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Stem cell therapy: FDA investigates clinics offering …

Stem Cell Clinics | Posted by admin
Jan 11 2019

Inside Mark Bermans clinic in Rancho Mirage, California, is a sign hes obliged by law to post. It reads Not FDA Approved.

Patients who come here to the California Stem Cell Treatment Center can get treatments for ailments ranging from sports injuries to muscular dystrophy. For upward of $5,000, Berman, a plastic surgeon by training, will remove a small portion of their fat, process it, and inject it back into them.

This is called fat-derived stem cell therapy; the premise is that the stem cells in your fat can jump-start the healing process. The stem cells could be good for repairing everything from Alzheimers to paralysis to neurodegenerative conditions, says Berman. These cells are miraculous for helping heal. We dont have a choice. We have to use them.

The problem is theres not much evidence to back up the claims Berman is making. And its not just him there are more than 100 clinicians in the Cell Surgical Network, a group he co-founded in 2010 to promote the same kind of adult stem cell regenerative medicine he practices. According to a 2017 report by three Food and Drug Administration scientists in the New England Journal of Medicine looking at the benefits and risks of this kind of stem cell therapy, This lack of evidence is worrisome.

Fat-derived stem cells may have a positive effect, says Brad Olwin, a professor of molecular cellular and developmental biology at the University of Colorado Boulder with more than 30 years of experience working with stem cells. They may be beneficial; its clearly a possibility. The problem is the research hasnt been done.

So little evidence exists, in fact, that the Department of Justice, on behalf of the FDA, is suing Bermans clinic as well as a clinic in Florida for experimenting on patients with misleading products. The complaint was filed in May 2018 and the investigation is ongoing, according to the DOJ.

Given the popularity and abundance of these clinics nationwide, the FDA is also taking steps to modernize regulation in the field. But despite these efforts to streamline a path to legitimacy for stem cell clinics, unregulated medical procedures persist, at times leading to patient harm.

Currently, the only stem cell therapies approved by the FDA use cells from bone marrow or cord blood to treat cancers of the blood and bone marrow.

But doctors in the Cell Surgical Network have moved ahead with using cells for autoimmune, neurologic, and other serious conditions.

And there is a growing number of cases of adverse effects. In 2016, an elderly woman went blind after receiving an injection of stem cells to treat her macular degeneration. She received the treatment at the Stem Cell Center of Georgia an affiliate of Bermans Cell Surgical Network.

More reports of ill-fated procedures have since surfaced across the country, the worst resulting in kidney failure and paraplegia. In December, the Centers for Disease Control and Prevention reported 12 cases of people who suffered bacterial infections from contaminated stem cell treatments. An investigation traced the infections back to a single provider, Genetech, prompting the FDA to issue a warning letter to the company. FDA Commissioner Scott Gottlieb then issued a public statement reaffirming the agencys intent to regulate unapproved treatments.

Bioethicists are sounding the alarm too. In a recent paper in the journal Perspectives in Biology and Medicine, the University of Minnesotas Leigh Turner examined the marketing claims of 716 stem cell clinics in the United States. Often, he found, they were misleading. What at first glance might appear to be credible and compliant clinical research often is highly problematic, he wrote, adding that the individuals most affected are those who often are already dealing with serious health problems and other challenges.

Despite two years of increased scrutiny from the FDA, clinics continue to recruit new patients. Berman insists that repurposed fat-derived stem cells should not be subject to the same regulations as other treatments, and that FDA guidelines are arbitrary and nonscientific. They are a violation of constitutional rights to your own property.

He noted that after the case of the woman with macular degeneration going blind, his networks clinicians no longer inject fat-derived stem cells into patients eyes. But they continue to offer intravenous (bloodstream) injections. We have virtually three or four adverse events, of very little significance or consequence, says Berman, referring to the patients in his network. But according to the FDA, intravenous injections are associated with higher risk.

Other scientists I spoke with say theyre also worried that intravenous treatments may harm patients. Youre taking cells out of one part of your body, and putting them into another. You have absolutely no control after that, says Olwin. He acknowledges the FDAs efforts to crack down on clinics but suggests that much more can be done. They have limited resources to go after people. But I think its irresponsible for doctors and these clinics to be promoting these things.

Some types of stem cells can indeed give rise to virtually any cell in the body providing a platform for regenerating muscle or even rebuilding organs. Stem cells derived from embryos have this power, called pluripotency, but those obtained from adults do not. In order to acquire pluripotency, adult stem cells must be biologically reprogrammed a feat that, when invented, led to a Nobel Prize. These induced pluripotent stem cells allow doctors to treat challenging illnesses such as leukemia.

But clinics like Bermans are not using pluripotent stem cells they are using the mesenchymal stem cells found in fat, which are much more limited in function. Arnold Caplan, the fields pioneer who first gave them the stem cell label, recently advocated for renaming them to prevent doctors from claiming that they can cure the blind, make the lame walk, and make old tissue young again.

BrainStorm, a biotechnology company working with mesenchymal cells, recently gained FDA approval to begin clinical trials to treat patients suffering from multiple sclerosis. But to treat the neurological condition, BrainStorm researchers have developed a method to convert the mesenchymal cells into biological factories that release disease-treating proteins. In other words, BrainStorms therapy doesnt involve mesenchymal cells doing the work on their own what some clinics in the Cell Surgical Network claim mesenchymal cells can do.

Outside of the Cell Surgical Network, other clinics are using patients fat-derived cells but making different claims about the treatment.

I dont say Im doing stem cell therapy, says Dr. Joanne Halbrecht, an orthopedic surgeon and founder of Boulder Regenerative Medicine. Her clinic uses patients fat-derived cells to treat orthopedic conditions, injecting them into joints.

Halbrecht avoids the stem cell label because current research does not support claims that these fat-derived cells can turn into cartilage. Instead, she uses patients fat to cushion their joints. According to Olwin and the FDA, such joint injections are significantly lower-risk than intravenous injections.

