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Despite the FDA’s crackdown, stem cell therapy is still wild west & # 39;

The treatment seemed an answer to the prayers, courtesy of science. An injection of stem cells, the building blocks of all human tissues, could delay the clock in Loy Roper's aching back, sparing him a third spine surgery.

He then used a credit card to pay $ 9,300 to a Cherokee County pain clinic run primarily by chiropractors and connected to a 24/7 gym.

Roper said a nurse had him lean over a table. Although the clinic's website says that it injects umbilical cord stem cells "directly into the painful area," Roper said the nurse inserted the needle into the muscle of her buttocks, which according to medical experts would have little or no effect on back pain.

"Basically, they just took a lot of money and they did not do anything about it," Roper said. "My butt hurt, my pocket hurt a lot."

Such may be the risks of opening your wallet for stem cell therapy.

Are you limited to a wheelchair? Stem cell therapy may have the power to regenerate damaged tissues, the ads show. Become old? Treatment with stem cells can regenerate the hair, restore virility in the bedroom or relieve sore joints.

"Some of them almost use stem cells as some kind of magic," said Paul Knoepfler, a professor of biology at Davis at the University of California. School of Medicine that blogs about the stem cell industry. "They are basically doing a human experiment, and they are charging people for being guinea pigs."

To a large extent, patients are left to resolve the doubtful of the credible and recognize the risks. Many of the therapies with stem cells in the market remain in the realm of the experimental, with safety and effectiveness not yet proven. For a single treatment, patients may have to pay $ 3,000 or $ 10,000 or more, since insurance usually does not cover it.

Federal regulators stood aside for decades, while doctors and cell biologists have been studying the healing capabilities of stem cells grown from the patient's own blood or fat tissue, or from amniotic fluid or donated umbilical cord blood .

After years of inaction by the Food and Drug Administration, last year the commissioner of the FDA of President Trump announced an offensive against "Unscrupulous providers that take advantage of the hope of patients," seize unapproved products from a California biotech company and send warning letters to a Florida clinic and a New Jersey firm. A statement from the agency said it will "increase our enforcement efforts, particularly in search of products that pose a potentially significant safety concern."

The FDA also said that clinics need a special license if they take a patient's liposuction fat to produce stem cells, treat it with enzymes and then inject it back into the body to treat a variety of conditions. Such injections are now considered new investigational drugs.

A review of the local market conducted by The Atlanta Journal-Constitution found that some clinics were pushing the same types of claims that the FDA criticized last year. At least one clinic seems to announce a treatment that may be in contradiction with FDA regulations on stem cells derived from umbilical tissue. Still others that offer experimental treatments may not have submitted new investigational drug applications required by the FDA.

The AJC found no evidence that the Georgia Medical Board has ever taken action against any physician for promoting unproven claims about stem cell therapy, or the Federal Trade Commission, which may sanction companies for misleading advertising, intervened.

Patricia Zettler, associate professor in the law faculty at Georgia State University and a former FDA staff attorney, said regulators can expect well-publicized letters of advertising from the FDA will deter other clinics.

"It's a bit challenging in this area because so many years have gone by in which the market has developed without the supervision of the FDA," Zettler said. "And thus it is more difficult to control a market that already exists, than to prevent it from developing."

The potential healing power of the body's "master cells"

  • Stem cells are the building blocks of human tissue, capable of dividing and reproducing. They develop in blood, brain, bones and all the organs of the body. The FDA recognizes that they have the potential to repair, replace and regenerate cells, treating a variety of diseases and diseases. For most ailments, science is not yet present, despite what some stem cell clinics show.
  • Stem cell research became controversial in the 2000s with President George W. Bush's battle against embryonic stem cell research. Roman Catholic doctrine opposes such research on the basis that it destroys human life.
  • But most of the stem cell products on the market now do not include embryos, but adult stem cells or stem cells extracted from donated umbilical or placental material.
Source: United States Food and Drug Administration

Eye View of the Blind

Meanwhile, a lawsuit filed by a Florida woman in the Fulton County State Court last month says a stem cell treatment left her totally blind.

Doris Tyler, 77, of the Orlando area, is suing a stem cell clinic in Peachtree City, alleging that she paid $ 8,900 for the treatment of age-related macular degeneration. While Tyler's vision was failing and legally blind, he could still see well enough to cook, read and play the piano.

