A Stem Cell "Nose Job" and Updates on Regulation of Questionable Stem Cell Clinics

Tracking the latest on dubious stem cell clinics, the feds and the implications across the nation can be a bit of consuming task, if you are interested in that sort of thing.

But one Internet site does a pretty good job of keeping up with it. Here is what popped up last week on The Niche, which is based out of UC Davis.

•  A Q&A with a Georgia law professor concerning the federal crackdown on unregulated stem cell clinics. 
• A quick look at activities regarding the state of Washington's new law on stem cell clinics, the failed state regulatory attempt in the stem cell "hot bed" that is Florida plus questions about enforcement of California's new stem cell clinic law. 
• A video of a presentation by an unregulated stem cell clinic which discussed a product described as a  "magic concoction" that is sprayed up the patient's nose.  

Paul Knoepfler is the UC Davis stem cell researcher who produces The Niche and has long written about the dubious clinics that have proliferated across the nation, with the most in California. 

Feds Crack Down on Unregulated 'Stem Cell' Clinics, Including One in California

The Food and Drug Administration has moved to shut down two businesses that offer "stem cell" treatments, including one operation based in California,  following reports that some patients were blinded by treatments.

The lawsuits yesterday were characterized as "historic" by one California stem cell researcher, who has been reporting on unregulated and unproven "stem cell" treatments for several years. 

The firms involved are U.S. Stem Cell in Florida and California Stem Cell Treatment Center and its proprietors, physicians Mark Berman, a cosmetic surgeon, and Elliott Lander, a surgeon and urologist. The California enterprise has locations in Beverly Hills and Rancho Mirage with affiliates in 100 locations around the country.

Michael Hiltzik wrote in the Los Angeles Times,

"The lawsuits are the most aggressive steps yet taken by government regulators against rapidly proliferating stem-cell treatment clinics pitching scientifically unproven therapies to desperate patients, some with terminal illnesses. The lawsuits were filed at the request of the Food and Drug Administration, which last year announced that it would take a stern approach to what it described as the manufacture and use of unlicensed drugs."

Researcher Paul Knoepfler of UC Davis has been raising questions about unregulated and unproven stem cell treatments for a number of years. Writing yesterday on his blog, he called the federal action "historic." He said the suits could mark "a turning point for dealing with the for-profit stem cell clinic problem in the U.S."

Knoepfler also carried on his blog the full statements of the companies denying any wrong doing.

The California stem cell agency has also raised cautionary notes about unregulated treatments. 

Here are links to other stories on the lawsuits, which received national attention: Washington Post, The Associated Press and STAT. The Associated Press was carried by the New York Times and many other outlets online. The Times also carried this story by its own reporters.  Here is a recent column by Hiltzik on the California Stem Cell Treatment Center. The headline on the colum says "Patient lawsuits, federal investigations and a 'virtual' PhD: Inside a would-be stem cell empire." 

A California Scientist's Eight-Year Journey into the Byways of Dubious 'Stem Cell' Clinics

You could call it the "Knoepfler Effect."

It has bounced noticeably around the country in recent months, leading to headlines in the Washington Post, the Atlanta Constitution, the Los Angeles Times and other outlets in Florida, Seattle and elsewhere.

It involves the activities of dubious, so-called "stem cell clinics" -- enterprises once ignored by the mainstream media, the Food and Drug Administration as well as other regulators, including California lawmakers, and much of the established stem cell scientific community.

Not so today. Here is a sampling of the recent news coverage:

• "How ‘stem cell’ clinics became a Wild West for dodgy treatments"
• "Unregulated stem-cell clinics are proliferating across the United States"
• “There's a problem with stem cell therapy in Florida”
• "Patient lawsuits, federal investigations and a 'virtual' PhD: Inside a would-be stem cell empire"

Paul Knoepfler
UC Davis photo 

Over the last several months, these "stem cell" businesses have come under increasing scrutiny by media and regulators. Much of the credit for the attention must go to Paul Knoepfler, a stem cell researcher and blogger at UC Davis. About eight years ago, he began writing -- largely alone and in isolation -- on his blog about the problem. 

He was convinced that the persons lured into the "clinics" were paying large sums for so-called treatments that did not fulfill their promise and that, in fact, could be dangerous. In one case, Knoepfler went undercover -- sort of. He later tangled politely with the leading newspaper in California's state capital about how it was carrying full page ads from an unregulated clinic.