Berman also administers direct joint injections. But afterward, he tells me, his clinicians also inject the leftover cells into the patients bloodstream. Halbrecht is adamant that this kind of procedure is unproven and unsafe.

Thats definitive. Its not a question, she says. They are completely wrong because there is zero science behind that.

For clinics to prove the safety and efficacy of their fat-derived stem cell treatments to the FDA, they must run rigorous clinical trials.

But some clinicians argue that even if they were interested in clinical trials, getting the FDAs blessing is too daunting. Clinical trials span years and cost millions of dollars. For small, privately owned clinics, this process is unaffordable.

In response, the FDA unveiled a more feasible clinical trial process, better suited to small businesses. Clinics that want to test a specific treatment can now team up on clinical trials and pool their patients, which can save them time and money. Still, the FDA is offering a grace period of up to 36 months for clinics to comply with its guidelines, allowing many to continue operating on patients without doing clinical trials. In the meantime, the FDA is urging patients to do [their] part to stay safe, according to a consumer warning issued in May.

Unfortunately, thats not so easy. Whether or not a clinic is offering an FDA-compliant treatment can be unclear. Some doctors advertise compliance because the device they use to remove and process a patients fat is technically FDA-approved. But if they then advertise their treatment as an FDA-approved stem cell therapy, they risk misleading patients.

Berman has no plans to pursue clinical trials, even with the new streamlined process. He believes his current model of clinical experimentation is adequate. In the so-called safety studies, he treats paying patients with a wide variety of diseases. But according to the recent bioethics report, Turner found that these pay-to-participate studies are poorly designed and unscientific.

In Bermans view, more patients benefit by obtaining cutting-edge treatments faster. But for every revolutionary treatment developed in a lab, there are nine duds and many unpredictable dangers. And unsanctioned clinics cost patients thousands of dollars and are not covered by insurance. Critics argue that it is unethical to charge patients for experimental procedures, as sanctioned clinical trials rarely cost patients anything.

The economic incentives for unsanctioned stem cell clinics are clear. Starting clinical trials would not only reduce patient revenue but also commit clinics to a costly process known to last for years. Shifting blame to the government and research community, Berman assures me that he and his colleagues are not motivated by self-interest. Were the good guys, he says.

In March, the woman blinded by an unsanctioned stem cell treatment filed a lawsuit against Bermans Cell Surgical Network. Bermans site still advertises treatment for macular degeneration with a link to an application.

But tucked away on Bermans website sits a sort of confession that may surprise the many patients who hear him speak with unwavering assurance. The page reads, We do not claim that these treatments work for any listed nor unlisted condition, intended or implied.

Max Levy is a PhD student in chemical and biological engineering at the University of Colorado Boulder and the senior editor of Science Buffs, a graduate student science blog. He writes about health, medicine, and the environment.

Update, January 11: A reader pointed out that the FDA has also approved stem cell treatments from cord blood and so the post has been updated to reflect that.

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Stem cell therapy: FDA investigates clinics offering ...

Stem cell market: Inside California’s flourishing for …

Stem Cell Clinics | Posted by admin
Dec 24 2018

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 …

Stem Cell Clinics | Posted by admin
Dec 24 2018

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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Meet Our Doctors – Rejuva Stem Cell Clinic

Stem Cell Clinics | Posted by admin
Dec 24 2018

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

What Stem Cell Clinics Do You Trust? | BioInformant

Stem Cell Clinics | Posted by admin
Nov 05 2018

Stem cell clinics have received a great deal of negativepress,with prominent media outlets announcing that the FDA mailed Warning Letters to stem cell clinics across the United States.According to a paper published in the journalCell Stem Cell in June 2016,at least 351 businesses offer unproven stem cell interventions fromclinics spread across the U.S.

Shortly after publication, the MIT Technology Reviewand Washington Postpicked up the story, spreading the fear far and wide.Journalists then got enthralled with the story, calling it the Wild West of stem cells.

But, is this the whole story?

In this article:

What this hype does not cover isthe promising medical potentialof stem celltherapies, nor has it properly credited the clinics that comply with FDA regulations to offer effective medical treatments to populations of patients who, otherwise have limited options.

Today, the large majority of medical clinics that offer stem cell treatments administer mesenchymal stem cells (MSCs), which they source from fat (adipose tissue) orbone marrow.

Mesenchymal stem cells are a type of multipotent stem cell that is administered for a range of medical applications, including orthopedic repair, pain management, arthritis, asthma, and more.

When properly administered, multipotent self-derived stem cells (such as MSCs) can be safe for patient use.

It is important that the cells be multipotent (limited in their differentiation capacity), rather than totipotent (can become any cell) or pluripotent (can become most cells). There is also an additional level of safety that comes from having the stem cells be self-derived, which doctors and scientists call autologous.

Stem cell differentiation capacity is explained below:

While it is true that many stem cell clinics are not properly regulated, the therapeutic promise of stem cells is also clear.

Today, nearly 30,000 scientific publicationshighlight research and therapeutic advanceswith mesenchymal stem cells (MSCs) and approximately850+ clinical trials are investing therapeutic uses of MSCs.

Additionally, 300,000+ scientific publications about stem cells have been released.

This momentum is not surprising, because We are not made of drugs, we are made of cells.

However, the biggest issue with the hype surrounding stem cell clinics is that it does not give proper credit to the companies that cooperate with regulatory bodiesto ensure a safe and efficacious patient experience. Many of these companies also collaborate withoffshore regulatory bodies to offer stem cell procedures approved by local regulatory agencies.

The FDAsCenter for Biologics Evaluation and Research (CBER)regulates human cell and tissue-based products in the U.S., known as HCT/Ps. The FDA has two different paths for cell therapies based on relative risk.

These pathways are commonly called 361 and 351 products.

The 361 products that meet all the criteria in 21 CFR 1271.10(a)are regulated as HCT/Ps and are not required to be licensed or approved by the FDA. These products are called 361 products because they are regulated under Section 361 of the Public Health Service (PHS) Act.