But ocular disease is considered incurable and experimental stem cell treatments by Japanese researchers have shown promise. the effects. By having the procedure, Tyler thought that she was part of a research study, although her lawsuit claims that the clinic was not part of any legitimate study.

The procedure by Dr. Jamie Walraven of the Georgia Stem Cell Center and Atlanta retinal surgeon Robert Halpern involved removing fatty tissue from Tyler's abdomen through liposuction, centrifuging it in a centrifuge to remove and isolate stem cells, and then injecting the material with a needle in each of his eyeballs, according to the complaint.

Instead of treating one eye at a time to make sure the treatment was safe, his eyes were injected a day apart, the lawsuit says. Within a few months, both retinas separated from the underlying layer, which required several surgeries. Tyler soon lost his vision completely.

One of Tyler's lawyers, Andrew Yaffa, represents three other women who are suing stem cell clinics in Florida, claiming similar treatments left them blind.

"They say they are interested in patients' welfare and safety, and participate in full clinical trials," Yaffa said, "but the reality is that they are interested in taking the patient's money."

Walraven he answered a call from the newspaper last week and Halpern said he could not comment on an ongoing lawsuit, they have not responded to the lawsuit since it has not yet been answered.

The Stem Cell Center website of Georgia still lists macular degeneration as one of the many ailments that can be treated with stem cells, along with multiple sclerosis, Parkinson's, stroke, heart disease, erectile dysfunction, male incontinence and hair loss.


True believers

Another of Dr. Walraven's patients, Kathy Doswell, is considered a satisfied client.

Dosnell, of Snellville, has been diagnosed with multiple sclerosis since 1999. She has had two stem cell treatments since 2014, both by removing fat tissue by liposuction and injecting stem cells into her bloodstream. Each treatment cost around $ 9,000, he said, which he raised with a GoFundMe page and taking a loan.

He said he received his second treatment at Wallraven's office. Doswell said he is considering a third.

"Of all the different things I've tried, it's the only thing that helped me," said Doswell. "In general terms, it was more energy, more flexibility ... I could tell my legs to move, and they would, while before, there was no activity from the brain to the legs."

He still uses a wheelchair. Doswell said the biggest drawback is that the effects fade after about six to nine months, which requires reinforcement.

"It's minimal, but it's better than nothing," he said. "They never promised it would be permanent, they never promised it was a cure, so I investigated knowing that I could get help from it."

In written responses to AJC questions, the FDA said that the use of fat stem cells to treat neurological disorders such as multiple sclerosis is not approved by the FDA and would require the submission of a new research drug application. The AJC could not confirm whether Stem Cell Center of Georgia has submitted one.

Alan Hause, another patient with MS, said he has seen more dramatic results. Last year he traveled to India and paid $ 30,000 for a procedure known as a hematopoietic stem cell transplant, which uses chemotherapy and blood-forming stem cells. The procedure involved the use of chemotherapy drugs to destroy his immune system, draw blood from the neck and then inject stem cells intravenously.

In fact, whoever lives in Jonesboro can now go to church and Braves games without his wheelchair. At home, you can go down the stairs from the door of your house to the sidewalk, barely holding the rails.

"Before leaving, I depended on a wheelchair or what is called a walker, like a walker," he said. "I could not walk alone, and when I came back, I was able to walk with a cane, that's the best improvement I've seen."

Dr. James Bowen, medical director of the Multiple Sclerosis Center at the Swedish Neuroscience Institute in Seattle, does not doubt his story.

"We believe this is legitimate," Bowen said of hematopoietic stem cell transplant treatment. "Our studies show, five years after treatment, that only 70% of people were completely stable in their MS, which is remarkable."

However, he is skeptical about the use of fatty tissue to treat MS, such as Doswell described. There are no solid studies to support that, he said.

"It is difficult to know how much is the effect of the stem cell and how much is the effect of a placebo response," said Bowen. "In the MS world, the response to placebo can be quite powerful."

Regenerative tissue sources used by most physicians

  • Bone marrow aspirate
  • Adipose (fatty tissue)
  • Umbilical cord blood [19659051] Amniotic membrane
  • Blood ] (platelet-rich plasma)
Source: US Food and Drug Administration UU

Changing definitions

When the FDA announced that it would increase the application in stem cell clinics last year, it also acknowledged that some therapies are promising, promising to facilitate legitimate research.

