Doris Tyler lay on the exam table when the doctor put a long thin tube in her stomach. The doctor pulled back a butt, and the syringe filled up quickly with yellow, pink spots.
"Look at this beautiful fat that comes out – liquid gold!" Exclaimed one of the clinic staff in a video about the Washington Post procedure.
Hidden in this fat were stem cells with the amazing power to heal, the Georgia Stem Cell Center told Tyler. The clinic is one of hundreds that have surfaced across the country, many offering treatments for Parkinson's disease, autism and multiple sclerosis.
Federal regulators have not approved any of their treatments, and critics refer to such clinics as modern snake oilers. But on this day in 201
Five days after the injections, the clinic bragged online that she had performed the first such treatment in Georgia for macular degeneration. On Facebook, the clinic called Tyler "our fabulous patient!" And asked others with their illness to make an appointment.
But at that time, Tyler's vision blurred.
Within a few weeks, the retina dissolved in her left eye. Then the retina went into her right eye, according to a lawsuit filed by Tyler and her husband against the clinic in March. An operation after surgery could not repair the damage. She quickly lost the ability to read large text print. She could no longer recognize the faces of her seven grandchildren.
Within a few months, she said, she was completely blind.
"We trusted this person, and we never questioned that they knew what they were doing," Tyler said in her Florida home.
Doris Tyler in her living room in Ocoee, Florida, in February. (Zack Wittman for The Washington Post)
The Tylers lawsuit claims negligence on the clinic she treated, the network she belongs to, and an external ophthalmologist. The clinic's owner and employees and the ophthalmologist refused to answer repeated calls and e-mail questions. The co-founders of the clinic network said neither the clinic nor the facility in Georgia did anything wrong.
For years, such direct-to-consumer stem cell clinics have largely expanded unchallenged. However, cases such as Tylers have led to complaints and renewed efforts by state and federal agencies to stem potentially dangerous and worthless treatments.
Last year, California passed a law that stem cell hospitals accused of writing warnings about their treatments have not been approved, and the legislature of Washington passed a similar law this year. The Attorney General of North Dakota is examining a Bismarck clinic. And the Federation of State Medical Boards is looking for ways to improve the monitoring of clinics.
Interviewed by Commissioner for Food and Drug Control, Scott Gottlieb, and his predecessor, the Agency's limited resources alleged that no aggressive measures had been taken in the past. Since last summer Gottlieb promised to pursue "unscrupulous actors" who see the promising field of stem cell therapies endangered.
The agency, which in seven years issued only seven warnings to stem cell clinics and suppliers, has sent two such letters since August. It also ordered the seizure of an experimental batch of stem cells administered to cancer patients.
At the end of last year, officials clarified the previously bleak policy that many of the treatment clinics were unauthorized drugs, a crucial issue. The institutions argue that they are not subject to FDA regulation as they use surgical procedures to administer the patient's own cells – meaning that they are not producing new drugs.
But the agency insists that their therapies must be approved in advance because the cells they are used for treating diseases and for substantial processing before they are used differently than originally.
The FDA authorities are aware that curbing the entire booming industry is difficult in the brain, spinal cord and eye – rather than less risky, such as shots in painful joints.
This month, Senator Charles E. Grassley (R-Iowa) sent a letter to the FDA pleading for stronger action. Grassley cited the cases of three women who sustained permanent vision loss at a facility in Florida, the US Stem Cell Clinic. He asked what was done to make sure that such dangerous procedures were not repeated.
Clinic owners say desperately ill patients have the right to use their own cells for experimental therapies. They say their treatments have the ability to find and repair damaged tissues and organs, and they cite online testimonials from satisfied customers as evidence.
Regulators and researchers disagree to apply stringent regulations because clinics essentially perform human experiments without proper
"What they really sell is false hope," said Timothy Caulfield, a professor of health at the University of Alberta , "It's science – exploitation, they're taking a legitimate and developing field of science and using it to find patients who are desperately looking for a cure."
The treatments are not covered by insurance. Many patients in the clinic are old, sick and already have to deal with medical bills. Some clinics are demanding that people who can not afford their high fees – ranging from $ 1,800 to $ 20,000 – start or borrow GoFundMe sites, according to patients and former employees.