In contrast, if a cell therapy product doesnot meet all the criteria outlined in 21 CFR 1271.10(a)), then it is regulated as a drug, device, or biological product under the Federal Food, Drug, and Cosmetic Act (FDCA) and Section 351 of the PHS Act.[1]

These 351 products requireclinical trials to demonstrate safety and efficacy in a process that is nearly identical to that what is required for pharmaceutical products to enter the marketplace.

Stem cell clinics must ensure that their treatments meet the FDAs criteria to be classified as 361 products.

Below, we cover five leading stem cell clinics. Each one has treated large populations of patients with adult stem cells. At least one (Regenexx), is maintaining a Patient Registry to document long-term patient outcomes.

We are not advising patients to seek treatments from these companies.We are identifying them to allow readers to seek out more information.

Founded by Dr. Neil Riordan, a globally recognized stem cell expert and visionary, the Stem Cell Institute in Panama is among the worlds leaders in stem cell research and therapy. Their treatments focus on well-targeted combinations of allogeneic umbilical cord stem cells, as well as autologous bone marrow stem cells.

The clinic uses stem cell therapies to treat various ailments, including spinal cord injury (SCI), rheumatoid arthritis, heart failure, osteoarthritis, multiple sclerosis, autoimmune diseases, and genetic disorders, such as autism and cerebral palsy.

One of their most recent studies exhibited the clinical feasibility of stem cell therapy as a safe and effective treatment approach for patients with multiple sclerosis (MS). Published in the Journal of Translational Medicine, the study showed that umbilical cord stem cells can slow down MS disease progression and decrease the frequency of flare-ups.

However, these stem cells did not exhibit the ability to repair damaged nerve cells or myelin sheaths.

After the completion of this clinical study, there was an improvement in MS patient disability. The 1-month mark of the study documented improvements in mobility, hand, bladder, bowel, and sexual functions. Importantly, the study demonstrated that a sustained one-year umbilical cord stem cell therapy has more durable benefits than current MS drug therapies.

Headquartered in Denver, CO, Regenexx offers self-derived (autologous) same-day stem cell treatments to patients with orthopedic injuries and conditions. Regenexx clinicsincorporate a variety of regenerative approaches, drawing patients from all over the U.S. who are seeking innovative, non-surgical treatments.

TheRegenexx technologyinvolvesa procedure in whicha small bone marrow sample is extracted through a needle and a blood is drawn from a vein in the arm. These samples are then processed in a laboratory and the cells it contains injected into the area needing repair, with the goal of delivering large numbers of stem cells to the site of injury.

Regenexx also a licensedoffshore clinic in the Cayman Islands where patients can undergo treatments that utilize laboratory expanded (ex vivo) stem cell populations. This approach allows for a much larger number of stem cells to be administered to the patient that is supported by U.S. law, which currently prohibits laboratory procedures that the FDA considers to exceed minimal manipulation.

Dr. Christopher Centeno is the Founder and CEO of Regenexx. He is a global authority in the culture expansion and clinical use of adult stem cells to treat orthopedic injuries and thevisionary behind the Regenexx technology.

I am also a Regenexx patient.Click here to read my experience.

Founded in 2011,Okyanosis a stem cell therapy provider that specializes in treating patients with congestive heart failure (CHF) and other chronic degenerative conditions. Okyanos Cell Therapy uses internationally-approved technology to deliver a mixed population of fat (adipose) derived stem and regenerative cells (ADRCs) to patients with conditions such as cardiovascular disease, orthopedic issues, neurological disorders, urological indications, and autoimmune conditions.

Okyanos maintains both a North American Office in Clearwater, FLand a purpose-built Cell Therapy Surgical Center inFreeport, GrandBahama. Okyanos stem cell treatments are performed in their state-of-the-art surgical centers under the care of board-certified doctors.

Okyanos is also fully licensed and regulated under the Bahamas Stem Cell Therapy and Research Act, and adheres to U.S. surgical center standards.

Click here to access our recent interview withMatthew Feshbach, Co-Founder and CEO of Okyanos.

The Global Institute of Stem Cell Therapy and Research (GIOSTAR) provides adult stem cell for autologous and allogeneic stem cell therapy to patients around the world, based on research byDr. Anand Srivastava. It offers adult stem cells for rejuvenation treatment, muscular injuries and degenerative diseases.

Each of GIOSTARs clinics is licensed for the application of stem cell therapy.Since 2000, its team of scientist and clinicians have been involved in the development and utilization of stem cell-based clinical protocols for stem cell therapy.

Although the company is headquartered in San Diego, California, GIOSTAR Mexico has provided stem cell therapy to patients from all over the world. Mexicos regulation of stem cell therapeutics differs from the regulations imposed by the U.S. FDA, making it a growing site for medical tourism.

Celltex specializes in cryopreserving mesenchymal stem cells (MSCs) for therapeutic use. Celltex acquires stem cells by collecting a small fat sample from a patient, from which MSCs are extracted,isolated, multiplied and stored for future use (known as cell banking).

Patients can then use their stored stem cells for regenerative purposesthrough infusions or injections performed by a licensed physician.

Because the FDA considers an individuals stem cells a drug if they have been expanded in large quantities, Celltex has begun the process of undertaking clinical trialsin which itwill seek approval from the FDA to provide stem cells for use by physicians in the U.S. to treat a variety ofmedical conditions.

Nonetheless, to meet the immediate needs of its clients, Celltex has takensteps to comply with the regulations established by the FDA and COFEPRIS, the Mexican equivalent of the FDA for exporting and importing MSCs.

Celltex also works with established, certified hospitals in Mexico, where independent, licensed physicians make it possible for Celltexs cell-banking clients to receive their own cells for therapeutic purposes.

While the information above is important to understand from a scientific and regulatory perspective, patient experiences are valuable too.

Have you had a stem cell treatment? What stem cell clinic did you use? What treatment did you get and for what condition?

Share your answers in the comments below, so that other patients can make more informed decisions.

