The world of stem cell research is advancing rapidly, with new findings and discoveries seemingly every week. And yet some things that we knew years ago are still every bit as relevant today as they were then.
Take for example a TEDx talk by Dr. Daniel Kota, a stem cell researcher and the Director, Cellular Therapy – Research and Development at Houston Methodist.
Dr. Kota’s talk is entitled: “Promises and Dangers of Stem Cell Therapies”. In it he talks about the tremendous potential of stem cells to reverse the course of disease and help people battle previously untreatable conditions.
But he also warns about the gap between what the science can do, and what people believe it can do. He says too many people have unrealistic expectations of what is available right now, fueled by many unscrupulous snake oil salesmen who open clinics and offer “treatments” that are both unproven and unapproved by the Food and Drug Administration.
He says we need to “bridge the gap between stem cell science and society” so that people have a more realistic appreciation of what stem cells can do.
Sadly, as the number of clinics peddling these unproven therapies grows in the US, Dr. Kota’s message remains all too timely.
Every day I field phone calls and emails from people looking for a stem cell therapy to help them cope with everything from arthritis to cancer. Often, they will mention that they saw an ad for a clinic online or in a local newspaper claiming they had stem cell therapies that could help fix anything and asking me if they are legitimate.
Even after I try to explain that the therapies these clinics are offering haven’t been tested in a clinical trial and that there’s scant evidence to show they are even safe let alone effective, I know that a good chunk of the callers are going to try them anyway.
Now a survey by the Mayo Clinic takes a deeper dive into why people are willing to put science aside and open up their wallets to go to predatory stem cell clinics for so-called “therapies”.
Dr. Zubin Master. Photo courtesy Mayo Clinic
In a news release Dr. Zubin Master, a co-author of the study, says many patients are lured in by hype and hope.
“We learned that many patients interested in stem cells had beliefs that are not supported by current medical evidence. For example, many thought stem cells were better than surgery or the standard of care.”
The survey asked 533 people, who had approached the Mayo Clinic’s Regenerative Medicine Therapeutic Suites for a consultation about arthritis or musculoskeletal problems, three questions.
Why are you interested in stem cell treatment for your condition?
How did you find out about stem cell treatment for your condition?
Have you contacted a stem cell clinic?
A whopping 46 percent of those who responded said they thought stem cell therapy would help them avoid or at least delay having to get a hip or knee replacement, or that it was a better option than surgery. Another 26 percent said they thought it would ease the pain of an arthritic joint.
The fact that there is little or no evidence to support any of these beliefs didn’t seem to matter. Most people say they got their information about these “therapies” online or by talking to friends and family.
These “therapies” aren’t cheap either. They can cost thousands, sometimes tens of thousands of dollars, and that comes out of the patient’s pocket because none of this is covered by insurance. Yet every year people turn to these bogus clinics because they don’t like the alternatives, mainly surgery.
There is a lot of promising stem cell research taking place around the US trying to find real scientific solutions to arthritic joints and other problems. The California Institute for Regenerative Medicine (CIRM) has invested almost $24 million in this research. But until those approaches have proven themselves effective and, hopefully, been approved for wider use by the Food and Drug Administration, CIRM and other agencies will have to keep repeating a message many people just don’t want to hear, that these therapies are not yet ready for prime time.
What started out as an effort by Google to crack down on predatory stem cell clinics advertising bogus therapies seems to be getting diluted. Now the concern is whether that will make it easier for these clinics to lure unsuspecting patients to pay good money for bad treatments?
A little background might help here. For years Google placed no restrictions on ads by clinics that claimed their stem cell “therapies” could cure or treat all manner of ailments. Then in September of 2019 Google changed its policy and announced it was going to restrict advertisements for stem cell clinics offering unproven, cellular and gene therapies.
This new policy was welcomed by people like Dr. Paul Knoepfler, a stem cell scientist at UC Davis and longtime critic of these clinics. In his blog, The Niche, he said it was great news:
“Google Ads for stem cell clinics have definitely driven hundreds if not thousands of customers to unproven stem cell clinics. It’s very likely that many of the patients who have ended up in the hospital due to bad outcomes from clinic injections first went to those firms because of Google ads. These ads and certain particularly risky clinics also are a real threat to the legitimate stem cell and gene therapy fields.”