Even so, it is not clear how far doctors can go without sending new applications of investigational drugs to the FDA, which establish plans for human clinical trials and what treatments they can publicly advertise to the public.

AJC found doctors in the Atlanta area who offer stem cell treatment without FDA approval. Doctors at the clinic have argued for a long time that if they're just transplanting stem cells from one part of the body from one patient to another, that's not a medication and the FDA can not regulate it.

The FDA can regulate stem cells as drugs when: [19659018] They are significantly manipulated through processing
  • They combine with other cells, tissues or drugs
  • They are intended to perform a different function in the body that its natural purpose
  • They are being used on a different person who is not a blood relative of the donor and depends on living cells for their primary function
  • Source: US Food and Drug Administration UU

    But if the cells are handled significantly by processing, mixed with other drugs or moved to another part of the body to serve a different purpose, the FDA says it does have competition.

    The agency has also asserted its authority over the use of amniotic or umbilical stem cells, since the tissue comes from another person. The FDA says that such products are only exempt from regulation if they do not trust living cells for their therapeutic effect, which would make "stem cell therapy" false advertising, or if the tissue is used on a blood relative from the donor mother / baby.

    Stem Cell of Atlanta says it uses a product derived from umbilical tissue to treat pain in the hips, knees, shoulders and joints. After the feds reiterated their tissue guidelines last year, the company's website changed from saying it offers "stem cell therapy" to saying it offers "regenerative cell therapy."

    Asked how this material can be used in unfamiliar people, CEO Ross Carter, a chiropractor, characterized injections as allografts, tissue transplants from a voluntary donor to a willing recipient. The growth factors and proteins in the material stimulate healing, he said.

    "It contains stem cells, but we can not call that stem cell therapy because that would violate FDA guidelines," Carter said. He also offers injections using the patients' bone marrow, which he calls stem cell therapy.

    All procedures are supervised by doctors, Carter said. According to Georgia law, chiropractors can not inject themselves.

    Superior Healthcare Group, the Atlanta / Ohio Clinic chain where Loy Roper says he received an injection of buttocks for back pain, still announces umbilical stem cell therapy as "one of the newest and most cutting-edge therapies for chronic joint pain. "

    Steven Peyroux, a chiropractor who runs the clinic in Canton, scheduled a telephone interview with the AJC, but did not answer when a reporter called. He gave limited answers to the questions by email. When asked if he would participate in an FDA trial, Peyroux said: "The FDA only controls tissue laboratories and the safety of their products for now, there are proposal guidelines that have not yet been approved by law."

    ] Regarding Roper's account, Peyroux said: "I can tell you that we do not inject stem cells into the buttocks."

    Clinical medical records says Roper's amniotic injection entered the lower back. But he insists that this is not correct, that the needle entered his gluteus maximus muscle.

    After that, Roper said, the clinic had him come back for a follow-up therapy twice a week, which amounted to chiropractic adjustments of his back and neck He retired after six months, when his doctor in pain management , P. Tennent Slack, told him that the stem cells injected into his back would probably not affect his degenerated spine. [MastusofBlackandBlackandYellowAmnioticinjointsandarteriesofthevertebralcolumnThedirectivesaysthatithasbeenusedforregenerativecelltherapyforapproximatelyfiveyearsbutinlimitedcircumstancesandgenerallywhentheprocedurescoveredbythesafetyareworked

    "If these treatments did not work, all this movement would have died years ago," Slack said. "The results I have seen have been some of the most lasting and effective results of any treatment I can perform."

    But most stem cell therapy is still a new territory for doctors, and how the treatment works at a level is not clear, he said. "Unfortunately," said the doctor, "there is a certain amount of wild west that will continue."

    What the FDA has approved for stem cell therapy for:

    • Blood cancers, such as leukemia, and some metabolic and immune disorders, using bone marrow or transplanted blood cells

    What the FDA does not has approved stem cell therapy for (among other things):

    • Multiple Sclerosis
    • Parkinson
    • Alzheimer
    • Diabetes [19659051] Arthritis
    • Crohn's Disease
    • Asthma
    • Autism [19659052] Hair loss
    • Male incontinence
    • Erectile dysfunction

    FDA warning: stem cell therapy could ...

    • Cause blindness
    • Cause tumors
    • Cause reactions on site administrative
    • Produce the wrong kind of cells
    • Do nothing and be a waste of money
    Source: US Food and Drug Administration UU


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