BioInformant is the first and only market research firm to specialize in the stem cell industry. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Xconomy, and Vogue Magazine. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs. BioInformant is your global leader in stem cell industry data.

Footnotes [1] Aabb.org. (2017). Cellular Therapies. [online] Available at: http://www.aabb.org/advocacy/regulatorygovernment/ct/Pages/default.aspx [Accessed 1 Aug. 2017].

What Stem Cell Clinics Do You Trust?

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What Stem Cell Clinics Do You Trust? | BioInformant

Stem cell laws – Wikipedia

Stem Cell Clinics | Posted by admin
Oct 17 2018

Stem cell laws are the law rules, and policy governance concerning the sources, research, and uses in treatment of stem cells in humans. These laws have been the source of much controversy and vary significantly by country.[1] In the European Union, stem cell research using the human embryo is permitted in Sweden, Spain, Finland, Belgium, Greece, Britain, Denmark and the Netherlands;[2] however, it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving support.[3] Elsewhere, Japan, India, Iran, Israel, South Korea, China, and Australia are supportive. However, New Zealand, most of Africa (except South Africa), and most of South America (except Brazil) are restrictive.

The information presented here covers the legal implications of embryonic stem cells (ES), rather than induced pluripotent stem cells (iPSCs). The laws surrounding the two differ because while both have similar capacities in differentiation, their modes of derivation are not. While embryonic stem cells are taken from embryoblasts, induced pluripotent stem cells are undifferentiated from somatic adult cells.[4]

Stem cells are cells found in most, if not all, multi-cellular organisms. A common example of a stem cell is the hematopoietic stem cell (HSC) which are multipotent stem cells that give rise to cells of the blood lineage. In contrast to multipotent stem cells, embryonic stem cells are pluripotent and are thought to be able to give rise to all cells of the body. Embryonic stem cells were isolated in mice in 1981, and in humans in 1998.[5]

Stem cell treatments are a type of cell therapy that introduce new cells into adult bodies for possible treatment of cancer, somatic cell nuclear transfer, diabetes, and other medical conditions. Cloning also might be done with stem cells. Stem cells have been used to repair tissue damaged by disease.[6]

Because Embryonic Stem (ES) cells are cultured from the embryoblast 45 days after fertilization, harvesting them is most often done from donated embryos from in vitro fertilization (IVF) clinics. In January 2007, researchers at Wake Forest University reported that "stem cells drawn from amniotic fluid donated by pregnant women hold much of the same promise as embryonic stem cells."[5]

The European Union has yet to issue consistent regulations with respect to stem cell research in member states. Whereas Germany, Austria, Italy, Finland, Ireland, Portugal and the Netherlands prohibit or severely restrict the use of embryonic stem cells, Greece, Sweden, Spain and the United Kingdom have created the legal basis to support this research.[7]Belgium bans reproductive cloning but allows therapeutic cloning of embryos.[1]France prohibits reproductive cloning and embryo creation for research purposes, but enacted laws (with a sunset provision expiring in 2009) to allow scientists to conduct stem cell research on imported a large amount of embryos from in vitro fertilization treatments.[1]Germany has restrictive policies for stem cell research, but a 2008 law authorizes "the use of imported stem cell lines produced before May 1, 2007."[1]Italy has a 2004 law that forbids all sperm or egg donations and the freezing of embryos, but allows, in effect, using existing stem cell lines that have been imported.[1]Sweden forbids reproductive cloning, but allows therapeutic cloning and authorized a stem cell bank.[1][7]

According to modern stem cell researchers, Spain is one of the leaders in stem cell research and currently has one of the most progressive legislations worldwide with respect to hESC research.[8] The new Spanish law allows existing frozen embryos - of which there are estimated to be tens of thousands in Spain - to be kept for patient's future use, donated for another infertile couple, or used in research.[9] In 2003, Spain's laws state that embryos left over from IVF and donated by the couple that created them can be used in research, including ES cell research, if they have been frozen for more than five years.[10]

In 2001, the British Parliament amended the Human Fertilisation and Embryology Act 1990 (since amended by the Human Fertilisation and Embryology Act 2008) to permit the destruction of embryos for hESC harvests but only if the research satisfies one of the following requirements:

The United Kingdom is one of the leaders in stem cell research, in the opinion of Lord Sainsbury, Science and Innovation Minister for the UK.[11] A new 10 million stem cell research centre has been announced at the University of Cambridge.[12]

The primary legislation in South Africa that deals with embryo research is the Human Tissue Act, which is set to be replaced by Chapter 8 of the National Health Act. The NHA Chapter 8 has been enacted by parliament, but not yet signed into force by the president. The process of finalising these regulations is still underway. The NHA Chapter 8 allows the Minister of Health to give permission for research on embryos not older than 14 days. The legislation on embryo research is complemented by the South African Medical Research Council's Ethics Guidelines. These Guidelines advise against the creation of embryos for the sole purpose of research. In the case of Christian Lawyers Association of South Africa & others v Minister of Health & others[13] the court ruled that the Bill of Rights is not applicable to the unborn. It has therefore been argued based on constitutional grounds (the right to human dignity, and the right to freedom of scientific research) that the above limitations on embryo research are overly inhibitive of the autonomy of scientists, and hence unconstitutional.[14]

China prohibits human reproductive cloning but allows the creation of human embryos for research and therapeutic purposes.[1]India banned in 2004 reproductive cloning, permitted therapeutic cloning.[1] In 2004, Japans Council for Science and Technology Policy voted to allow scientists to conduct stem cell research for therapeutic purposes, though formal guidelines have yet to be released.[1] The South Korean government promotes therapeutic cloning, but forbids cloning.[1] The Philippines prohibits human embryonic and aborted human fetal stem cells and their derivatives for human treatment and research. In 1999, Israel passed legislation banning reproductive, but not therapeutic, cloning.[1][7]Saudi Arabia religious officials issued a decree that sanctions the use of embryos for therapeutic and research purposes.[1] According to the Royan Institute for Reproductive Biomedicine, Iran has some of the most liberal laws on stem cell research and cloning.[15][16] Laws and regulations in Jordan allow stem-cell research.[17] A center for stem cell research has acquired a license to begin operating in April 2017 at the University of Jordan.[18]

