Jun 10, 2019

FDA Rules Against For-Profit Stem Cell Company

Quick on the heels of last week’s Washington Post article discussing the dangers of stem cell therapy, a U.S. federal judge ruled in favour of the Food and Drug Administration (FDA) in a lawsuit against U.S. Stem Cell, a for-profit stem cell company.

The ruling, which was passed down in Florida, gives the FDA the authority to regulate procedures that use a patient’s fat cells to create a stem cell treatment – treatments that for-profit companies erroneously claim can “cure” diseases like Parkinson’s disease, multiple sclerosis, and different forms of blindness.

These so-called “treatments” are dangerous not only because they abuse the trust of people desperate for cures, but also because they put patients’ heath at risk. In several cases, people went blind after receiving stem cell injections to treat age-related macular degeneration.

The ruling marks an important evolution in the stem cell industry and is a victory for the future of legitimate stem cell therapies. By cracking down on unregulated and unapproved direct-to-consumer marketed stem cell treatments, the FDA is standing up for patient safety.

While this is a step in the right direction, it doesn’t prevent other for-profit companies like U.S. Stem Cell from operating. That’s why Fighting Blindness Canada wants to ensure that people in the vision loss community know the facts.

Stem cell therapy is a promising research field, but there are no proven stem cell treatments for vision loss. At FBC, we are always looking into the best and most promising research into blinding eye diseases, but there are no stem cell treatments that have received approval from the FDA or Health Canada. All potential medical treatments must undergo the clinical trial process, which ensures that the research meets high patient safety standards. Clinics that claim to be able to “cure” diseases through stem cell treatments have not undergone the clinical trial phase and are not safe.

Clinics that ask you to pay for treatments or trials do not have your best interests at heart. Several of these unscrupulous stem cell clinics tell patients that they are participating in a “clinical trial” and ask patients to pay to participate. As clinical trials are scientific studies – not treatments – legitimate hospitals and academic institutions will never ask people to pay. As Dr. Mary Sunderland, FBC’s Director of Research and Education, said in a recent podcast: “If you’re being asked to pay for a treatment or to participate in a clinical trial, run in the opposite direction.”

You can learn about the most promising stem cell research by watching this recent talk by Dr. David Gamm, who receives funding from Fighting Blindness Canada. Dr. Gamm’s research aims to develop a new stem-cell transplantation therapy to restore vision.