Now the search-engine giant seems to be adjusting that policy. Google says that starting July 11 it will permit ads for stem cell therapies approved by the US Food and Drug Administration (FDA). That’s fine. Anything that has gone through the FDA’s rigorous approval process deserves to be allowed to advertise.
The real concern lies with another adjustment to the policy where Google says it will allow companies to post ads as long as they are “exclusively educational or informational in nature, regardless of regulatory approval status.” The problem is, Google doesn’t define what constitutes “educational or informational”. That leaves the door open for these clinics to say pretty much anything they want and claim it meets the new guidelines.
To highlight that point Gizmodo did a quick search on Google using the phrase “stem cells for neuropathy” and quickly came up with a series of ads that are offering “therapies” clearly not approved by the FDA. One ad claimed it was “FDA registered”, a meaningless phrase but one clearly designed to add an air of authenticity to whatever remedy they were peddling.
The intent behind Google’s change of policy is clearly good, to allow companies offering FDA-approved therapies to advertise. However, the outcome may not be quite so worthy, and might once again put patients at risk of being tricked into trying “therapies” that will almost certainly not do them any good, and might even put them in harm’s way.
I have a confession. Deep down I’m shallow. So when something I am part of is acknowledged as one of the best, I delight in it (my fellow bloggers Katie and Esteban also delight in it, I am just more shameless about letting everyone know.)
And that is just what happened with this blog, The Stem Cellar. We have been named as one of the “22 best biology and stem cell blogs of 2022”. And not just by anyone. We were honored by Dr. Paul Knoepfler, a stem cell scientist, avid blogger and all-round renaissance man (full disclosure, Paul is a recipient of CIRM funding but that has nothing to do with this award. Obviously.)
We are particularly honored to be on the list because Paul includes some heavy hitters including The Signals Blog, a site that he describes this way:
“This one from our friends in Canada is fantastic. They literally have dozens of authors, which is probably the most of any stem cell-related website, and their articles include many interesting angles. They post really often too. I might rank Signal and The Stem Cellar as tied for best stem cell blog in 2021.”
Another one of the 22 is David Jensen’s California Stem Cell report which is dedicated to covering the work of, you guessed it, CIRM. So, not only are we great bloggers, we are apparently great to blog about.
As a further demonstration of my modesty I wanted to point out that Paul regularly produces ‘best of’ lists, including his recent “50 influencers on stem cells on Twitter to follow” which we were also on.
Photo of New York Attorney General Letitia James courtesy Wikimedia commons
A now-defunct New York City for-profit stem cell clinic — Park Avenue Stem Cell — was order by court to pay $5.1 million in potential consumer restitution, penalties, and costs for fraudulently and illegally advertising their stem cell procedures. The judgment resolves a 2019 lawsuit by New York State Attorney General Letitia James which claimed the defendants’ scammed patients out of thousands of dollars each for unproven and potentially harmful medical treatments involving stem cells.
According to the lawsuit, the clinic falsely advertised on their website, social media, television, and foreign language newspapers that they could treat a variety of serious medical conditions — including erectile dysfunction and Parkinson’s disease — using patients’ own stem cells. Consumers paid the clinic nearly $4,000 per procedure, with some consumers paying more than $20,000 for multiple procedures. Most of the procedures involved adipose stem cells, which are derived from a patient’s own fat tissues.
The court says the defendants misrepresented that their procedures were approved by the U.S. Food and Drug Administration (FDA), that their patients were participating in an established research study, and that their procedures had been endorsed by several scientific and medical organizations.
As a state agency, CIRM’s duty is to educate the public about the concerns over “stem cell tourism” and the growing number of predatory clinics that advertise unproven stem cell therapies at great cost to the patient.
In addition to hosting public forums on stem cell tourism concerns and resources for patients seeking stem cell treatments, CIRM partnered with California State Senator Ed Hernandez (D-West Covina) to create a new law that attempts to address the issue. The bill, SB 512, was passed in 2017 and now requires medical clinics whose stem cell treatments are not FDA approved to post notices and provide handouts to patients warning them about the potential risk.
Read more about this lawsuit at the New York Attorney general’s website.
When the COVID pandemic broke out researchers all over the world scrambled to find new approaches to tackling the virus. Some of these, such as the vaccines, proved remarkably effective. Others, such as the anti-parasite medication ivermectin or the anti-malaria drug chloroquine, were not only not helpful, they were sometimes harmful.