Brazil has passed legislation to permit stem cell research using excess in vitro fertilized embryos that have been frozen for at least three years.[1]

Federal law places restrictions on funding and use of hES cells through amendments to the budget bill.[19] In 2001, George W. Bush implemented a policy limiting the number of stem cell lines that could be used for research.[5] There were some state laws concerning stem cells that were passed in the mid-2000s. New Jersey's 2004 S1909/A2840 specifically permitted human cloning for the purpose of developing and harvesting human stem cells, and Missouri's 2006 Amendment Two legalized certain forms of embryonic stem cell research in the state. On the other hand, Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota passed laws to prohibit the creation or destruction of human embryos for medical research.[19]

During Bush's second term, in July 2006, he used his first Presidential veto on the Stem Cell Research Enhancement Act. The Stem Cell Research Enhancement Act was the name of two similar bills, and both were vetoed by President George W. Bush and were not enacted into law. New Jersey congressman Chris Smith wrote a Stem Cell Therapeutic and Research Act of 2005, which made some narrow exceptions, and was signed into law by President George W. Bush.

In November 2004, California voters approved Proposition 71, creating a US$3 billion state taxpayer-funded institute for stem cell research, the California Institute for Regenerative Medicine. It hopes to provide $300 million a year.

Barack Obama removed the restriction of federal funding passed by Bush in 2001, which only allowed funding on the 21 cell lines already created. However, the Dickey Amendment to the budget, The Omnibus Appropriations Act of 2009, still bans federal funding of creating new cell lines. In other words, the federal government will now fund research which uses the hundreds of more lines created by public and private funds.[20]

In March 2002, the Canadian Institutes of Health Research announced the first ever guidelines for human pluripotent stem cell research in Canada. The federal granting agencies, CIHR, Natural Sciences and Engineering Research Council, and Social Sciences and Humanities Research Council of Canada teamed up and agreed that no research with human IPSCs would be funded without review and approval from the Stem Cell Oversight Committee (SCOC).[21]

In March 2004, Canadian parliament enacted the Assisted Human Reproduction Act (AHRA), modeled on the United Kingdoms Human Fertilization and Embryology Act of 1990. Highlights of the act include prohibitions against the creation of embryos for research purposes and the criminalization of commercial transactions in human reproductive tissues.[22]

In 2005, Canada enacted a law permitting research on discarded embryos from in vitro fertilization procedures. However, it prohibits the creation of human embryos for research.[1]

On June 30, 2010, The Updated Guidelines for Human Pluripotent Stem Cell Research outline that:

Canada's National Embryonic Stem Cell Registry:

Australia is partially supportive (exempting reproductive cloning yet allowing research on embryonic stem cells that are derived from the process of IVF). New Zealand, however, restricts stem cell research.[23]

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Stem cell laws - Wikipedia

FDA: Florida Stem Cell Clinic Violates Law | Health News Florida

Stem Cell Clinics | Posted by admin
Sep 15 2018

A South Florida clinic that promotes controversial stem-cell treatments for a wide range of ailments is among the centers receiving a written warning that it is violating federal public health laws.

The U.S Food and Drug Administrations letter was addressed to Dr. Thomas A. Gionis, owner and chief surgeon of the Miami Stem Cell Treatment Center located in Boca Raton. Gionis also owns a stem cell treatment center in Irvine, Calif.

The letter shows that a third Gionis clinic in New York City apparently closed after FDA inspections of all three clinics was carried out from July through September 2015.

Dr. Gionis facilities are among more than 170 clinics across the country that are selling experimental stem cell procedures for dozens of diseases and conditions a mushrooming industry that has flourished despite little evidence of its safety or effectiveness.

Descriptions on the website say that Dr. Gionis and other practitioners inject or infuse a liquid that is said to contain stem cells derived from the patients own fat tissue, removed through liposuction. The clinic lists a large number of illnesses for which it says the treatments are appropriate, including: heart and lung disease, stroke, multiple sclerosis, spinal disc disease and auto-immune problems like lupus.

And his clinics are not the only ones operating in Florida. Internet search indicates this type of stem-cell treatment is available at clinics in Jacksonville, Orlando, St. Petersburg, Sunrise and a number of other sites throughout the state.

The rise of the U.S. stem cell industry illustrates how quickly fringe medicine can outpace government oversight. Over the last five years, academic stem cell researchers say they have watched in dismay as doctors treat patients with experimental techniques that they say could take years, if not decades, to become sound medicine.

"It's sort of this 21st century cutting-edge technology. But the way it's being implemented at these clinics and how it's regulated is more like the 19th century. It's a Wild West," says Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis.

The FDA letter to Dr. Gionis, dated Dec. 30, provides some insight into how the FDA is addressing the issue. In difficult-to-parse language, it says that the substance that Gionis is processing and injecting amounts to a drug that has not been approved for safety and usefulness.

The writer, Mary Malarkey, director of an office in the FDAs Center for Biologics and Research, says that if Gionis maintains his treatments are part of a clinical trial, as his website suggests, he would need to submit an Investigational New Drug (IND) application to FDA.

The FDA official says an earlier defense by the clinic that the chemical used in the mixture has been changed doesnt make it acceptable without more information.

Health News Florida was not able to reach Dr. Gionis on Monday, but left a message with his staff.

The Associated Press reported last May that entrepreneurial ventures using fat-derived stem cells have proliferated throughout the country. Scientists engaged in authorized stem-cell research said states have not stepped up to regulate the ventures and called on FDA to do so.

The FDA has scheduled a public hearing for April on draft guidelines for fat-derived stem-cell treatments that the agency released a few months ago. That led some to mistakenly think the treatments are being subjected to new regulations, said FDA spokeswoman Sarah Peddicord. She said the regulations went into effect in 2005.