The watershed moment came in 2016 when Knoepfler and Leigh Turner of the University of Minnesota put a number to the matter -- 570 dubious "stem cell" firms nationwide with California leading the nation with 113. That was the key. Readers and regulators like solid numbers. They help focus attention, providing a hook for action and creating a new understanding.  Knoepfler and Turner's peer-reviewed scientific journal piece was the biggest stem cell story in the country that week.

Knoepfler also learned about the media game. He promptly returned media emails and calls and couched his responses in plain English -- "good quotes," as they are known in the trade.

Knoefler persisted even while some of his peers looked disparagingly at his blogging.  Back in 2012, one told Knoepfler that he was "skeptical of scientific social media with its 'twitting and the blobs(cq)'."

In California, however, his work helped to lead to a new law that forces the "stem cell" enterprises to inform their customers more fully about the nature of what might happen to their bodies.

It is a ticklish business to credit a specific individual with triggering a fresh wave of public attention to new and complex issues, such as stem cells and their dubious exploitation. Turner and others have been involved as well and deserve considerable credit. But Knoepfler was at the forefront and did, in fact, take a few arrows for his work.

The California Stem Cell Report asked Knoepfler for his brief thoughts about his stem cell adventures. He replied,

"Some highlights include times when patients decided not to get risky stem cells for themselves or their kids. I also have enjoyed getting to know so many cool people from diverse backgrounds all over the world I’ve only met because of the blog.

"Seeing things like the new California stem cell clinic law sprout up is exciting too, especially as now other states are trying to follow our state's lead it seems and maybe pass even better legislation. I’m also hopeful to have positive impact at the national level such as by somehow working a miracle to get the FDA to do more overall, but we’ll see how that turns out. 

"If that all sounds too cheery, then as my grandma might have said back in the 70s, 'It’s not all peaches and cream.' 

"There have been downsides too like various threats from clinics or their fans. I also feel like at times I’ve stepped in it with something I wrote or said when I could have avoided headaches if I had been wiser. Anyone can do that, but when you do it publicly such as on a blog then it’s got more bite to it. Doing all this stuff has risks to it. But overall it’s been worth it."  

A final note: People often shrug at the likelihood that they can make change in society. Many scientists as well shy from speaking out publicly, surrendering the public arena to snake oil peddlers. But the "Knoepfler Effect" stands as evidence that persistence and first-class work can, in fact, make a real difference in science and public policy. 

The Unregulated Stem Cell Wildfire: Fresh Look at Practices Not Approved by the FDA

They have crept across the country like a malignant rash, popping up from coast to coast. They take tens of thousands of dollars from desperate people from seeking a cure for afflictions ranging from cancer to blindness. Instead some become more ill.

You can see it yourself on your computer screen in the comfort of your own home. Just click on the map above. It was brought to you by Paul Knoepfler of UC Davis and Leigh Turner of the University of Minnesota. Back in 2016, they published the first ever look that documented the size of the unregulated stem cell clinic market. And California led the way with the most clinics.

Recently, they probed more deeply. Knoepfler wrote last week on his blog,

"In our new paper, Leigh and I also found that clinics marketing certain conditions and types of stem cells exhibited specific trends over the years. For instance amniotic stem cell clinics, while lagging behind bone marrow and fat stem cell clinics in numbers, show a sharp upward trend. This spike fits with increasing mainstream media advertising efforts by amniotic clinics.

The Regenerative Medicine article is ensconced behind a pay wall, but here is a snippet from its summary.

"Between 2009 and 2014, the number of new US stem cell businesses with websites grew rapidly, at least doubling on average every year. From 2014 to 2016, approximately 90–100 new stem cell business websites appeared per year. In contrast, from 2012 to the present, regulatory activity in the form of FDA warning letters has been limited. These data point to a problematic disconnect between a rapidly expanding US direct-to-consumer stem cell industry and limited FDA oversight of this marketplace. More consistent, timely and effective FDA actions are urgently needed."

