Merchants of hope Their costly, unproven treatments can be risky. But for-profit stem cell clinics are flourishing. By Erin Allday

In the waiting room of Mark Berman’s Beverly Hills office, the reception counter is crowded with trophies. Mostly made of clear plastic or glass, resembling a row of miniature ice sculptures, they are touchstones of his long career in cosmetic surgery.

For more than three decades, Berman’s focus was breast augmentations and face-lifts. He invented a pocket-like device that can be implanted into the breast to produce better-looking, safer results from augmentation procedures. He calls it his “Sistine Chapel.”

The Miracle Cell This series explores the hope and reality of the revolutionary science of stem cell therapy. It focuses on what has transpired since 2004, when California voters approved a $3 billion bond measure to fund stem cell research with the promise that it soon would produce new treatments for incurable diseases. In four parts, it follows the stories of patients desperately seeking remedies; probes the for-profit clinics where unproven and unregulated treatments are being offered; takes you into the labs and hospital rooms where scientists are testing new therapies; and provides a comprehensive accounting of what California’s multibillion-dollar bet on stem cells has achieved.

But over the past eight years, Berman has reached far past his specialty into a realm of highly sophisticated, still-nascent medicine. He’s become one of the country’s most outspoken and notorious providers of so-called consumer stem cell therapies: using human stem cells to treat a wide variety of ailments despite little or no scientific proof that they work.

With his business partner, Rancho Mirage (Riverside County) urologist Elliot Lander, Berman has built the largest chain of stem cell clinics in the country. Their Cell Surgical Network has more than a hundred affiliates in 33 states — including 38 clinics in California alone — selling treatments they claim will fix everything from knee pain to symptoms of multiple sclerosis.

“As a cosmetic surgeon, it’s kind of a joke that I’m at the center of this universe,” Berman said in an interview last fall. “But I’m kind of ground zero.”

Seven months later, his words became darkly prophetic: In May, Berman and his partner were targeted by the U.S. Food and Drug Administration. The FDA requested an injunction that, if approved by a federal judge, would stop them from selling stem cell therapies.

The FDA issued a similar request against a separate operation in Florida, U.S. Stem Cell Clinic.

Their clinics, though, are just some among several hundred that have popped up across the country in recent years. They are renegade outposts operating with little legitimacy and oversight at the frontier of what is otherwise a highly promising field of medicine.

The allure of stem cells is powerful. Taken from human tissue, they are defined by their ability to transform themselves into most any other type of cell and to replicate over and over — far beyond the limits of mature, fully formed cells that don’t change and can’t reproduce. Stem cells could be used to replace cells in the heart, lungs, bones and brain, to heal a body damaged by disease, injury or aging.

The extraordinary potential ascribed to stem cells has captivated scientists around the world, some of whom have devoted entire careers to studying them. In 2004, California voters were so convinced of their promise that they approved a $3 billion bond measure to pay for research into them.

It’s that sense of possibility that consumer clinics have tapped into. But the stem cells they are selling and those the world’s top scientists are studying are not the same.

None of the treatments the clinics offer have been shown to be safe or effective. None have been approved by the FDA. They’re not backed by decades of laboratory and animal studies or by rigorous testing in humans.

Yet for many patients desperate for care, these clinics fill the void between the long-anticipated potential and the real-world limitations of stem cells. They cater to people whose needs reach beyond the powers of current medicine — people who want to believe in the almost mythic powers of stem cells, who feel corporate health and science have forsaken them.

People who turn instead to these merchants of hope.

For-profit stem cell clinics have come under attack from mainstream scientists and doctors, from disgruntled and disappointed patient-customers, from the FDA and other regulatory agencies. Yet they have managed to thrive.

There’s no registry of these clinics, no licensing authority at the state or federal level, no way to know exactly how many exist. A recent report on the industry offers one measure: In 2008, there were no U.S. clinics marketing stem cell therapies online. By 2010, it found, there were about a dozen. In 2016, there were at least 570, according to a paper published in Cell Stem Cell.

That number has almost certainly increased since. The authors of the report — UC Davis scientist Paul Knoepfler and University of Minnesota bioethicist Leigh Turner — believe there are now 700 or more consumer stem cell clinics in the United States, and that up to 20,000 people have undergone their treatments.

There are hubs in Florida and parts of Texas, their report says, but a fifth of the clinics are located in California. Clusters of them operate in Los Angeles and San Diego. Berman’s is one of eight or more clinics located along a 1-mile strip in Beverly Hills, among the Hermes and Louis Vuitton boutiques.

The Bay Area is home to at least a dozen such clinics, a simple online search shows. More are located in Monterey, Sacramento and Redding. About half of the Northern California clinics specialize in treating chronic pain, orthopedic issues or sports injuries. Others claim to treat complex neurological and immune conditions.

