Stem Cell Clinic

Stem cell market: Inside California’s flourishing for …

The Miracle Cell

Part 1

Part 2

Part 3

Part 4

About Stem Cells

Patients

Patient Jon Brandstad is prepared for a stem cell procedure at Health Link Medical Center in San Rafael. Gabrielle Lurie, The Chronicle

Merchants of hope

Their costly, unproven treatments can be risky. But for-profit stem cell clinics are flourishing.

Aug. 2, 2018

In the waiting room of Mark Bermans 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, Bermans 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 Californias 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. Hes become one of the countrys 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 affiliatesin 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, its kind of a joke that Im at the center of this universe, Berman said in an interview last fall. But Im 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 havepopped 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 dont change and cant 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 extraordinarypotential 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.

Its that sense of possibility that consumer clinics have tapped into. But the stem cells they are selling and those the worlds 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. Theyre 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.

Theres no registry of these clinics, no licensing authority at the state or federal level, no way to know exactly how many exist. A recent reporton 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. Bermans 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 ofthe 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. Manjula Varghese, The Chronicle

These clinics work with what are known as adult stem cells, usually harvested from tissue taken from a patients 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.

Its 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.

A woman walks by a Dior advertisement on Rodeo Drive. Among the clothing stores and handbag boutiques in swanky Beverly Hills are several stem cell clinics. Scott Strazzante, The Chronicle

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 concernsabout 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.

Some ofthese places, theyre 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. Its hard to be patient. I understand if youre miserable, if youre partially paralyzed or have debilitating arthritis or youve had COPD for 20 years and youre 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, its said, are hot-headed, intelligent, risk-taking.

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

From memory, he recitespatient 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 Alzheimers disease, brain injuries and bum knees. His wife benefited from stem cell injections in her hip, he said. Hes treated himself for sciatica.

The work, he says, fills him with an enthusiasm he hasnt experienced since his earliest days out of medical school. He sees himself as a pioneer in a field thats just blossoming, and will transform the practice of medicine.

Mark Berman is co-founder of California Stem Cell Treatment Center and the Cell Surgical Network. Scott Strazzante, The Chronicle

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 whats 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 patients 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.

A doctor at Health Link Medical Center in San Rafael holds syringes filled with stem cells. The stem cells, taken from a patients bone marrow, are ready to be re-injected into the patient. Gabrielle Lurie, The Chronicle

Paul Handleman (left) works with nurse Jessica Vanderbyl during a stem cell procedure at Health Link Medical Center. Health Link is part of Regenexx, a Colorado-based operation that specializes in using stem cells for orthopedic procedures. Gabrielle Lurie, The Chronicle

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

He and other for-profit providers say adult stem cells can home in on damaged parts of the bodyand 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 bodys own nerve cells, stem cells can help rebuild damaged cells and improve immune function, they say.

These claims if theres 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 wont target an injured area of the brain. They wont float around the body healing the immune system.

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To critics, Berman said, Were a bunch of quacks and scallywags ... were charlatans and taking advantage of people.

Thats ridiculous, he said. Why would I be doing this unless it was incredibly successful?

Critics point to one answer: money.

Procedures at Bermans clinics cost $8,900, though he said hell 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 hes convinced that what hes selling is already helping people. And if hes able to offer a treatment now, even if its imperfect, thats our moral duty, he said.

Were taking people with absolutely no chance, and were 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?

Nathan Newman examines patient Hersel Mikaelian in his Beverly Hills clinic. Newman, who specializes in using fat stem cells for cosmetic procedures, treated Mikaelian for facial disfigurement caused by cancer. Scott Strazzante, The Chronicle

The providers of consumer stem cell therapies operate largely in this latter domain. Its 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, theyre 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.

Hopedrove 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 thats 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 shed 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 didnt 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 wouldnt have to travel to another country.

But after her visit there in 2015, she didnt 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 werent worth the cost.

Shes 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 its 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. Shed been overly hopeful. Desperate.

It was a plastic surgeons office, Gwinn said. They were just taking out the cells and spinning them around and putting them right back in. What theyre doing for MS is not a darn thing.

Still, she says she doesnt 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 hasnt entirely given up on stem cells. They might help some people, someday just probably not her.

Stephen Derrington treats patient Shannon McCloud at Health Link Medical Center, a stem cell clinic in San Rafael. Gabrielle Lurie, The Chronicle

Others are far more critical of the clinics.