Knoepfler said on his blog,

"While Leigh and I documented the nearly 600 clinics as of 2016, my sense is that there are likely to be upwards of 700 clinics today. What will the map of stem cell clinics look like in 2019 or 2020? What do you think? Fewer? More? Or about the same number of clinics? What would similar temporal maps of clinics in other countries look like?"

LA Times: Does California's New Stem Cell Law Do Enough to Regulate Exploitation of Desperate Patients?

The Los Angeles Times this morning carried a piece that praised the state's first-in-the-nation disclosure law concerning unregulated stem cell treatments, but the article also questioned whether the law is tough enough for the task.

Business columnist Michael Hiltzik wrote that the law, which goes into effect in January, is "a major step to address an emerging public health crisis."  But, he continued,

"(T)here’s reason to ask whether California’s law goes far enough to regulate businesses exploiting the desperation of patients with intractable diseases."

The law targets the more than 100 clinics in California that sell what Hiltzik described as  "unlicensed, unproven — and sometimes disproven — stem-cell 'treatments.'" For the first time, such California clinics will be required to disclose to their customers that the treatments are not approved or regulated by the federal government. The notices will advise the customers to consult with their physicians prior to treatment.

Hiltzik,  however, questioned the optimistic wording of the disclosure which says that the treatments have "not yet" been approved by the Food and Drug Administration (FDA). He said,

"This suggests that FDA endorsement may only be a matter of time — that the treatments may be premature, but not fictitious. That’s wildly optimistic and may itself foster a false hope for the treatments."

Hiltzik, a Pulitzer Prize winner,  said the state's Medical Board, which is charged with enforcement, has not been provided with funding to take on the clinics. Plus, he said the board, at best, is a "reluctant regulator."

State Sen. Ed Hernandez, D-Azusa, authored the law. He told Hiltzik the measure is a first step. Hiltzik quoted the legislator as saying,

 “Because it’s so new, we’re trying to figure out the best way to start the conversation.”

Hiltzik concluded,

"But lawmakers and regulators may need to move faster. What will make a difference in California may not be how the conversation starts, but where it leads."

California Moves to Protect Patients Seeking Unregulated Stem Cell Treatments

Beginning next year, California will have a new law that imposes the first-ever disclosure requirements on currently unregulated stem cell clinics that offer therapies that have not been approved by the Food and Drug Administration.

UC Davis stem cell scientist Paul Knoepfler, who for years has raised concerns about such clinics, wrote an item yesterday about the new law for his blog. It was headlined:

"Groundbreaking new California stem cell law gives consumer protections on clinics"

Ed Hernandez, Daily News photo

The measure is the first of its kind in California and probably the entire nation.  Authored by state Sen. Ed Hernandez, D-West Covina, it will require clinics to specifically notify its customers that he or she is about to undergo a treatment not approved by the FDA. The notification also must include advice encouraging customers to consult their primary care physician prior to undergoing a stem cell therapy.

A legislative analysis of the bill, SB512, cited a statement from the Center for Public Interest Law that said, 

"It is critical to patient safety that these individuals are not misled into believing they are partaking in an FDA-approved clinical trial and assuming serious health and financial risks in the process. The disclosure notices required by this bill are an important step in ensuring that patients have the information they need before making such monumental decisions about their treatment."

Paul Knoepfler, UC Davis photo

Knoepfler co-authored a research paper in 2015 that documented  the presence of nearly 600  unregulated clinics nationwide with California leading the way. He wrote on his blog, 

"Taken together, the provisions of this law will help consumers learn more about the stem cell clinic industry, make better decisions about their health and that of their loved ones, and delineate the difference between stem cell clinics versus compliant researchers conducting stem cell clinical trials with FDA approval.

"In the big picture, this new California law plus a more active FDA on the stem cell front together give me more hope that the wild west of stem cell clinics can be reined in sooner rather than later! Perhaps other states will follow suit with new laws and state medical boards will get more involved in overseeing stem cell therapies. With more 570 stem cell clinics in the US and more than 100 here in California alone, more efforts like these are needed on the consumer protection and educational outreach front."

Knoepfler deserves great credit for his efforts regarding unregulated clinics. It is fair to say that without his work, California would not have seen this law at this time. He was the first to document the size of the industry with the 2015 article, co-authored by Leigh Turner of the University of Minnesota.  Their work makes it abundantly clear that scientists can make a real difference on public policy issues if they are persistent and effective. One of Knoepfler's key tools was blogging, a practice that some scientists think is less than dignified. Nonetheless, his blogging helped to elevate the issue and served as a source for the news media as they looked into the matter. 