The providers are usually, though not always, licensed doctors, but they often are working far outside their fields of expertise. They advertise on social media and in newspapers. They host seminars and online lectures. Many promote therapies that federal guidelines plainly state are not allowed.

Some clinic websites list the illnesses and injuries they claim to treat in neatly categorized drop-down menus. One shows a diagram of a man not unlike the patient in the old board game “Operation,” with arrows pointing to his knees, shoulders, feet, eyes, heart and brain. “The Stem Cell Revolution,” a book by Berman and Lander, lists 47 conditions they say they or their colleagues can treat.

High-end shopping, luxury salons — and stem cells Beverly Hills appears to be home to the largest cluster of for-profit stem cell clinics in the United States. In an area along a one-mile stretch of Wilshire Boulevard, bisected by the world-famous Rodeo Drive, at least eight stem cell clinics operate. At one end of Wilshire is the office of Cell Surgical Network founder Mark Berman, and at the other is the clinic of Nathan Newman, a cosmetic surgeon who specializes in stem cells for face-lift procedures. The Beverly Hills clinics are pressed between juice bars, jewelry boutiques and posh outlets of international brands like Hermes and Louis Vuitton – along with organic pharmacies, day spas and many plastic surgery offices. Nathan Newman, a cosmetic surgeon in Beverly Hills, uses stem cell therapy to treat a patient with facial disfigurement.

These clinics work with what are known as adult stem cells, usually harvested from tissue taken from a patient’s own body and returned by injection. Patients are told that their very own cells can treat almost any ailment and can do more for their health than drugs or surgeries that have already failed.

For-profit stem cell clinics in the United States generally use mesenchymal stem cells, a type of adult stem cell. These cells can repair or replace connective tissue — such as fat and cartilage — throughout the body, though they typically become tissue associated only with the organ in which the stem cells are found. In other words, fat stem cells are not likely to become cartilage and bone marrow stem cells are not likely to become fat. The clinics use one of three types of stem cell products. There is almost no evidence that therapies using these products are effective, according to the FDA and critics of the consumer industry. Fat-derived stem cells Doctors draw fat from the patient, usually from the belly via liposuction, then use chemicals and a centrifuge to melt away the fat and separate other unwanted material. The resulting mix, which is called stromal vascular fraction, or SVF, includes several different cell types; there is debate as to how many stem cells remain after all the processing. The FDA says that the process used to make SVF could expose people to risk, such as from infection, if the sample becomes contaminated, or an immune reaction to the chemicals used. Bone marrow-derived stem cells Doctors insert a needle into the patient’s pelvic bone to collect a sample from the liquid portion of the bone marrow. The sample is put into a centrifuge to separate stem cells and other types of cells from the fat and connective tissue that make up bone marrow. Amniotic stem cells This product comes from the amniotic fluid and tissue that surrounds a developing fetus. Companies that specialize in collecting and processing these cells typically get the product from donors who provide the amniotic fluid after childbirth. After being put into a centrifuge, the final mix is frozen and distributed to clinics. Many experts say the final product has few, if any, living cells by the time it is given to patients. All of these products are most often administered either by intravenous infusion or by injection into the injured site. Some clinics use a nebulizer, so patients inhale the cells directly into their lungs. They also are sometimes delivered by shunt into the brain or spinal cord.

It’s a promise that resonates with Baby Boomers resisting old age, with a generation of younger patients with chronic, sometimes fatal, diseases who are running out of time, and with a broader American population that is impatient and empowered when it comes to managing their health care.

The cost of a single treatment typically ranges from about $2,000 to $20,000, though it can be much higher, according to informal patient surveys that Knoepfler has done. Often several treatments are recommended. These therapies are not covered by insurance and many clinics promote payment plans on their websites. Thousands of patients have turned to crowdfunding websites sharing heartbreaking stories of chronic illnesses, fatal diagnoses and devastating injuries in their requests for money to pay for stem cell treatments.

Reports have emerged of some terrible outcomes related to commercial stem cell therapy — cases of people who have been blinded or whose conditions deteriorated after they were treated. One man developed tumors after multiple stem cell treatments. Several people who sought stem cell therapies overseas have died. But the full extent of risks from these therapies is unknown, because no one organization tracks them.

The California Institute for Regenerative Medicine — the state agency created by Proposition 71 in 2004 to fund stem cell research — has raised concerns about the thriving consumer therapy market. CIRM officials and many of the scientists they fund worry that the selling of unproven treatments could undermine their own work and cast doubt on the enormous potential of regenerative medicine.

But until the recent FDA complaints, enforcement of federal guidelines on appropriate use of stem cells had been scarce, say critics of the for-profit industry. The guidelines themselves were formalized only last November — years after critics had raised warnings about the risks consumer clinics posed.