Many practitioners remain defiant and say patients need alternative treatments like theirs.
Mark Berman is a plastic surgeon in Beverly Hills, California, who co-founded Cell Surgical Network, the nation's largest group of independent stem cell clinics, including the facility that injected Tyler's eye material. After the network learned of its complications, Berman said it instructed all its affiliated doctors to stop such injections in the eye.
Berman said that Tyler's problem was "practically" the only serious adverse event in his network in the treatment of nearly 8,000 patients. But an FDA report in July 2017 listed four unwanted cases, including Tyler's. Berman said the others were "very insignificant" and cited the FDA's concern over patient safety as "hypocritical waste".
"How do you heal your body, you have to heal yourself," Berman said. He said it was "asinine" for the FDA to call a patient's own cells a drug.
For Tyler, however, the debate over the clinics came too late.
Before the injections, she was still able to read large print books and navigate home in Ocoee. But now she moves cautiously and clasps each piece of furniture like a life raft. Her husband has learned to cook for both of them, and Tyler – a former music teacher who is 77 – had to leave her church choir because she can no longer read the music.
"When I wake up in the morning, it's one of the hardest things to open my eyes and see that everything is still dark," she said recently. "And it will be so until I go to sleep."
However, what makes her most sad is that she will never see her youngest grandchildren grow up. In their mind's eye, they are frozen at the age of 1 and 3.
Researchers say the ability of stem cells to self-renew and transform into other cell types is really promising. They systematically develop stem cell therapies for many types of disorders, including macular degeneration, which can destroy the central vision of the eye. British researchers recently confirmed in a peer review report that two patients implanted with a manipulated stem cell patch regained vision
but such treatments – tested and refined in rigorous studies – were safely marketed will take years, say experts.
Few stem cell therapies have been approved by the FDA, primarily placental and umbilical cord blood products used to treat leukemia and other blood disorders.
How many people there are injuries have occurred from unproven, direct-to-consumer treatments. Such cases have only become public in recent years when physicians write about or complain about it in medical journals.
Two years ago, the New England Journal of Medicine published a report on a man who ended up with fetal stem cell injections overseas with tremendous growth of the spine. A 69-year-old woman died in 2010 after a doctor at a Florida clinic injected bone marrow stem cells into the arteries of her brain. In 2012, the same doctor infused fat-derived stem cells into the bloodstream of a man who died soon after, according to the results of an administrative hearing by the health department. But it was not until 2013 that Florida's state medical board revoked this medical license.
Tyler and her husband, Don, said their son created a GoFundMe site to charge $ 8,900 for their trial. (Zack Wittman for the Washington Post)
Financial damage is also a danger. Some clinics use high-pressure sales tactics that are more condominium-style than medical-typical – complete with recruiting seminars, on-site discounts, and emotional patient videos, such as patients and former employees who have attended such seminars. 19659042] Some clinics list their unapproved, paid procedures as "studies" ClinicalTrials.gov, a database maintained by the National Institutes of Health. Critics say that they use the database inappropriately to attract customers and add a touch of legitimacy to their treatments.
Most trials for new experimental therapies, unlike stem cell clinic procedures as part of the FDA's new drug program, are monitored free of charge for participants NIH does not independently validate the information or indicate whether a "study" listed in the database has been tested by the FDA. The website has recently added more visible disclaimers to warn consumers. Grassley expressed concern in his recent letter to regulators that the database is being abused.
A spokesman for the NIH said the agency "does not judge the quality of clinical research studies – this is the role of funders, regulators and ethics committees others."
"We fear that these charlatans have the reputation of legitimate work that we do have been sullying for decades, "said Charles Murry, director of the Institute of Stem Cells and Regenerative Medicine at the University of Washington.
Patients who say they benefit from the treatments in the stem cell clinics could experience the placebo effect or some biological improvement, Murry said. In conditions such as arthritis, these cells can talk to our immune system and say "cool it," resulting in temporary relief – like a weak steroid shot.
But if such treatments are not tested in rigorous trials, he said there is no way to know if they are safe and effective.