Like most new state laws, the law takes effect Jan. 1, 2018.

The Dual Images of Stem Cell Medicine Highlighted in the Headlines

Google news stem cell headlines this week

A couple of notable headlines surfaced this week dealing with stem cell matters, capturing something of the dichotomy in a field that has been heralded for its possible production of miracle cures. 

One story told of a person who plays football for a living, Doug Baldwin, who is known as the $46 million man.  He decided to spend some time in England this summer receiving what he believes was a stem cell treatment to prevent his knees from deteriorating. It was the type of story that gives many others hope that some sort of stem cell therapy could cure a serious or fatal condition despite the fact that no such cure has been approved for widespread use in this country. 

The other story told of a modest crackdown by the Food and Drug Administration (FDA) on a couple of unregulated stem cell clinics in this country, a move that many believe was long overdue. More than 500 such clinics exist in the United States.  One of the California clinics identified by the FDA was using a restricted small pox vaccine as part of its treatment. 

Your average health care consumer could justifiably wonder, "What in the world is going on? Is this stuff safe or what?" Some scientists have been long frustrated by the dueling public faces of stem cell medicine. On one hand, stories of miracle cures involving professional athletes generate great attention and tend to create faith in the efficacy of stem cell treatments, although the therapies involved do not measure up to scientific standards. On the other hand, the FDA is now taking a more active role in policing dubious actors in this business.

Our average medical consumer might believe that the FDA action signals a new assurance of stem cell safety or is it the other way around? Is the stem cell glass half full or half empty?

Paul Knoepfler, a stem cell researcher at UC Davis, has been the bellwether for seven years regarding news about unregulated and dubious stem cell clinics. He once even went sort of undercover to attend a public marketing session produced by one clinic in the Sacramento area. 

Knoepfler wrote this week on his blog about the FDA action, its implications and the questions that remain. He said the FDA action was a "very big deal." 

But Knoepfler said six important questions remain:

• "How much further will the FDA go with actual enforcement actions?
• "Will the FDA define fat stem cells as a drug (or not) in upcoming guidances?
• "How will the FDA handle non-homologous use of bone marrow cells in the commercial sector?
• "Will the FDA work to deal with the growing problem of unapproved, amniotic stem cell offerings? 
• "What about networks of stem cell businesses?
• "Will other entities like state medical boards use this FDA action as a spring-board to get off the sidelines and take positive action too?"

Meantime, patients will continue to have to wade through conflicting claims, hype and the possibility of serious medical harm or death as they ponder whether they should undergo a stem cell treatment. 

'A Reliable Voice of Reason:' A Look at a California Stem Cell Researcher/Blogger

Paul Knoepfler's TED talk has drawn more than one million views

The journal Science this week profiled UC Davis stem cell scientist and blogger Paul Knoepfler, describing him both as a consumer watchdog and a "dogged voice of caution."

In the article by Kelly Servick, George Daley,  dean of the Harvard Medical School, also called Knoepfler a "reliable voice of reason."  Daley noted that academics are "often more comfortable being provincial and insular, and not … mixing it up in the public debates."

Knoepfler began blogging seven years ago after -- at the age of 42 -- he was diagnosed with prostate cancer and given a roughly 50-50 chance of survival. He told Servick that he wanted to "expand how I had impact, beyond just the pure science." From the start, his blog went beyond science to patient advocacy.

Readers of the California Stem Cell Report are likely to be familiar with Knoepfler's blogging efforts, which are often reported here. We have followed his efforts since their inception. Over the years, his voice has grown to be heard in publications across the country. Just this week, he was widely quoted in coverage of the ground-breaking research into gene editing of human embryo.

(An aside from this writer, who is quoted in the Servick piece: One of the reasons that Knoepfler is quoted widely is that he returns media phone calls and can "speak English" -- meaning that he can explain science in terms that most persons can understand, at least those who read newspapers. That could have something to do with having an undergraduate degree in English.)

The Science article focused heavily on Knoepfler's writing about unregulated stem cell clinics, including research by him and Leigh Turner of the University of Minnesota that documented for the first time the size of that particular industry in this country. Their work counted 570 clinics with the most in California.