Patients often contact doctors and stem cell scientists to ask about the unproven treatments sold at for-profit clinics. Rarely will the doctors or scientists endorse one of these stem cell therapies, but they sometimes will arm patients with questions to ask, including: Have the providers filed an investigational new drug application with the Food and Drug Administration? This is a permit that means the FDA has oversight of the product, even if it has not yet been approved. Note that just filing an application does not mean the FDA has issued a permit. It’s important to ask about the status of the application, too. Are they conducting clinical trials? Clinical trials also imply federal oversight. But not all clinical trials meet scientific standards, so a simple yes isn’t enough. Ask about pre-clinical data to support the trial. Ask whether results from the trial will be published. Ask about the cost: Patients occasionally have to pay a small fee to join a legitimate clinical trial, but the cost should not be inordinate. Do the providers have experience with the conditions they say they can treat? If a cosmetic surgeon is treating multiple sclerosis or a dermatologist is treating Parkinson’s disease, that’s cause for concern. What are the risks of this therapy? There is almost always a risk of side effects from any treatment. If the doctor says there are no risks, that’s a red flag.

“Some of these places, they’re very much just focused on the profit. Some of them are just rebels. But some of them, do they genuinely believe in stem cell magic?” said Knoepfler, a professor of cell biology and human anatomy at UC Davis. Whatever motivates them, it hardly matters, he said.

“Patients need to approach all of them with skepticism,” he said. “I get it. It’s hard to be patient. I understand if you’re miserable, if you’re partially paralyzed or have debilitating arthritis or you’ve had COPD for 20 years and you’re looking for a game-changer. But if something sounds too good to be true, it probably is.”

Mark Berman has thick, highly styled, slate-gray hair, and at the end of a midweek day, his navy blue scrubs are crisp and neat. He keeps a sample of the breast-pocket device and a copy of his stem cell book at hand in his office. On his desk is a sculpture of a dragon, his Chinese zodiac sign. Dragons, it’s said, are hot-headed, intelligent, risk-taking.

An animated conversationalist, Berman speaks with a kind of relaxed confidence that’s both charming and intimidating. It’s easy to understand why some people are eager to trust him, and others more apt to doubt.

From memory, he recites patient testimonials and notes lab and animal studies that he says support his work in stem cells. He claims that he and his colleagues have successfully treated people with multiple sclerosis and Alzheimer’s disease, brain injuries and bum knees. His wife benefited from stem cell injections in her hip, he said. He’s treated himself for sciatica.

The work, he says, fills him with an enthusiasm he hasn’t experienced since his earliest days out of medical school. He sees himself as a pioneer in a field that’s just blossoming, and will transform the practice of medicine.

That field has come to be known as regenerative medicine, so called because it focuses on rebuilding the body to heal damage done by illness and injury. Scientists have long thrilled to the concept, but only in the past couple of decades have any strides toward actual therapies been made.

Theoretically, stem cells could be used to replace cardiac muscle damaged in a heart attack, nerve cells destroyed by spinal cord injury, bone and cartilage wasted with age. Mainstream doctors and scientists say that and more is possible — someday, with the right kind of stem cells, under the right circumstances. The right kind of stem cell, though, is not what’s being sold in consumer clinics.

Berman, along with almost all providers at for-profit clinics, uses autologous adult stem cells — autologous meaning they come from a patient’s own body. Unlike embryonic stem cells, which build every part of a developing human body, adult stem cells are limited in their abilities.

Embryonic stem cells, along with laboratory-generated induced-pluripotent stem cells, can turn into every other kind of cell and regenerate themselves endlessly. Adult stem cells can turn only into certain types of cells and will eventually stop replicating. They are found in pockets — in bone marrow or in certain organs, for example — and develop into the types of cells found in the tissue from which they came.

Though less powerful than embryonic and induced-pluripotent stem cells, adult stem cells have advantages. They are easily accessible and relatively cheap to obtain. There is evidence that certain adult stem cells may act as potent anti-inflammatories, say some scientists.

Adult stem cells also are less controversial than embryonic stem cells, which come from embryos that are destroyed during the process of isolating them. Some of the top stem cell experts in the world believe that adult stem cells may be better suited for certain therapies than embryonic stem cells.

But those same experts say that prospect is years, if not decades, away. Berman says it’s already here.

He and other for-profit providers say adult stem cells can home in on damaged parts of the body and perform different healing functions. In the eye, they say, stem cells can help replace the light-sensing rods and cones damaged by disease. For a systemic illness like multiple sclerosis, in which an overactive immune system attacks the body’s own nerve cells, stem cells can help rebuild damaged cells and improve immune function, they say.

These claims — if there’s any evidence for them at all — usually are based on laboratory studies of cells in Petri dishes, not on controlled tests on animal or human subjects. Proof that stem cells can actually help people is almost always anecdotal.

Scientists performing the most rigorous research say that what Berman and other for-profit providers suggest is not possible. Adult stem cells taken from fat — the technique Berman uses — cannot replace cells in the eye. They won’t target an injured area of the brain. They won’t float around the body healing the immune system.