The law has not changed, she said. What the agency released are guidelines that FDA hopes will help the industry and the public understand the law.

People need to understand how to implement the regulations, she said. The guidelines are just to explain the regulations.

Stem cells have long been recognized for their ability to reproduce and regenerate tissue. And while there are high hopes that they will someday be used to treat a range of debilitating diseases, critics say stem cell entrepreneurs have little more than anecdotes to support their offerings.

In 2010, there were only a handful of doctors promoting stem cell procedures in the U.S., mainly plastic surgeons promoting "stem cell facelifts" and other cosmetic procedures. But today there are clinics throughout the country promoting stem cells for dozens of conditions and diseases, including Alzheimer's, arthritis, erectile dysfunction and hair loss. The cost of these procedures is high, ranging from $5,000 to $20,000.

Many of the businesses are linked in large, for-profit chains which offer doctors the chance to join the franchise after taking a seminar and buying some equipment.

The largest of these chains is the Cell Surgical Network, co-founded in 2012 by Dr. Mark Berman, who spent 30 years as a Beverly Hills plastic surgeon before working with stem cells. His company offers stem cell procedures for more than 30 diseases and conditions, including Lou Gehrig's disease, multiple sclerosis and arthritis.

He and his partner adapted technology from Asia into a liposuction-based procedure in which fat is pumped out of patients' abdomen, processed with drugs and equipment and then injected back into the body.

Berman says this fat-based "soup," is rich in shape-shifting stem cells that have the potential to treat everything from neurological diseases to achy joints.

"I don't even know what's in the soup," says Berman. "Most of the time, if stem cells are in the soup, then the patient's got a good chance of getting better."

The clinics insist that their treatments are safe, but routinely require that patients sign waivers.

Patients of Dr. Zannos Grekos, a Florida cardiologist specializing in stem cell therapy, were also required to sign a consent form, acknowledging the procedures' risks, including death.

But families of two Grekos patients who died under his care say he downplayed the risks. Gina Adams, daughter of patient Richard Poling, says her family was told her father would be "back on the golf course the next day" after a procedure intended to treat a lung condition that made breathing difficult. The cost was $8,000.

In March 2012, Grekos harvested fat from Poling's abdomen and sent it to an off-site processing facility to isolate the stem cells. Later that afternoon, he directed an assistant to infuse the resulting mixture into the patient's bloodstream.

Poling suffered cardiac arrest and was pronounced dead after being rushed to a local hospital.

Two years earlier, in 2010, 69-year old Domenica Fitzgerald suffered a stroke after Grekos infused unfiltered bone marrow-derived stem cells into the arteries of her brain. The state report concluded "it was virtually inevitable that the procedure would clog blood vessels in the brain and cause a major and very possibly fatal stroke." Fitzgerald suffered severe brain damage and was removed from life support several days later.

Jack Fitzgerald says his wife, who used a wheel chair, had hoped that stem cells might help her walk again.

Not until 2013, after Poling's death, did the Florida Board of Medicine vote to revoke Grekos' license.

Though barred from practicing medicine in Florida, Grekos continues to treat patients in the Dominican Republican through his company Regenocyte, which promotes treatments for autism, dementia and many other diseases.

He believes the two deaths were unrelated to his care the state targeted him to discourage other doctors from working with stem cells, he says.

State actions against stem cell doctors are rare. That's led industry critics to conclude that regulation must come from the FDA, which regulates medical products on a national level.

But the FDA's authority to regulate stem cell procedures is not clearly defined and has been debated by legal experts for years.

Now, the FDA appears to be stepping up its oversight. In the last days of 2014, it released draft guidelines dealing with the popular fat-based stem cell technique. The agency said that processing fat to extract stem cells for medical use essentially creates a new drug, which cannot be sold in the U.S. without the agency's approval.

But many stem cell doctors continue to argue that they don't need FDA permission because they are not creating drugs, but performing in-office surgical procedures.

For now, Berman says he has no plans to change his business.

"How is it unethical if you're actually helping people, even if we don't have evidence-based studies to prove it?" he asks.

Carol Gentry is a special correspondent for WUSF in Tampa. Health News Florida receives support from the Corporation for Public Broadcasting.

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FDA: Florida Stem Cell Clinic Violates Law | Health News Florida

Patients guide to treatments – The Niche

Stem Cell Clinics | Posted by admin
Jul 14 2018

Updated for 2016. Top 10 list of important, easy to understand facts for patients about stem cell clinic treatments.

For better or worse, I am in the unique position of being a stem cell scientist and also a former cancer patient. Looking on the bright side this gives me a unique perspective on things compared to many of my colleagues.

I know there are thousands of people out there looking for more practical information about stem cell therapies and treatments. These folks understandably are using the Internet to look for some clear, good info on stem cell treatments either for themselves or their loved ones. Too often the info that is out there is either wrong, partially misleading, biased, or overly complex.

So in this post I want to address this need for trustworthy factual information and no-nonsense perspectives. I am speaking as a scientist, patient advocate and cancer survivor in the form of 10 key realties list belowto help you guide your way through the jungle of stuff out there about stem cells. As mentioned above, I have now updated this post for 2016 as some things have changed in big waysin just the past few years.Keep in mind this is not medical advice and you should absolutely talk to your personal doctor with whom you should make your own decisions.

1) Stem cells are often essentially a type of drug and possibly permanent in your body after a transplant.Yeah, stem cells can be extremely unusual drugs, but they are often drugs even if some argue they arent. The FDA considers them drugs in many cases. Unlike other drugs, once a patient receives a stem cell drug, it will not necessarily simply go away like other drugs because a stem cell drug consists of living cells that often behave in unpredictable ways. What this means is if the stem cells are doing bad things your doctor has no way to stop it. You have no way to stop it. Also because stem cells are alive they can grow inside your body, move around, and change. This can be helpful or harmful, but the big point is that it is not something that is controllable or reversible.