The first stem cell clinics emerged in the early 2000s in countries with loose regulations – such as China, Russia, and South Korea – and targeted desperate American "medical tourists." Soon followed by US doctors. For many, especially plastic surgeons, the suction of the fat tissue or fat of the patient was already routine.
Stem cell clinics have exploded in the United States. In 2009 there were two; According to Leigh Turner, a bioethicist from the University of Minnesota, and Paul Knoepfler, a stem cell biologist at the University of California at Davis, who has assembled a database today, there are at least 700 and probably hundreds more today. Over the last four years, at least 150 new facilities have opened each year.
The clinic that Tyler treated is located in a sleepy suburb 40 minutes outside of Atlanta. It is part of the Ageless Wellness Center, founded in 2008 by Jamie Walraven, a former emergency physician, and nurse Linda Faulkner.
For years, the two mainly offered Botox, laser hair removal and other beauty services. In 2014, they added their business model to stem cell treatments.
The Georgia Clinic says on its website that adult stem cells derived from fat are able to fix various defects and diseases throughout the body. In a promotional video for the clinic, patients say that injections have reduced their neck and knee pain and symptoms of multiple sclerosis.
Many researchers scoff at the idea that adult stem cells can circulate in the body and correct almost any problem. "This idea of a magic bullet that can go around filling gaps in the body is science fiction," said Sally Temple, co-founder of the Neural Stem Cell Institute in Rensselaer, New York. She said she doubts that there are any stem cells The processed material that most clinics inject into the patient.
In a local newspaper in June 2016, Walraven reported that her clinic used fat stem cells to treat multiple sclerosis, osteoarthritis, stroke, rheumatoid arthritis and Parkinson's disease. Over the next few weeks, she added, "We have an ophthalmologist who will treat three patients with macular degeneration."
Tyler was the first of these patients.
In spring 2016, when Tyler fought further with macular degeneration, a friend of the family gave her and her husband a book, "The Stem Cell Revolution." In it, plastic surgeon Berman and his partner, urologist Elliot Lander, report how their technique is developed in part by physicians in South Korea and Japan. They began treating patients in California and later launched the Cell Surgical Network, which includes more than 100 stem cell clinics nationwide, including the Ageless Wellness Center facility, which treats Tyler's eyes.
For a fee, Berman and Lander teach other physicians to do this to extract patients' fat through liposuction and process them with a proprietary centrifuge called "Time Machine." The machine and lessons cost about $ 30,000, they said.
"People license our brand, and what we give them is training and unlimited professional and technical support," said Lander. He said that affiliated clinics need to provide Cell Surgical Network with the results of their procedures so that they can track patients over time.
The two doctors say that the FDA is acting harder on behalf of the pharmaceutical industry,
Network website visitors scrolling down the homepage learn that "the treatment of stem cells is not FDA-sanctioned for certain Diseases is allowed. " When they click details, they are told that the clinics' therapies are not offered as a "cure for any condition, illness or injury."
But the Web site lists dozens of diseases, including congestive heart failure, muscular dystrophy and stroke, the Cell Surgical Network is currently studying. Patients will be charged for treatment fees – in what Berman calls "patient-funded research."
Walraven, in the Georgia Clinic, had never treated macular degeneration b ut it seemed eager to try, the Tylers said.
According to the lawsuit filed by the couple before a state court in Georgia, the clinic said the treatment would improve Doris Tyler's vision or, in the worst case, have no effect. The $ 8,900 fee was charged for her procedure, the Tyler's son a GoFundMe account that got an enthusiastic response. "We love you, Doris!", Wrote a person on the page. "If you need extra belly fat, I'm MORE than happy to offer mine!" Said another.
Walraven asked Robert Halpern, an ophthalmologist from Atlanta, to perform the injections. In a letter dated 30 June 2016, shared by Tyler's lawyer with the Washington Post, Walraven sent Halpern a booklet explaining how he could become a certified physician on the network.
Halpern injected Tyler's right eye on September 8, 2016 The next day, he injected her left eye, claims the lawsuit. To inject both eyes so close together is a safety hazard, say ophthalmologists, because if something goes wrong, patients can remain completely blind.