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To critics, Berman said, “We’re a bunch of quacks and scallywags ... we’re charlatans and taking advantage of people.

“That’s ridiculous,” he said. “Why would I be doing this unless it was incredibly successful?”

Critics point to one answer: money.

Procedures at Berman’s clinics cost $8,900, though he said he’ll reduce or waive costs for patients in need. He and Lander also charge doctors who join their network about $30,000 for training and equipment, including a device they call the “time machine” — a reference to stem cells’ fabled ability to reverse the effects of aging — to make the product they use in treatments.

Berman said he understands the value of rigourous, long-term research to test the safety and efficacy of new therapies. But he’s convinced that what he’s selling is already helping people. And if he’s able to offer a treatment now, even if it’s imperfect, “that’s our moral duty,” he said.

“We’re taking people with absolutely no chance, and we’re giving them a little hope.”

In the medical realm, the notion of hope can be divided broadly into two categories: the probable and the possible.

Mainstream medicine is largely based on the probable — what science has shown is the likely outcome of illness or injury and the treatments applied. Probable hope is based on statistics, evidence and careful analysis.

Possible hope, by contrast, is more “what if?” If probable hope says a treatment is 99 percent likely to fail, possible hope says: What if I am the 1 percent?

The providers of consumer stem cell therapies operate largely in this latter domain. It’s a model of care that feeds on the irresistible desire of most people to hope for the best — to believe that they will be the one for whom an untested, unproven treatment will work.

“Most patients, and their loved ones, their families, they’re operating on this model in which anything is possible,” said the Rev. Peter Yuichi Clark, director of spiritual care services at UCSF. “Medical advances are happening every day. Maybe there will be a treatment that responds to my particular condition.”

Hope drove Auburn resident Katie Gwinn through six stem cell treatments that cost her more than $100,000.

She got her first treatment in 2013, at a clinic in Panama that’s become a destination for people with certain conditions, particularly multiple sclerosis and autism. Gwinn has MS, and though the disease progressed slowly at first, by 2010 she’d had to stop working due to fatigue and pain.

She was only 54 at the time and not ready to consider herself permanently disabled. But drugs that were supposed to slow down progression of the disease didn’t seem to be working. She was tired all the time. Her right leg was stiff and hard to move.

Online, Gwinn found the Stem Cell Institute in Panama City, which uses adult stem cells taken from donated umbilical cord tissue. After her first treatment, she felt like she had more energy. Her right leg was stronger, her limp less noticeable. But after eight or nine months, the benefits faded. When she repeated the therapy a year and a half later, the results were less impressive. Each treatment cost her nearly $20,000.

Gwinn then found another clinic, StemGenex, in San Diego. The doctors there said they would treat her with stem cells extracted from her own fat. It was cheaper: $15,000, and she wouldn’t have to travel to another country.

But after her visit there in 2015, she didn’t notice any change in her condition. “I was extremely disappointed,” she said.

Ultimately, she would return to Panama for three more treatments, but finally decide that whatever slim benefits she received weren’t worth the cost.

She’s 62 now and on a new drug, approved by the FDA in 2016, that slows progression of MS in some patients. Her doctor said they should know by the end of this year if it’s working for her.

In hindsight, she realizes the therapy she got in San Diego was not going to work. The doctor who treated her had a background in cosmetic surgery, and no formal training in multiple sclerosis. She’d been overly hopeful. Desperate.

“It was a plastic surgeon’s office,” Gwinn said. “They were just taking out the cells and spinning them around and putting them right back in. What they’re doing for MS is not a darn thing.”

Still, she says she doesn’t regret the time and expense she invested. It was a costly foray into the limits of hope, but one she felt she needed to make. And she hasn’t entirely given up on stem cells. They might help some people, someday — just probably not her.

Others are far more critical of the clinics.

Some stem cell providers may truly believe they’re helping people, said David Spiegel, a Stanford psychiatrist who is chair of the university’s advisory panel that oversees its research involving stem cells. Most, though, are well aware that what they’re selling isn’t real, he said.

“The idea that it’s this magic cure is greatly exaggerated,” Spiegel said. “At the moment, most of it in clinical practice is snake oil. … I don’t have much of a sense of humor about these practitioners and companies that are fleecing people on false hope.”

For every warning about unproven stem cell therapies, though, there are stories that boost their legitimacy: endorsements by satisfied customers, name-drops of celebrity patients.

San Francisco Giants’ pitcher Mark Melancon had been sidelined by an elbow injury for months, despite surgery and working with top physical therapists. In April, he had stem cells injected into the injury site. Doctors didn’t claim the treatment would cure him, but hoped it would speed his recovery.

Two months later, just about the time the team had expected after surgery, he was back on the mound.