2) Side effects.Like any medical product, even aspirin,stem cells treatments will have side effects. Not maybe. Definitely. Our hope is the side effects will be relatively mild. Different kinds of stem cells have variable risk profiles, but if someone tells you that the stem cell treatment they are selling has no risks then that is a big red flag and I would walk away. They are either woefully lacking in knowledge or arent being honest with you. Sometimes clinics will either on their websites or in person acknowledge risks almost as sort of a disclaimer, but then theyll tell more casually that there arent really any risks. A common statement is The only risk is that it wont work. Thats false.

3)The only stem cell treatment explicitly approved by the FDA for use in the U.S. consists of versions of bone marrow/hematopoietic stem cell transplantation.What this means is that any other stem cell treatment you see advertised on Facebook or Google or elsewhere that indicates it will be given to you inside the U.S. is not FDA approved. The exceptions to this are if it is part of an FDA-approved clinical trial or it is using stem cells in a procedure that meets other criteria (e.g. being both homologous use and minimally manipulatedyeah I know these are jargon terms).

4)If you venture outside the U.S. for a stem cell treatment, use extra caution, but in 2016 also be very careful inside the U.S.Whether you travel abroad or closer to home, have a knowledgeable physician inside the U.S. guiding you, preferably your primary care doctor who mot often are not going to buy into hype. We have to avoid the trap of thinking that only the U.S. can offer advanced medical treatments and these days many American patients get their stem cell transplants here in the U.S. from dubious clinics.

5)Stem cells are not a cure-all.I am as excited as anybody about the potential of stem cells to treat a whole bunch of diseases and injuries, but they are not some kind of miracle cure for everything. When a doctor offers to inject some kind of stem cells into a patient either into the bloodstream or into a specific place that is injured such as a shoulder, we just do not know at this point if it will do any good with the exception of bone marrow transplant. You should start getting worried if the clinic tells you that one kind of stem cell such as fat, bone marrow, or amniotic stem cells can treat many different conditions. Theres no science behind that kind of claim. Stem cells are not a panacea.

Patients often mention to me that the doctors offering stem cell treatments told them that the treatments are proven safe.or that your own stem cells cannot harm youor that adult stem cells are harmless. I often tell people to think about how much research and how many questions they ask when looking to get a new car. You should bring at least that level of intensity (ideally much more) to getting info about stem cell transplants too as the stakes are even higher.Be skeptical. Ask many questions and if you arent convinced, then dont do it.

6)Dont let celebrities be your guide to medical care.The number of famous people getting stem cell treatments is increasing including sports stars and politicians. Dont let what these folks do influence what you decide to do about your health. Just because they are famous do not believe for one minute that they are any more informed than you or your personal doctor about medical treatments or stem cells. If anything I think sometimes famous people are more reckless with their health than average people like you and me.

7)Reach out to scientists as a source of info.As a scientist I am always happy to hear from people outside the scientific community with questions about stem cells and other research. I cant speak for all stem cell scientists but you might be surprised at how likely it is that if you send them a very short, clear email with one or two questions that they will respond and be helpful. We cant or shouldnt offer medical advice, but we can give our perspectives on stem cell research and its clinical potential, etc. Just do not cold call scientists as you are unlikely to find them that way and even if you do, they may be cranky. Email. If they dont reply try someone else and dont be offended they we didnt answer. Often times we may not answer because we are super busy. For instance, I often get more than 100 emails a day.

8)The people selling you non-FDA approved stem cell treatments want your money.As such they will do their best to convince you that their treatment is safe and effective. The more convincing they are then the more money they make. They may offer patient testimonials either from patients who truly believe they were helped or from people who are paid to say the treatment helped them. The bottom line is that the sellers of dubious stem cell treatments are generally in it for the big bucks. Admittedly I do think that some of these providers truly believe stem cells are helpful, but youll never see even them offering to give patients the cells at cost. These are instead very much for-profit operations.

9)NEWJust because something is called a stem cell clinical trial doesnt mean it really is and being listed on clinicaltrials.gov means a lot less than it used to.I am contacted weekly or even daily at times by patients or their families and they are rightly focused on getting information that they can trust. Many stem cell clinics call the treatments that they offer by the name clinical trial and thats often misleading. In the standard meaning of clinical trial the experimental therapy being tested has the FDAs approval to be used in the study, there are data supporting the study, and those doing the trial do not charge patients to be in it. You shouldnt have to pay to be a guinea pig. I think thats almost always going to be unethical on the part of those giving it. I often suggest that people turn to the federal website clinicaltrials.gov for information and that is still a great resource, but be aware that many pseudo-clinical trials are popping up on there that are really mostly about making money. They do not have FDA approval in many cases and there are other issues of concern. So even on that website use caution.

10)The most important thing is information/data and you have a right to see it before treatment.Before you or a loved one get a stem cell treatment, ask two key questions. First, is the treatment FDA approved and if not, why not? Second, can you please show me the data that proves your treatment is safe and effective? See what kind of answer you get. If they criticize the FDA or invoke a plot by big pharma to block stem cells then that is a warning flag. If they refuse to show you data, then that is a big red warning flag. They may say it is confidential or that it is not published yet, but as a patient you have a right to see the data, assuming they have any data at all.

These facts will likely change over the coming years, but right now I think they represent reality. I know as patients we need hope, but these unapproved stem cell treatments will at best take your money for nothing, and at worst will endanger you or your loved ones.

The post above is for information only and is not medical advice. All medical decisions should be made by patients in consultation with their personal physicians.

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Patients guide to treatments - The Niche

Adult Stem Cell Therapy in Utah Docere Clinics

Stem Cell Clinics | Posted by admin
Oct 18 2017

Stem cells, specifically mesenchymal stem cells (MSCs), have been called patient-specific drug stores for injured tissues because of their broad range of healing abilities. MSCs are directly responsible for healing damaged tissues after injury. Upon encountering damaged tissue, they release proteins that decrease inflammation, kill invading microbes, and trigger the growth of new connective tissues and blood vessels.In the case of severe damage and cell death, MSCs have the ability to turn into healthy versions of damaged or destroyed cells that they encounter.