Part of the problem was the understandable desire to find something, anything that would protect people from the virus. But another part of the problem was that even with research that was based on solid science, the reporting of that research in the media sometimes tilted towards hype rather than hard evidence.
A new study in the journal Stem Cell Reports takes a look at the explosion of research targeting COVID. They highlighted the lack of rigor that sometimes accompanied that research, and the lack of regulation that allowed some predatory clinics to offer stem cell “therapies” that had never been tested in people let alone shown to be either safe or effective.
Dr. Leigh Turner, from the University of California Irvine and a co-author of the study, warned against studies that were cutting ethical and scientific corners. “Scientists, regulators, and policymakers must guard against the proliferation of poorly designed, underpowered, and duplicative studies that are launched with undue haste because of the pandemic, but are unlikely to provide convincing, clinically meaningful safety and efficacy data.”
The researchers cited an earlier study (by UC Davis’ Dr. Paul Knoepfler and Dr. Mina Kim) that looked at 70 clinical trials involving cell-based treatments for COVID-19. Drs. Knoepfler and Kim found that most were small, involving around 50 patients, and only 22.8% were randomized, double-blinded, and controlled experiments. They say even if these produced promising results they would have to be tested in much larger numbers to be of real benefit.
Another issue that Turner and his team highlighted was the hype that sometimes accompanied this work, citing news releases that over-hyped findings and failed to mention study limitations to gain more media coverage.
In a news releaseDr. Laertis Ikonomou, of the University at Buffalo and a co-author of the study, said over-hyping treatments is nothing new but that it seemed to become even more common during COVID.
“Therefore, it is even more important to communicate promising developments in COVID-19-related science and clinical management [responsibly]. Key features of good communication are an accurate understanding of new findings, including study limitations and avoidance of sensationalist language.”
“Realistic time frames for clinical translation are equally important as is the realization that promising interventions at preliminary stages may not always translate to proven treatments following rigorous testing.”
They also warned about clinics advertising “stem cell therapies” that were unproven and unlicensed and often involved injecting the patients’ own cells back into them. The researchers say it’s time that the FDA and other authorities cracked down on companies taking advantage of patients in this way.
“If companies and affiliated clinicians are not fined, forced to return to patients whatever profits they have made, confronted with criminal charges, subject to revocation of medical licensure, or otherwise subject to serious legal and financial consequences, it is possible that more businesses will be drawn to this space because of the profits that can be generated from selling unlicensed and unproven cell-based products in the midst of a pandemic.”
At a time when so many were dying or suffering long-term health problems as a result of COVID, it’s unconscionable that others were happy to cash in on the fear and pain to make a quick buck.
When the pandemic broke out the CIRM Board voted to approved $5 million in emergency funding to help develop new therapies to combat the virus. Altogether we funded 17 different projects including three clinical trials.
As of this moment, there are over two million podcasts and over 48 million episodes to listen to on your favorite listening device. If you’re a true crime enthusiast like me, you’ve surely heard of Casefile or one of the other 94 podcasts on the topic. But what if you’re looking for something a little less ghastly and a little more uplifting?
Dr. Daylon James, co-host of The Stem Cell Podcast
The Stem Cell Podcast is an informative and entertaining resource for scientists and science enthusiasts (or really, anyone) interested in learning about the latest developments in stem cell research.
Dr. Arun Sharma, co-host of The Stem Cell Podcast
On their latest episode, dynamic co-hosts and research scientists Dr. Daylon James and Dr. Arun Sharma sit down with our President & CEO, Dr. Maria Millan, to discuss the impact of California’s culture of innovation on CIRM, the challenge of balancing hope vs. hype in the context of stem cell research/therapies, and the evolution of the agency over the past 15 years.
Listen on as Dr. Millan highlights some of CIRM’s greatest victories and shares our mission for the future.
Stem cells have a number of amazing properties and tremendous potential to heal previously untreatable conditions. But they also have the potential to create a financial windfall for clinics that are more focused on lining their wallets than helping patients. Now the federal government is cracking down on some of these clinics in a couple of different ways.
The Food and Drug Administration (FDA) sent a warning letter to the Utah Cord Bank LLC and associated companies warning them that the products it sold – specifically “human umbilical cord blood, umbilical cord, and amniotic membrane derived cellular products” – were violating the law.