Some stem cell providers may truly believe theyre helping people, said David Spiegel, a Stanford psychiatrist who is chair of the universitys advisory panel that oversees its research involving stem cells. Most, though, are well aware that what theyre selling isnt real, he said.

The idea that its this magic cure is greatly exaggerated, Spiegel said. At the moment, most of it in clinical practice is snake oil. I dont have much of a sense of humor about these practitioners and companies that are fleecing people on false hope.

The "Torso" statue by Robert Graham stands at Rodeo Drive and Dayton Way, in the center of Beverly Hills shopping district. At least eight stem cell clinics are within walking distance of the art. Scott Strazzante, The Chronicle

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 injuryfor months, despite surgery and working with top physical therapists. In April, he had stem cells injected into the injury site. Doctors didnt 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 its 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 fathers 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.

Its 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.

Continued here:
Stem cell market: Inside California's flourishing for ...

FDA Wants To Tighten The Screws On Stem Cell Clinics …

By Emily Bazar September 12, 2016

The U.S. Food and Drug Administration is proposing to get tougher on clinics that offer unapproved stem cell therapies, and is hosting a critical public hearing on the issue Monday and Tuesday in Bethesda, Md.

A study published recently in the journal Cell Stem Cell found that 570 clinics across the country are offering pricey stem cell treatments for both cosmetic and medical purposes. The clinics claim to treat a wide variety of problems, from spinal cord injuries to autism.

Authors Leigh Turner of the University of Minnesota and Paul Knoepfler of the University of California, Davis identified 113 such clinics in California alone, the most of any state.

There are clear grounds for concern that some of the companies we found are not compliant with federal regulations, they wrote.

Many of these clinics say they use stem cells derived from patients own fat. They argue their treatments are exempt from the agencys rigorous approval process because the fat cells are minimally manipulated and shouldnt be classified as drugs subject to FDA regulation.

But late last year, the FDA sent a warning letter to a doctor saying that the processing of fat cells in his clinics, including one in California, would not meet the definition of minimal manipulation and his product was therefore considered a drug that required agency approval.

Nearly 100 stem cell clinics, doctors, researchers and organizations plan to testify at the hearing about these issues.

California Healthline interviewed three participants, with divergent views, all California-based experts whose professional lives revolve around stem cell science.

Jeanne Loring is a professor and stem cell researcher at The Scripps Research Institute in La Jolla. She supports tighter FDA controls.

Elliot Lander is co-medical director and co-founder of Cell Surgical Network, a Rancho Mirage, California-based group comprising about 100 stem cell clinics, most of them in the U.S. He is wary of the FDAs plan for more regulation.

C. Randal Mills is CEO of the California Institute for Regenerative Medicine, the states stem cell agency, based in Oakland. He calls for a middle ground between the FDAs strict approval process and total exemption from that process.

The transcript below has been edited for length and clarity.

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FDA Wants To Tighten The Screws On Stem Cell Clinics ...

Meet Our Doctors – Rejuva Stem Cell Clinic

Dr.KarenVieira has a Ph.D. in Biomedical Sciences from the Department of Biochemistry and Molecular Biology at the University Of Florida College Of Medicine, a Master of Science in Management and a Bachelor of Science in Molecular Biology. She has worked in hospitals and clinics conducting clinical research with patients, as well as in biotechnology laboratories, researching the biochemistry and molecular biology of the body, animals and even micro-organisms.This involved both mouse and human stem cell research.

Additionally, she worked in the food industry with the largest food company in America whereshe researched food and supplement ingredients for a variety of health conditions. While there, she also started a comprehensive cell culture research project, a first of its kind there, discovering and prioritizing novel and emerging food ingredients for health and wellness using cell culture studies.

Karenis the owner of The Med Writers, a company specializing in writing and consulting in the food, supplement, biotech, pharma and stem cellindustries.Her passion is discovering existing research on dietary and lifestyle changes, plus non-pharmaceutical and non-surgical methods,that prevent, cure or improve various health conditions. Not only does she have knowledge on healthy living, but she personally lives it, inspiring others to do the same.Having experienced the power of stem cell injections personally, she is an advocate for stem cells to boost health.

Most importantly, she has the rare ability to explain the findings of medical research studies in an easy-to-understand way so that anyone can instantly get it. Her knack for explaining things gives listeners and readers simple steps on how to apply and use the knowledge in their own life to improve their health. For these reasons and more, Dr. Vieira is currently a popular author, speaker and consultant in the health and wellness industry.

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Meet Our Doctors - Rejuva Stem Cell Clinic