell, the Justice Department alleged that the clinic and its affiliates used unapproved and unlicensed stem cell therapies on thousands of patients, in some cases causing serious harm.
When three women with a common age-related eye disease were blinded after receiving stem cell injections at US Stem Cell in summer 2015, an ophthalmologist at the University of Miami Health System’s Bascom Palmer Eye Institute who helped care for the women co-authored an article about their experience in the New England Journal of Medicine.
The article exposed weaknesses in the U.S. government’s oversight of unproven treatments involving stem cells. It also raised questions about whether federal regulators are doing enough to protect patients from risky medical procedures — especially ones that project the false impression that they are government approved.
The three women, ages 72, 78 and 88, all had macular degeneration, a common eye disease among older people that can lead to vision loss. They paid $5,000 each for the procedure.
The article noted that the women may have been misled into thinking that they were participating in a legitimate clinical trial sanctioned by the National Institutes of Health, part of the U.S. Department of Health and Human Services, because at least two of the women said they learned about the stem cell procedure through the website ClinicalTrials.gov — an NIH database that lists publicly and privately supported clinical studies conducted around the world.
Months after the article was published in March 2017, FDA agents inspected US Stem Cell and issued a warning letter to the clinic citing violations of federal standards for drug safety and manufacturing. That year, the FDA also announced a comprehensive policy framework for the development and oversight of stem cell therapies.
Bernard Siegel, an attorney and a founder of the World Stem Cell Congress, an annual conference on regenerative medicine that attracts scientists and physicians working in the field, said the proliferation of unlicensed clinics promising too-good-to-be-true treatments is undermining legitimate research in the field.
“What has emerged is a global cottage industry of clinics that are touting stem cells as a cure-all,” he said during a conference in Miami in January 2018. “That has put a tremendous burden on legitimate research and clinicians who want to incorporate regenerative medicine and cell-based therapy into medical practice.”
Though many stem cell clinics have been accused of providing false hope to vulnerable patients, there have been cases where stem cell therapies have helped improve medical conditions. The International Society for Stem Cell Research, a nonprofit group that advocates for research in regenerative medicine, publishes a handbook on stem cell therapies as a guide for patients considering stem cell therapies.
This article has been updated to include a statement from US Stem Cell Clinic.