At the same time the Federal Trade Commission and the Georgia Office of the Attorney General began legal proceedings against Regenerative Medicine Institute of America. The lawsuit says the company claims its products can rebuild cartilage and help treat joint and arthritis pain, and is charging patients thousands of dollars for “treatments” that haven’t been shown to be either safe or effective.
CIRM has been a fierce opponents of bogus stem cell clinics for years and has worked with California lawmakers to try and crack down on them. We’re delighted to see that the federal government is stepping up its efforts to stop them marketing their snake oil to unsuspecting patients and will support them every step along the way.
CIRM has produced a short video and other easy to digest information on questions people should ask before signing up for any clinical trial. You can find those resources here.
CIRM has also published findings in Stem Cells Translational Medicine that discuss the three R’s–regulated, reliable, and reputable–and how these can help protect patients with uniform standards for stem cell treatments .
Anyone who knows anything about CIRM knows about Bob Klein. He’s the main author and driving force behind both Proposition 71 and Proposition 14, the voter-approved ballot initiatives that first created and then refunded CIRM. It’s safe to say that without Bob there’d be no CIRM.
Recently we had the great good fortune to sit down with Bob to chat about the challenges of getting a proposition on the ballot in a time of pandemic and electoral pandemonium, what he thinks CIRM’s biggest achievements are (so far) and what his future plans are.
You can’t fix a global problem at the local level. That’s the gist of a new perspective piece in the journal Stem Cell Reports that calls for a global approach to rogue stem cell clinics that offer bogus therapies.
The authors of the article are calling on the World Health Organization (WHO) to set up an advisory committee to draw up rules and regulations to help guide countries trying to shut these clinics down.
In a news release, senior author Mohamed Abou-el-Enein, the executive director of the joint University of Southern California/Children’s Hospital of Los Angeles Cell Therapy Program, says these clinics are trying to cash in on the promise of regenerative medicine.
“Starting in the early 2000s… unregulated stem cell clinics offering untested and poorly characterized treatments with insufficient information on their safety and efficacy began emerging all over the world, taking advantage of the media hype around stem cells and patients’ hope and desperation.”
Dr. Larry Goldstein
The authors include Lawrence Goldstein, PhD, a CIRM Board member and a Science Policy Fellows for the International Society for Stem Cell Research (ISSCR).
Zubin Master, an associate professor of biomedical ethics at the Mayo Clinic, says the clinics prey on vulnerable people who have serious medical conditions and who have often tried conventional medical approaches without success.
“We should aim to develop pathways to provide patients with evidenced-based experimental regenerative intervention as possible options where there is oversight, especially in circumstances where there is no suitable alternative left.”
The report says: “The unproven SCI (stem cell intervention) industry threatens the advancement of regenerative medicine. Reports of adverse events from unproven SCIs has the potential to affect funding and clinical trial recruitment, as well as increasing burdens among regulatory agencies to oversee the industry.
Permitting unregulated SCIs to flourish demonstrates a lack of concern over patient welfare and undermines the need for scientific evidence for medicinal product R&D. While some regulatory agencies have limited oversight or enforcement powers, or choose not to use them, unproven SCI clinics still serve to undermine authority given to regulatory agencies and may reduce public trust impacting the development of safe and effective therapies. Addressing the continued proliferation of clinics offering unproven SCIs is a problem worth addressing now.”
The authors say the WHO is uniquely positioned to help create a framework for the field that can help address these issues. They recommend setting up an advisory committee to develop global standards for regulations governing these clinics that could be applied in all countries. They also say we need more educational materials to let physicians as well as patients understand the health risks posed by bogus clinics.
This article comes out in the same week that reports by the Pew Charitable Trust and the FDA also called for greater regulation of these predatory clinics (we blogged about that here). Clearly there is growing recognition both in the US and worldwide that these clinics pose a threat not just to the health and safety of patients, but also to the reputation of the field of regenerative medicine as a whole.
“I believe that the global spread of unproven stem cell therapies reflects critical gaps in the international system for responding to health crises, which could put the life of thousands of patients in danger,” Abou-el-Enein says. “Urgent measures are needed to enhance the global regulatory capacity to detect and respond to this eminent crisis rapidly.”
The Stem Cellar 