Why the focus on the unregulated treatments? Knoepfler told Science:

"'They were just saying, ‘Screw the rules, we're just going to set up shop and put up a website and start injecting people with stem cells....I saw that as a threat, first to patients, but to the field as well.'"  

California's Unregulated Stem Cell Clinics: Will State Regulators Step In to Cure Abuses?

The state of California has laws regarding substandard and questionable medical care, and now questions are being raised about whether it should step in to deal with the unregulated stem cell clinics that appear to flourishing in the Golden State.

The concerns come as the Los Angeles Times reported during the weekend about an enterprise in La Jolla, StemGenex Medical Group, which describes itself as "the premiere leader in the United States for regenerative medicine." 

The Times' Pulitzer Prize-winning columnist Michael Hiltzik wrote about the case of Jim Durgeloh, 59, a construction contractor from Washington state, who was looking for a solution to his hip problems, as well as other cases. Durgeloh paid StemGenex $15,000 for a treatment.

Hiltzik interviewed Durgelogh who was in Southern California with his wife following treatment. Hiltzik wrote,

"They were preparing to fly home, infused with the hope communicated by the clinic staff, who 'seemed very optimistic,' Durgeloh told me.

"A lawsuit in San Diego federal court suggests that StemGenex may have given the Durgelohs nothing but hope. Three StemGenex patients — two with diabetes and one with lupus — say they were misled by the medical group’s marketing pitch to pay $14,900 each in 2015 and 2016 for therapies that have had no effect.

"The lawsuit, which seeks class-action status, claims that StemGenex has made its money by 'targeting the ill and the elderly' with 'false, fabricated and purposefully misleading' claims about patient satisfaction."

Hiltzik continued,

"StemGenex, in its reply to the ... lawsuit, asserts that the plaintiffs 'cannot prove' that its 'representations regarding the efficacy of its stem cell treatments are actually false.' The plaintiffs, it continues, 'do not cite to a single scientific study that disproves [StemGenex’s] advertised claims.'"

UC Davis stem cell scientist Paul Knoepfler wrote yesterday on his blog about Hiltzik's article. Knoepfler was the co-author of a 2016 study that attracted nationwide attention with the disclosure that 570 unregulated stem cell clinics exist in the United States. California leads the way with 113.

Knoepfler focused on Hiltzik's disclosure that one of the StemGenex physicians, Scott Sessions, was placed on three years probation last February involving treatments not related to StemGenex. Sessions was accused of negligence "related to cosmetic surgery and other procedures he performed on two patients at an unrelated facility in 2011 and 2013."

Knoepfler continued,

"Sessions photo was up on the Stemgenex website...and then suddenly it wasn’t. Hiltzik also mentions that Stemgenex has had other questionable information on its web site in the past.

"With California having the most stem cell clinics selling non-FDA approved interventions of any state I hope the state medical board here will wake up to the fact that it needs to give this arena more attention."

The state has wide-ranging authority to regulate physicians. A document on the state Department of Consumer Affairs web site says that physicians can be disciplined for such things as  "not using accepted, effective treatments or diagnostic procedures," "not referring a patient to a specialist when
appropriate" and "continuing to use a procedure that is unnecessary."

A "Blind" Warning to Patients: Beware Unproven, Unregulated Stem Cell Treatments

“Disastrous” is how the New York Times this week described an ostensible stem cell treatment in Florida that left three older women blind or nearly blind. "Chilling reading" said the $3 billion California stem cell agency.

If you haven’t read about the matter yet, it is worth some attention. Denise Grady of the New York Times wrote,

“The cases expose gaps in the ability of government health agencies to protect consumers from unproven treatments offered by entrepreneurs who promote the supposed healing power of stem cells.”

Her article was based on a report in the New England Journal of Medicine that dug into the medicial and scientific details.

The matter involves loosely or non-regulated stem cell treatments in clinics that have shot up around the country, Paul Knoepfler, a stem cell research at UC Davis, and Leigh Turner, a bioethicist at the University of Minnesota, reported last year that at least 570 exist around in the country, with the most in California.

Kevin McCormack, director of communications at California's stem cell agency, wrote about the Florida matter on the agency's blog, He said,

"The report makes for chilling reading."