The doctor who recommended the stem cells — James Andrews, of the Andrews Institute in Florida — says he has done similar therapy with hundreds of professional athletes. And it’s not just current athletes crowing about stem cells. Golf legend Jack Nicklaus credited a stem cell therapy in helping him recover from a post-career injury. The family of hockey star Gordie Howe claimed stem cells helped prolong his life after a stroke; he died in 2016.

Testimonials by patients and their families, often featured prominently on clinic websites, are especially powerful lures to prospective clients. In a video made for the Panama clinic that Gwinn visited, actor Mel Gibson says that his 93-year-old father’s quality of life improved dramatically after being treated there. Other clients share stories of “miracle” recoveries, of feeling better than they have in years.

The suggestion is clear: Stem cells healed me, and they could heal you, too. Such endorsements have helped give stem cells credence among an increasingly mainstream audience.

“It’s night and day for me,” said Jon Brandstad, 70, a Stockton-area farmer who received stem cell injections in his left shoulder at a clinic in San Rafael two years ago.

He heard about stem cell therapy on an episode of the TV show “The Doctors.” At the time, Brandstad couldn’t lift his arm over his head. He was having trouble dressing himself and working his farm. An orthopedic surgeon recommended a shoulder replacement — he called stem cells “voodoo” — but Brandstad didn’t want surgery.

The stem cell injection didn’t cure him; he says it was about “40 percent” effective in relieving his pain. That was enough to get him back to work. It also convinced him to return for more injections, in his right shoulder and a knee. He spent $6,000 for each treatment, none paid for by insurance.

Patients who have become advocates for stem cell therapies say that cases like Brandstad’s demonstrate that the FDA should largely stay out of the industry, that individuals should be able to decide on their own treatment.

Jennifer Ziegler is a founder of Patients for Stem Cells, an advocacy group with 2,000 members that is pushing for increased access to therapies in the United States. Texas has been a hub of for-profit stem cell marketing for seven years, since then-Gov. Rick Perry was treated for back pain in 2011 and hailed his results.

The clinic where he was treated, Celltex in Houston, was taking patients’ stem cells and multiplying them in a lab before re-injecting them — a process the FDA said was not allowed. About a year after Perry was treated there, the FDA ordered Celltex to stop making stem cell products, and the company moved much of its consumer business to Mexico.

Ziegler, who was also a Celltex patient, said forcing the operations out of the country was an overreaction, and that FDA regulations unfairly limit patients’ rights to make decisions about their health.

Ziegler has multiple sclerosis. The drugs to treat it had intolerable side effects for her. so she sought stem cell therapy. After Celltex shut down its Texas clinic, she traveled to the Stem Cell Institute in Panama.

“There’s a cliff you get to as a patient where you either jump off and give up, or you try to find another answer,” Ziegler said. “It’s horrible that it’s not allowed in our country and it’s not covered under insurance. We’d like stem cells to be available to anyone who needs it.”

Last September, Texas Gov. Greg Abbott signed a bill that grants patients with severe chronic or terminal illnesses increased access to therapies using adult stem cells that are not yet federally approved. Ziegler’s group pushed for that legislation and intends to champion similar laws in other states.

Health Link Medical Center, the San Rafael clinic where Brandstad was treated, is located in an office building just off Highway 101, across from a shopping mall where patients sometimes wait between appointments.

A few miles up the freeway is the Novato hotel where Health Link holds weekend seminars for prospective patients — typically middle-aged men and women with bad knees, hips, backs and shoulders. A few miles beyond that is the Buck Institute for Research on Aging, a major stem cell laboratory and the recipient of nearly $35 million in CIRM funding.

Health Link is affiliated with Regenexx, one of the largest providers of stem cell therapies using cells taken from a patient’s own bone marrow. Thirteen years ago, when Regenexx first started treating people at its founding clinic near Boulder, Colo., the company would isolate the stem cells and multiply them in a lab over several days — similar to what Celltex was doing in Houston. The process meant patients could get a much higher dose of stem cells.

But, as it did with Celltex, the FDA halted that practice. In 2011, Regenexx moved its cell-culturing business to the Cayman Islands. Now, in several dozen offices across the United States including seven in California, Regenexx’s stem cell therapy is a one-day outpatient procedure. Doctors collect a bone marrow sample, separate out and concentrate the stem cells, then inject the concentrate into the injured part of the body.

Arguably, the cells that Regenexx gives patients make sense for treating orthopedic conditions. They use mesenchymal stem cells, a type of stem cell meant to become the body’s structural tissue. Mesenchymal stem cells from bone marrow may turn into cartilage, for example, though many experts say there is little evidence that the cells work that way after being removed and re-injected.

Certainly, though, mesenchymal stem cells, which are also found in fat tissue, do not become brain or heart cells. They cannot replace cells in the eye that sense light.

“There are a few people who are doing things that are pushing the envelope with very little information, and they’re getting bad outcomes,” says Stephen Derrington, a Health Link doctor. “What ends up happening is we all get lumped into one big category of ‘stem cells,’ no matter what they’re being used for.”