When we take MSCs from your own bone marrow, from your own fat, or from both, concentrate and/or isolate them, and then inject them directly into your problem area, we trick your body into thinking that there has been a new injury without actually causing any tissue insult, and you get a second chance at healing. In the case of advanced osteoarthritis where the population of stem cells has been depleted, we are repopulating the area with stem cells, and thereby restoring the bodys natural ability to heal itself.

Docere Clinics is an affiliate member of the Cell Surgical Network(CSN).It is the belief of the CSN that the most ethical approach to stem cell therapy is under the umbrella of IRB approved research protocols. An IRB is an Institutional Review Board;a committee responsible for approving and overseeing research on humans. IRBs are approved under the auspices of the U.S. Department of Human Research Protection. As such, our patients understand the investigational nature of our activities, are provided appropriate informed consents, and are followed continuously on an online database to chart their progress or any issues of concern. The efforts of the CSN will provide safety data,demonstrate effectiveness of treatments, and help to improve treatment programs going forward.

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Adult Stem Cell Therapy in Utah Docere Clinics

At ClinicalTrials.Gov, Untested Stem Cell Clinics …

Stem Cell Clinics | Posted by admin
Oct 13 2017

Stem cell cultures growing in multi well sample tray.

Andrew Brookes/Getty Images

Macular degeneration is the most common cause of vision loss among the elderly. But for some people with the disease, a shot of stem cells to the peeper was all they needed to see again . For others, treatment left them permanently blind . What gives? Stem cell treatments like the one described abovehappening every day in 600 clinics across the USare not approved by the FDA, and in fact have never been tested in a clinical trial.

Eyes arent the only organ getting stabbed full of stem cells. Around the country, more doctors are marketing the therapy to treat everything from diabetes to asthma to erectile dysfunction. The procedure usually involves sucking out some of a patient's fat tissue with a liposuction needle, isolating their stem cells, and reinjecting them back into the place in their body that needs most healing. But because these are living tissues unique to every individual, results may vary. Advocates of the therapy say thats just the cost of doing cutting-edge medicine. Except, any proof they have that it is effective comes from data collected on patients who pay thousands of dollars for the treatment. Usually people pay money for medicine after theres proof it works. In the last few years, some of these stem cell clinicians have begun posting large-scale studies on a government-run website called ClinicalTrials.gov, even though they're often not up to medical research standards or even in compliance with federal regulations. This allows them to masquerade their pay-to-participate studies as legit science.

According to a paper published today by the University of Minnesota, US companies have successfully registered 18 patient-sponsored stem cell studies on that publicly funded website. Only 7 of them disclose that patients pay their own way. None of them list the costs, which can range from $5,000 to $15,000 a treatment, outright. And none of them are actual clinical trials in the randomized, blinded, gold-standard sense of the phrase. Instead, theyre observational studies, based mostly on quality of life questionnaires that ask if youve had any adverse reactions to the procedure.

Leigh Turner, the bioethicist who penned todays perspective and who has become somewhat of a watchdog in the ballooning stem cell clinic industry, says this amounts to hijacking a public good and repurposing it into a free marketing tool. They dont have to pay for ads on television, people just come to them because its this trusted national resource, he says. Its all meant to suggest a seal of approval from the federal government. And thats whats so dangerously misleading, because it doesnt mean that all. It just means someone filled out a form and pressed a button.

Following the passing of the Food and Drug Administration Modernization Act of 1997, the National Library of Medicine established ClinicalTrials.gov to serve as a source of information about publicly and privately supported clinical trials for patients, their families and caregivers, doctors and nurses, and the public. But the NIH doesnt independently verify the scientific validity of any trials posted to the site beyond a limited quality control review. That doesnt really include things like sound study design, compliance with current regulations, or ethical guidelines. In fact, the process is largely automated, and relies almost entirely on the honor system.

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NIH said in a statement that it is continuing to evaluate ways to improve its outreach to make sure that trial participants understand potential risks and benefits. That included adding a prominent disclaimer on the ClinicalTrials.gov homepage in March 2017, stating: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study.

But that hasnt stopped stem cell therapy slingers from touting their clinical bonafides. Cell Surgical Network, an umbrella organization for more than 50 clinics that market the treatment directly to consumers, first registered on ClinicalTrials.gov in October of 2013. At the time, the organization put out a press release noting that the NIH had registered its approved safety study, and that it was now cleared to enroll 3,000 people to study the adverse effects of stem cell treatments on arthritis, cardiomyopathy, Parkinsons, ALS, and a host of other inflammatory and neurological diseases. The ClinicalTrials.gov listing of this study does not mention that research subjects are charged an average of $6000 to participate.

Elliot Lander, a urologist and co-founder of Cell Surgical Network says those costs are necessary because stem cell therapies dont make money like pharmaceuticals dothey can't be packaged up and mass-produced. Which means pharma companies and research institutions arent interested in footing the bill for clinical trials. And he says that while it might be worth noting the costs upfront, the NIH doesnt have a mandatory policy about including fees. Stem cell treatments have no business model, he says. So its left to physicians like myself to do the right thing by my patients, and get them regenerative medicine now, not 10-15 years from now. People dont need to be protected by Leigh Turner, they can do their own due diligence.

So far, at least 6,000 people have followed their due diligence to a treatment at one of Cell Surgical Networks clinics. The network keeps a database of all its patients and their outcomes, hoping for the day when the FDA decides to go from merely ignoring the proliferation of un-approved treatments to giving them a green light based on post-market data (a regulatory middle path floated by advocates like Lander.) In the meantime though, Cell Surgical Network is working with the FDA on an application for a real clinical trial, limited to just knee pain treatmentsthat will even include a randomized placebo. Its going to take us years and a few million dollars, says Lander. The walls are really high for this kind of thing. As they should be.

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At ClinicalTrials.Gov, Untested Stem Cell Clinics ...