McCormack said it is a "warning to all patients about the dangers of getting unproven, unapproved stem cell therapies."

Knoepfler wrote on his blog,

“Is this just the tip of the iceberg for negative stem cell clinic outcomes given that there are around 600 such clinics in the US today largely operating generally without FDA approvals, lacking preclinical data to support what they are doing, and experimenting on thousands of patients for profit? 

“Where was the FDA in all of this and are they doing anything about it now?”

Knoepfler continued,

“The clinicaltrials.gov website remains a great, but also very problematic resource. Many patients seem to view anything listed on there as a legitimate, NIH-approved full-blown clinical trial and some clinics encourage that view, but that’s clearly not the case. I interviewed the leader of clinicaltrials.gov in 2014 and problems were already apparent to me back then from that discussion. Clinicaltrials.gov needs to provide patients with much more information (e.g. IND status, fee as inclusion criteria, etc.) and consider excluding certain listings.”While it is quite possible that it lacks the budget, the flexibility, and/or the authority to make such changes quickly, a lot is at stake. They need to make changes ASAP.”

Defying Basic Medical Know-how, Stem Cell Treatments and Fake News

A racing car driver, a celebrity TV surgeon and allegations of stem cell "fake news" surfaced this week on California stem cell blogs.

It was a matter of Dr. Oz, A.J. Foyt and a company called Cell Surgical Network Corp. of Rancho Mirage, Ca., which UC Davis stem cell scientist Paul Knoepfler says is the largest affiliated group of stem cell clinics in the United States.

But first Oz and Foyt. They were the subject of an item on the The Stem Cellar, the blog of California's $3 billion stem cell agency,

Kevin McCormack, communications director for the Oakland-based agency, wrote the piece, which was headlined "TV's Dr. Oz takes on clinics offering dubious stem cell treatments."

Foyt has said he has signed up for stem cell treatment in Mexico for issues stemming from his many injuries sustained in his very successful career in auto racing. Oz this week ran an investigative piece dealing with some of the 570 clinics in this country that offer unproven treatments.

The Oz show said that complications and death have resulted in some cases from treatments at these clinics here and abroad.

McCormack's concluding sentence:

 "Perhaps someone should tell A.J. Foyt."

Michael Hiltzik, a Pulitzer Prize winning columnist with the Los Angeles Times, also had an article concerning the Oz show, which reported that the treatments being offered at many of the 570 medical clinics defy "basic medical know-how."

Hiltzik also wrote that the Oz provided a "a withering assessment of doctors who claim to be engaged in clinical trials of stem cell treatments but 'ask you to give money upfront and mortgage your house and borrow from your friends’ credit cards — that’s not how medicine should be practiced.'"

Davis' Knoepfler dealt with the Cell Surgical Network and discussed its possible use of "laboratory-proliferated stem cells" in patients, which Knoepfler indicated would require federal approval.

The matter was addressed in an email Q-and-A with the leaders of the corporation, Mark Berman and Elliott Lander.

Berman and Landers' final point:

"All we care about is our patients. Providing them with the best and safest regenerative medical care in the world is what Americans deserve. We are not interested in anyone who desires to slow or obstruct this patient care by manipulating regulators into criminalizing certain medical practices. Therefore, we continue on our mission and ignore the fake news and rumors that generate blog ratings and spread fear and mistrust."

A Look at Stem Cell Treatments in Mexico with Ties to California

First part of KBPS' stem cell treatment series

A San Diego television station this week aired a solid series exploring the world of unproven stem cell treatments, including therapies in Mexico and involving a California company.

The work was produced on KBPS by David Wagner and ran as a two-part series(see image above). UC Davis researcher Paul Knoepfler, who earlier this year documented the existent of 570 unregulated stem cell clinics nationally, described Wagner's work as "an important new piece...on for-profit investigational stem cell treatments."

Companies mentioned by Wagner included Stemedica Cell Technologies, Inc., Global Stem Cell Health, Inc., both in the San Diego area, and Hospital Angeles in Tijuana, just south of San Diego in Mexico.

Stemedica is the firm connected to nationally reported treatments of the late hockey great Gordie Howe and former professional quarterbacks John Brodie and Bart Starr. (See here and here.)