• Lawsuit: Georgia doctors blind woman with unproven stem cell procedure

    By: Jim Strickland

    Updated:

    ATLANTA - Doris Tyler’s eyesight was fading. Her sheet music was hard to read, and baseball games were foggy. A friend gave her a book called "The Stem Cell Revolution", and doctors told Tyler the worst that could happen was the treatment wouldn't work.

    She gave it a try anyway. Within weeks she was completely blind. 

    “I'm not stupid,” Tyler told Channel 2 Consumer Investigator Jim Strickland. “I would not have taken that chance if I had known that there was any risk of going blind.”

    Federal regulators claimed in court documents the doctors who performed Tyler's procedure are affiliated with a network of clinics making deceptive and even dangerous claims about stem cell treatments.

    “This was going to be the most wonderful thing that ever happened to me,” said Tyler, who is now suing the doctors who did her procedure, and the California doctors behind the network they’re affiliated with.

    Doris told Strickland not seeing her grandchildren grow up brings her the most pain. Her husband Don is her full-time caregiver and they spend most days in their Ocoee Florida home.

     

    “To go somewhere, and me enjoy it, she has to be involved,” Don Tyler told Strickland. “She can’t see, so why go?”

     

    Doris was diagnosed with macular degeneration nearly a decade ago. MD is an incurable eye disease that affects more than 10 million Americans. The affected person’s retina deteriorates over time, and slowly robs them of their vision. Doris’ vision was failing, but she was functioning. Although she could not drive a car, Doris still enjoyed traveling and lived an independent life. 

     

    "The Stem Cell Revolution" was authored by California doctors Elliot Lander and Mark Berman. They’re Stem Cell Network offers treatments for about two dozen ailments, from hair loss to lung disease.  The network’s affiliates across the U.S. including Dr. Jamie Walraven’s Stem Cell Center of Georgia located in Peachtree City.

     

    In September of 2016 Walraven performed liposuction on Doris and made a stem cell cocktail from her fat tissue she called “liquid gold” on a recording of the procedure. Later an eye surgeon injected the stem cells in to Doris’ eyes. By early December she was completely blind. She later learned she was the clinic’s first MD patient. 

     

    Doris suffered retinal detachments after her stem cell injections. A 2017 study published in the New England Journal of Medicine, studied other patients who experienced partial or full blindness soon after similar stem cell procedures. The paper stated, “although numerous stem-cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy.

     

    “I’ve been called into four separate cases where women have been blinded from the exact same procedure that Doris experienced,” said Andrew Yaffa, who is representing the Tyler’s in their lawsuit against the doctors. 

     

    The Department of Justice also filed suit against the Stem Cell Network that stated, "an injunction is necessary to prevent defendants from experimenting on patients with adulterated and misbranded drugs."

     

    Former Food and Drug Administration attorney Patti Zettler said there has been some debate over the policing of stem cell interventions. She said since 2017 the FDA increased its oversight over stem cells and gave doctors offering stem cell treatments three years to provide clinical proof their treatments are safe and effective. FDA has the authority to take immediate action if a patient’s safety is at risk.
     

    Zettler cautioned the late enforcement may create challenges for federal regulators. “Once products are out there, once interventions are out there being provided to patents it is more difficult to rein in the business to rein in that practice,” she said. 

     

    According to a consumer warning released by FDA in 2017 the only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells from umbilical cords.

     

    Researchers at the Regenerative Bioscience Center at the University of Georgia are currently testing umbilical cord stem cells for diseases like Alzheimer’s and Parkinson’s. It takes years in a lab to test a treatment's effectiveness, then years of clinical trials in animals and humans to guarantee safety. 

     

     “The [stem cell] claims that are out there, without those clinical trials are just claims, and nothing more than that,” said Regenerative Bioscience Center Director Steve Stice. “The ability for stem cells to treat a number of diseases, it’s here, it’s being used, it’s just that we of course need to be diligent in how we test them and make sure that they’re safe and effective."
     

    Stice said clinical trials exists only for a handful of stem cell treatments, like childhood leukemia. Yet a study in 2016 (LINK) mapped out hundreds of stem cell clinics and called Atlanta a hot market. The Tyler's attorney Yaffa has counted 750 in operation. 

     

    Walraven’s attorney declined to comment on the Tyler’s lawsuit. When Strickland asked Walraven outside of her Peachtree City clinic if she had proof that stem cells can treat MD she said she could not comment on an ongoing investigation. When asked if she had any apologies the Walraven said, “I am so sorry for what has happened to people that don't get the results that they want.”   

     

    “These clinics across the board are engaging in human experimentation,” Yaffa said. “This isn’t right, it’s not legal, and it needs to stop.”
     

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