Thomas Albini, an ophthalmologist at the University of Miami's Bascom Palmer Eye Institute, treated Tyler after the stem cell procedure, but could not reverse the damage. Albini, who was detained as an expert in the Tylers lawsuit, said he believed that the processed fat injected into Tyler's eyes could contain fibroblasts – connective tissue cells that can cause scars and "literally" the retina from the wall of the eye In a process called proliferative vitreoretinopathy.
The Georgia Clinic, Walraven, Faulkner, and Halpern refused to answer repeated phone calls and mailed questions, and no one responded to the allegations in court
] Lander said all the clinics in the Cell Surgical Network use a "very, very thorough" consent form that expresses all risks, such as in Tyler's case, that their point of view is getting worse.
Tyler's lawyer, Andrew Yaffa, Said this was a "misrepresentation." He said she had received a letter of consent in which she said she was studying which was described as a research study. Other forms warned of possible complications from the injections, Yaffa said, but not from the stem cells themselves.
Andrew Yaffa, Tyler's attorney, helps guide her home. (Zack Wittman for The Washington Post)
Yaffa represented two women who achieved confidentiality after losing visions following a stem cell injection for macular degeneration at the US Stem Cell Clinic in South Florida, including in a New England Journal The doctor said that the Georgia clinic treating Tyler had "done the right thing," that a retinal specialist had the injections done, and that Cell Surgical Network stopped such eye injections as soon as he and Lander heard about Tyler's complications
but Ajay Kuriyan , a retinal specialist at the University of Rochester, said he and other researchers have found dozens of clinics that continue to market such eye drops on their websites. After writing this article about the three women who suffered severe eye damage at the Florida facility, Kuriyan said he and his co-authors had received a barrage of calls about other cases.
"The problem is still there," he said.
In August, the FDA sent a warning letter to the US Stem Cell Clinic; In January, another warning letter was sent to American CryoStem Corp. in New Jersey, which processes and sells a fat-derived stem cell product. Both companies, according to the agency, sold unauthorized medicines – including the US Stem Cell Clinic – for heart disease, amyotrophic lateral sclerosis and diabetes – and deviated from the right manufacturing practices.
What CryoStem responded to It would "actively work with the agency to solve these issues and further improve our quality systems and processes."
United States The Stem Cell Clinic told the FDA that it does not manufacture drugs and is not subject to regulatory regulation, and that patients have a right to alternative treatments. It denies that sterility problems occur during his surgery. In an interview, Chief Science Officer Kristin Comella said that the clinic is no longer performing eye injections and "the cases have been resolved."
Her goal, she added, is "to always help people achieve good health and make them feel good when they do not, it's personally devastating."
The company continues to expand. It recently opened another facility in a senior community in central Florida and announced plans to inject stem cell blends into patients' penises for the treatment of erectile dysfunction – a $ 4 billion market, a press release said.
Also, the FDA had last summer US Marshals resort to a vaccine against vaccinia virus, which is used to protect smallpox endangered people. This vaccine was discovered during an inspection of a San Diego biotech company called StemImmune. The vaccine, combined with stem cells, was injected directly into tumors from terminally ill cancer patients and administered intravenously to two Californian clinics in Landers and Bermans, the agency said. The FDA said the vaccine poses "significant risks," including myocarditis, an inflammation of the heart muscle.
Allan Camaisa, Managing Director of StemImmune, said the company is fully cooperating and will continue to talk with cancer treatment officials. Berman said the FDA misrepresented what the clinics were doing.
In recent months, the FDA has stepped up its regulatory efforts. It formulated procedures to accelerate the approval of legitimate stem cell therapies. It also explained the circumstances under which direct approval of stem cells by the Authority is required.
Gottlieb said of the decision to focus on "high-risk" procedures, that there is only so much to do: "You can not" cook the ocean. "
Many researchers say that the movements are too Temple, the stem cell researcher, bluntly states, "I want the FDA to close all these places tight."
Tyler sits on her bed in the dim light. (19659089) [email protected]
Julie Tate contributed to this report (Zack Wittman for the Washington Post).