The FDA would seem to agree. Its stem cell guidelines allow for “homologous” use, which means the cells are used in a way similar to their natural role in the body. So providers like Regenexx that primarily do orthopedic procedures do not need FDA oversight, said Norman Deitch, chief executive of Health Link, which has three other California locations besides San Rafael.

The FDA hasn’t quite given places like Regenexx the all-clear. But at least for now, the agency is much more focused on clinics, especially those using fat stem cells, that claim to treat conditions like multiple sclerosis, Parkinson’s disease or blindness.

The FDA’s move against Berman and Lander’s operation, along with the Florida stem cell clinics, was its most aggressive strike so far against the consumer industry. If a judge approves the request for an injunction, more than a hundred clinics could be forced to stop selling stem cell therapies.

The legal maneuver followed more than a year of media focus and speculation in the greater scientific community: reports of patients badly injured by treatments, of lawsuits and settlements, of federal inspections and even a raid by U.S. marshals. Berman said he is fighting the FDA with a “top notch” team of lawyers.

Read more The federal complaint against California Stem Cell Treatment Center and Cell Surgical Network (PDF)

Berman and Lander founded their first clinics, a network of offices called California Stem Cell Treatment Center, in 2010. Two years later, they began training and selling equipment to other doctors who wanted to join their newly formed Cell Surgical Network.

Clinics in the network maintain a registry of patients to keep track of the conditions people are seeking care for, how they are treated and whether patients were satisfied with the results. Berman said 9,000 people have been treated in the network so far. The satisfaction rate depends on the injury or illness being treated, he said; for some conditions, 80 percent or more of patients are happy with the outcome. Almost none have suffered serious side effects, he said.

The FDA used that same registry, though, to find cases of people who had suffered infections or other complications. It cited the registry in its case to shut down Berman and his partner’s clinics, to stop them from “experimenting on patients with adulterated and misbranded drugs.”

The raid by U.S. marshals was last August. At the request of the FDA, marshals confiscated stashes of smallpox vaccine from a company called StemImmune that was affiliated with California Stem Cell Treatment Center.

Scientists had been mixing the vaccine with stem cells, and doctors injected the product into patients with late-stage cancer. Some studies have found that smallpox vaccine may boost the effects of cancer-fighting drugs because the vaccine tends to target cancer cells.

But according to the FDA, the vaccine can put immune-compromised patients — such as people with cancer — at risk of life-threatening side effects like swelling of the heart, brain or spinal cord. StemImmune did not have federal permission to perform the experiments, authorities said.

Two months earlier, FDA inspectors had visited two clinics operated by Berman and Lander in Southern California. They found violations that they said put patients at risk of exposure to dangerous microorganisms. The federal complaint cites several examples of patients who reacted badly to stem cell treatments.

One person was hospitalized after having stem cells injected into the brain. A woman couldn’t walk for six months due to an infection she got after a stem cell injection in her knee. A person with lung disease lost consciousness and was hospitalized after getting stem cells by injection and through a nebulizer.

All of those incidents took place at Berman’s Beverly Hills clinic. Berman said the patient complaints were all overstated and there’s no proof that the problems were directly caused by the stem cell treatment.

Read more The lawsuit against Cell Surgical Center (PDF)

Then there’s the case of Doris Tyler, who was left blind after a stem cell injection at a clinic that’s part of the Cell Surgical Network. In March, she sued the clinicians who treated her, along with Berman and Lander, accusing them of negligent treatment and making false claims about the therapy they sold her.

Tyler, now 78, was slowly losing her vision to macular degeneration when a friend gave her a copy of Berman and Landers’ book, according to the lawsuit. Tyler was hopeful that the treatment they offered could stop her vision loss, maybe even improve her sight.

She found a clinic, Stem Cell Center of Georgia, within driving distance of her home in central Florida. On Sept. 7, 2016, Tyler met with the providers, who confirmed that she could benefit from a stem cell treatment. She signed papers consenting to the procedures and paid $8,900.

The next day, a doctor drew fat from her belly, isolated stem cells from it, and injected them into her right eye. A day later, they did it again, injecting her left eye.

By Sept. 12, Tyler was experiencing blurred vision and bleeding in both eyes. By Oct. 3, the retina had peeled away from her left eyeball. By the end of the year, the retina in her right eye had detached too.

Before the stem cells, the lawsuit states, Tyler could still see the faces of her children and grandchildren. She could cook, read and play the piano.

“At the present time,” it says, “she is totally and permanently blind in both eyes.”

Berman said every clinic in the Cell Surgical Network stopped offering eye procedures after the incident with Tyler. But he insists that the injections had helped some patients recover their vision. On the company’s main website, macular degeneration is still listed among conditions its providers will treat.

