Inside Mark Berman's clinic in Rancho Mirage, California, he is forced by law to post it. He reads "Not approved by the FDA."
Patients who come here to the California Stem Cell Treatment Center can get treatments for diseases ranging from sports injuries to muscular dystrophy. For more than $ 5,000, Berman, a plastic surgeon by training, will remove a small portion of their fat, treat it and reinject it.
This is what is called "stem cell therapy derived from fat"; the principle is that the stem cells of your fat can revive the healing process. "Stem cells could be useful for everything from Alzheimer's to paralysis to neurodegenerative diseases," says Berman. "These cells are miraculous to help heal. We do not have a choice. We must use them. "
The problem is that there is not much evidence to corroborate Berman's claims. And it's not just him – there are more than 100 clinicians in the Cellular Surgery Network, a group he co-founded in 2010 to promote the same type of stem cell regenerative medicine that he practices. According to one Report 2017 by three scientists from the Food and Drug Administration of New England Journal of Medicine In examining the benefits and risks of this type of stem cell therapy, "this lack of evidence is worrisome."
Stem cells derived from fats "can have a positive effect," says Brad Olwin, a professor of molecular and developmental biology at the University of Colorado at Boulder, with over 30 years of experience in the field. use of stem cells. "They can be beneficial. it's clearly a possibility. The problem is that the search was not done. "
There is in fact so little evidence that the Department of Justice, on behalf of the FDA, is prosecute Berman's clinic and a clinic in Florida for testing deceptive products on patients. The complaint was filed in May 2018 and the investigation is ongoing, according to the GM.
Given the popularity and abundance of these clinics nationwide, the FDA is also taking steps to modernize the regulations on the ground. Despite these efforts to streamline the legitimacy of stem cell clinics, unregulated medical procedures persist, sometimes resulting in harm to patients.
One of Berman's assistants transfers the extracted stem cells by liposuction from the adipocytes. Berman uses them not only for cosmetic procedures, but also for orthopedic injuries, ALS, MS and Parkinson's disease, with a network of clinics in the United States. Patrick T. Fallon for the Washington Post / Getty Images
Clinics recruit and treat patients despite warnings from FDA and bioethicists
Currently, the FDA only approves stem cell therapy by a bone marrow transplant using pluripotent stem cells to treat blood and bone marrow cancers.
But Cell Surgical network doctors have continued using cells for autoimmune, neurological and other serious diseases.
And there is a growing number of cases of adverse effects. In 2016, an elderly woman became blind after receiving an injection of stem cells to treat macular degeneration. She received treatment at the Georgia Stem Cell Center – a subsidiary of Berman's cell surgery network.
Since then, more and more cases of unfortunate procedures have been reported across the country, the worst having resulted renal failure and paraplegia. In December, the Centers for Disease Control and Prevention reported 12 cases people suffering from bacterial infections following treatment with contaminated stem cells. An investigation traced the infections down to a single provider, Genetech, which prompted the FDA to issue a warning letter to the company. FDA Commissioner Scott Gottlieb then released a public statement reaffirming the intention of the agency to regulate unapproved treatments.
Bioethicists also sound the alarm. In one recent article in the newspaper Perspectives in biology and medicineLeigh Turner of the University of Minnesota has reviewed the marketing claims of 716 stem cell clinics in the United States. Often, he found, they were deceivers. "What at first glance may seem like credible and compliant clinical research is often very problematic," he wrote, adding that the people most affected are those "who often already face serious health problems and other challenges ".
Despite two years of extensive review by the FDA, clinics continue to recruit new patients. Berman insists that recycled fat-derived stem cells should not be subject to the same regulations as other treatments, and that FDA guidelines are arbitrary and unscientific. "They are a violation of constitutional rights on your own property."
He noted that after the woman with macular degeneration who became blind, clinicians in her network no longer inject fat-derived stem cells into patients' eyes. But they continue to offer intravenous (blood) injections. "We have almost three or four adverse events, of very little importance or consequence," said Berman, referring to patients in his network. But according to the FDA, intravenous injections are "Associated with a higher risk."
Other scientists with whom I spoke also expressed concern that intravenous treatment may be harmful to patients. "You take cells from one part of your body and insert them into another. You have absolutely no control after that, "Olwin says. He acknowledges the FDA's efforts to crack down on clinics but suggests that much more needs to be done. "They have limited resources to take on people. But I think it's irresponsible on the part of the doctors and these clinics to promote those things. "
The therapeutic value of fat-derived stem cells lacks evidence
Some types of stem cells can indeed give birth to virtually every cell in the body – providing a platform for muscle regeneration or even organ rebuilding. Stem cells derived from embryos have this power, called pluripotency, but not those obtained from adults. To acquire pluripotency, adult stem cells must be reprogrammed biologically – a feat that, once invented, led to a Nobel prize. These induced pluripotent stem cells allow doctors to treat difficult diseases such as leukemia.