Tyler’s was the fifth known incident in the country of someone apparently blinded by a fat-derived stem cell procedure. The four other cases — which all occurred in 2015 in Florida — involved U.S. Stem Cell, the company targeted by the FDA along with Cell Surgical Network. U.S. Stem Cell has settled lawsuits with two of the patients who said they were blinded.

Just as the first cases of blindness began to be reported in mainstream media outlets early last year, a small California company was beginning to recruit subjects for an FDA-backed clinical trial using stem cells to treat macular degeneration.

Clinical trials are the final stage of scientific research before a new drug or therapy goes up for federal approval. How trials are conducted can vary widely, depending on how far along the research is, whether the therapy is being tested for safety or efficacy, and what type of therapy is being evaluated. Saying that something is being tested in clinical trials can give a therapy an undeserved veneer of legitimacy. It implies that it’s already been vetted, that the government has some oversight, and that patient outcomes are being closely monitored. That’s not always the case, though. Many for-profit clinics claim to be conducting clinical trials, but their version of a trial may be very different than trials performed with consent from the Food and Drug Administration. Clinical trials should have a detailed plan that’s been approved by the FDA has approved. That plan almost always involves regular follow-up after the therapy, to monitor long-term safety and efficacy. It will include strict guidelines that lay out exactly how the therapy is to be given and what any risks are associated with it. Crucially, patients should not have to pay to participate in a clinical trial. If they are asked to pay a large fee — several thousand dollars are or more — that means the trial likely is not funded by a legitimate research company or a nonprofit institution like the National Institutes of Health or the California Institute for Regenerative Medicine. Also, asking patients to pay to participate can interfere with objectivity in the trial results. Patients can look up trials they’re interested in at the government-run website clinicaltrials.gov — but even a listing there isn’t a guarantee that a trial is legitimate. Last year, after complaints that some trials it listed weren’t meeting scientific standards, the site added a disclaimer: “The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.” In other words: Enter at your own risk.

“It really hurt our recruitment,” said Jane Lebkowski, president of research and development at Regenerative Patch Technologies in Portola Valley. “We got a lot of questions: What happened in Florida? Am I going to go blind too?”

Most patients, Lebkowski noted, don’t understand the difference between the fat stem cells that a for-profit clinic is using and the complex product her company is developing, which uses embryonic stem cells to develop a kind of retinal cell that’s damaged in macular degeneration.

That’s part of the reason why scientists like Lebkowski and organizations like CIRM, which gave $17 million to the Regenerative Patch trial, have pressured the FDA to crack down on the consumer market. They argue that for-profit clinics aren’t just putting patients at risk, but the very science itself.

The formal guidelines released by the FDA late last year clearly stated that the fat stem cell product many clinics use cannot be given to patients without federal permission. But by then, it had become one of the more popular consumer stem cell therapies in the country. A couple hundred clinics were using it.

Though encouraged by the recent moves, scientists who have pestered the FDA for years to increase oversight of for-profit stem cell clinics wonder why it took so long.

Leigh Turner at the University of Minnesota sent a letter to the FDA five years ago warning that Berman and Lander’s operation appeared to be providing unsafe, unproven therapies.

Knoepfler, too, had been trying to get the FDA’s attention. He’s run a popular stem cell blog for nine years, in large part about the consumer industry. A post there from February 2017 — an interview in which Berman and Lander talk about their use of fat stem cells — is cited in the FDA complaint against them.

“I would reach out to people at the FDA (to report a problem), and they’d say, ‘We know, we read your blog.’ But then nothing would happen,” Knoepfler said. “All these years when Leigh and I and others were saying, ‘Hey, we have a problem’ — why did nothing happen?”

The FDA had issued seven warning letters, three of them to one manufacturer, over 3½ years before the injunction requests. It had shut down the cell-growing operation of Regenexx, but the company was still allowed to give other stem cell therapies to patients.

Other agencies had exercised some oversight. In North Dakota last November, the state attorney general’s office investigated a clinic after receiving several consumer complaints. The clinic eventually agreed to stop doing stem cell procedures. In California, the state medical board revoked a doctor’s license in 2014 for marketing stem cell therapies, but that physician had been working primarily in Mexico.

Last October, California became the first state in the country to mandate that consumer clinics inform patients that their therapies are not approved by the FDA. Washington state has passed similar legislation. But neither of those laws prevent stem cell therapies from being sold.

Some dissatisfied customers have sued. Two years ago, StemGenex — the San Diego clinic Katie Gwinn went to — was sued by former patients alleging it made bogus claims of a “100 percent satisfaction” rate among clients. The company has stood by its statements. About a dozen similar lawsuits have been filed nationwide, according to a report published last year in the journal Regenerative Medicine.

Scientists, too, have a role to play in curtailing the consumer industry, said Jan Nolta, director of the UC Davis Institute for Regenerative Cures. It was scientists, after all, who first exalted the potential of regenerative medicine, and who touted their own incremental successes in stem cell research; California’s Prop. 71 used promises of near-future cures to win voter approval back in 2004.

“We do have a responsibility here,” Nolta said. “We try not to hype what we’re doing. We try to be very monotone and understated. And these clinics are claiming they can do these crazy things. We need to balance patients’ expectations.”

But lawsuits, cautions from scientists and warning letters from the FDA seem to have done little to deter stem cell therapy providers. Now that the FDA has threatened to shut down two of the most prominent stem cell businesses, critics of the consumer industry said they’re curious to see how other providers react.

Knoepfler said he thought some smaller for-profit clinics might reconsider the stem cell therapies they offer. But even if the new FDA complaints slow down or stop marketing of certain products, these clinics have clearly taken root.

“This big action, it highlights how little happened before,” Knoepfler said. “Imagine if you rewound several years, when Cell Surgical Network only had like 20 affiliates instead of 100. If you had addressed the problem when it was tiny, that’s way better than after it blows up.

“Tens of thousands of people have gone through these places now,” he said. “It’s an industry.”

Standing before a couple dozen prospective patients crowded into a back office of his chiropractic clinic, Brian Coyle boasted about the unrivaled potential of stem cells.

Coyle was warm and charismatic. He asked thoughtful questions about their conditions — diabetic neuropathy, arthritis, pain from old knee and shoulder injuries — and murmured and nodded as they reported the hurdles they’ve encountered in mainstream medicine.

Knee replacements have failed to alleviate their pain. Recovery from hip surgery has taken months longer than expected. Narcotics and other prescription drugs do nothing for their neuropathy, a burning nerve pain.

Advanced Health Center, Coyle’s San Jose clinic, had something that would help, he said. And if they signed up for stem cell therapy that day, they could get a discount — $1,000 off the usual $7,000 cost.

Stem cells, he told them, have won scientists Nobel Prizes. Famous athletes use them to treat injuries and prolong careers. At Stanford, doctors are using stem cells to help stroke patients walk and talk again.

All true — but it’s complicated.

The Nobel Prize went to a Japanese researcher for discovery of a complex technique to make stem cells out of other types of cells in the body. The first attempts at using these cells in human beings have just begun, and only in Japan.

With the athletes, often there are no details about what kind of stem cells they were treated with, or what other treatments they received that may have helped them recover.

The Stanford therapy involves drilling a hole into patients’ skulls and transplanting stem cells — specifically, mesenchymal stem cells that have been modified in a lab to help improve neurological function — directly into the brain. Gary Steinberg, the neurologist running the study, says it’s too early to say whether the stem cells caused his patients to improve.

“There are still lots of unanswered questions. And we don’t want to oversell this,” said Steinberg. He’s aware that some consumer clinics use his research as proof that their stem cells will work, but he’s not sure what he can do to stop them.

“They show videos of our patients, who were wheelchair-bound and now are walking. That’s a little deceptive. I don’t like it, and we discourage it,” Steinberg said. “But we don’t like Russians meddling in our elections. This is the way the world is.”

Coyle — like Brandstad, the Stockton farmer — stumbled upon stem cells as therapy about three years ago on an episode of “The Doctors.”

“It was a shoulder problem, a guy had a tear in his shoulder,” Coyle said. “He did the stem cells and four months later it was healed. I don’t think I even knew the different types of stem cells then. But it looked very promising.”

Intrigued, Coyle studied the market. Using stem cells from bone marrow or fat seemed too invasive — too surgical — for his clinic. He could use stem cells taken from blood, but he wasn’t impressed by the results.

He decided to use amniotic stem cells, which are drawn from amniotic fluid and tissue donated by women who have undergone C-sections. He gets his supply from a company in Scottsdale, Ariz., that specializes in stem cell products.

Providers of amniotic stem cells tout their healing powers, but many mainstream scientists say the product may not be stem cells at all. There’s debate around whether many stem cells are found in the amniotic fluid in the first place, and scientists say it’s unlikely the cells are alive or active after they’re harvested and processed.

The FDA guidelines suggest that amniotic stem cells require federal oversight, though the agency has mostly left those providers alone. But Coyle said patients should be able to decide for themselves what kind of treatments they want.

“If you have someone with multiple sclerosis or cancer, and they want to do IV stem cells — they should be able to do pretty much whatever they want to do to change their life,” he said.

As his lecture ended, Coyle took a few questions from his audience. It was largely an older crowd, men and women leaning heavily on canes and walkers, though a few younger people were there too, wanting to avoid a knee or shoulder surgery or to stop relying on drugs for their pain. Some had been skeptical during the lecture, even snorting softly at a few of his claims.

But after he repeated his $1,000 discount, they lined up for the free boxed lunches he provided. Then they lined up again in the lobby to make their appointments.

Maybe this would work. Maybe this would help. They had to hope.

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