But clinics like Berman do not use pluripotent stem cells, but the mesenchymal system. stem cells found in fat, whose function is much more limited. Arnold Caplan, the pioneer of the field who first assigned them the label "stem cells", recently advocated for renaming them to prevent doctors from claiming that they "can heal the blind, make the lame walk and rejuvenate the old tissues."
BrainStorm, a biotechnology company working with mesenchymal cells, recently got FDA approval start clinical trials to treat patients with multiple sclerosis. But to treat this neurological disease, BrainStorm researchers have developed a method to convert mesenchymal cells into "biological factories" releasing proteins that treat diseases. In other words, BrainStorm treatment does not imply that mesenchymal cells do their own work – something that some Cell Surgical Network clinics claim mesenchymal cells can do.
Outside the Cell Surgical network, other clinics use patients' fat-derived cells, but make different claims about treatment.
"I'm not saying I'm in stem cell therapy," says Dr. Joanne Halbrecht, orthopedic surgeon and founder of Boulder Regenerative Medicine. His clinic uses cells derived from patients' fat to treat orthopedic conditions, injecting them into the joints.
Halbrecht avoids the "stem cell" label because current research does not support the claim that these fat-derived cells can turn into cartilage. Instead, she uses the fat of the patients to cushion their joints. According to Olwin and the FDA, such joint injections pose a much lower risk than intravenous injections.
Berman also administers direct joint injections. But afterwards, he tells me that his clinicians also inject the remaining cells into the patient's bloodstream. Halbrecht is adamant that this type of procedure is unproven and dangerous.
"It's definitive. It's not a question, "she says. "They are completely wrong because there is no science behind that."
FDA Offers Physicians a New Way to Test Stem Cell Therapies
For clinics to be able to prove the safety and effectiveness of their FDA-derived stem cell-derived treatments, they must perform rigorous clinical trials.
But some clinicians argue that even if they were interested in clinical trials, getting the blessing of the FDA is too intimidating. Clinical trials extend over several years and cost millions of dollars. For small private clinics, this process is unaffordable.
In response, the FDA unveiled a more feasible clinical trial process, better suited to small businesses. Clinics wishing to test a specific treatment can now associate with clinical trials and group their patients, saving them time and money. Nevertheless, the FDA offers a grace period of up to 36 months for clinics to comply with its guidelines, allowing many people to continue operating on patients without conducting clinical trials. At the same time, the FDA urges patients to "do [their] part to stay safe, "according to a consumer warning released in May.
Unfortunately, it is not so easy. It is unclear whether a clinic offers FDA-compliant treatment. Some doctors advertise their adherence to the treatment because the device used to remove and treat a patient's fat is technically approved by the FDA. But if they then announce their treatment as "FDA-approved" stem cell therapy, they may mislead patients.
Berman does not plan to continue clinical trials, even with the new simplified process. He thinks that his current model of clinical experimentation is adequate. In "safety studies", it deals with paying patients suffering from a wide variety of diseases. However, according to the recent bioethics report, Turner found that these studies on financial participation are poorly designed and unscientific.
According to Berman, more patients would benefit from getting advanced treatments more quickly. But for every revolutionary treatment developed in a laboratory, there is nine misses and many unpredictable dangers. And unauthorized clinics cost patients thousands of dollars and are not covered by insurance. Critics argue that it is unethical to charge patients for experimental procedures because sanctioned clinical trials cost them almost nothing.
The economic incentives for unauthorized stem cell clinics are clear. Launching clinical trials would not only reduce patients' income, but would also place clinics in a costly process known to last for years. Berman, blaming more and more for government and research, assures me that he and his colleagues are not motivated by their personal interest. "We are the good guys," he says.
In March, the woman blinded by unauthorized stem cell therapy filed a complaint against Berman's cell surgery network. Berman's site still advertises macular degeneration treatment with a link to an application.
But hidden on Berman's website, a kind of admission may surprise the many patients who hear him speak with unwavering assurance. The page reads: "We do not claim that these treatments work for conditions listed or not listed, intentional or implied."
Max Levy is a Ph.D. student in Chemical and Biological Engineering at the University of Colorado at Boulder and Editor-in-Chief of Science buffs, a science blog about graduate students. He writes about health, medicine and the environment.