When Google turns on you, you know you are in trouble

For years CIRM and others in the stem cell community (hello Paul Knoepfler) have been warning people about the dangers of going to clinics offering unproven and unapproved stem cell therapies. Recently the drum beat of people and organizations coming out in support of that stand has grown louder and louder. Mainstream media – TV and print – have run articles about these predatory clinics. And now, Google has joined those ranks, announcing it will restrict ads promoting these clinics.

“We regularly review and revise our advertising policies. Today, we’re announcing a new Healthcare and medicines policy to prohibit advertising for unproven or experimental medical techniques such as most stem cell therapy, cellular (non-stem) therapy, and gene therapy.”

Deepak Srivastava: Photo courtesy Gladstone Institutes

The president of the International Society for Stem Cell Research (ISSCR) Dr. Deepak Srivastava quickly issued a statement of support, saying:

“Google’s new policy banning advertising for speculative medicines is a much-needed and welcome step to curb the marketing of unscrupulous medical products such as unproven stem cell therapies. While stem cells have great potential to help us understand and treat a wide range of diseases, most stem cell interventions remain experimental and should only be offered to patients through well-regulated clinical trials. The premature marketing and commercialization of unproven stem cell products threatens public health, their confidence in biomedical research, and undermines the development of legitimate new therapies.”

Speaking of Deepak – we can use first names here because we are not only great admirers of him as a physician but also as a researcher, which is why we have funded some of his research – he has just published a wonderfully well written article criticizing these predatory clinics.

The article – in Scientific American – is titled “Don’t Believe Everything You Hear About Stem Cells” and rather than paraphrase his prose, I think it best if you read it yourself. So, here it is.

Enjoy.

Don’t Believe Everything You Hear about Stem Cells

The science is progressing rapidly,but bad actors have co-opted stem cells’ hope and promise by preying on unsuspecting patients and their families

Stem cell science is moving forward rapidly, with potential therapies to treat intractable human diseases on the horizon.Clinical trials are now underway to test the safety and effectiveness of stem cell–based treatments for blindness,spinal cord injury,heart disease,Parkinson’s disease, and more,some with early positive results.A sense of urgency drives the scientific community, and there is tremendous hope to finally cure diseases that, to date, have had no treatment.


But don’t believe everything you hear about stem cells. Advertisements and pseudo news articles promote stem cell treatments for everything from Alzheimer’s disease,autism and ALS, to cerebral palsy and other diseases.The claims simply aren’t true–they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public.Patients and their families can be misled by deceptive marketing from unqualified physicians who often don’t have appropriate medical credentials and offer no scientific evidence of their claims.In many cases, the cells being utilized are not even true stem cells.

Advertisements for stem cell treatments are showing up everywhere, with too-good-to-be-true claims and often a testimonial or two meant to suggest legitimacy or efficacy.Beware of the following:

    •       Claims that stem cell treatments can treat a wide range of diseases using a singular stem cell type. This is unlikely to be true.

    •       Claims that stem cells taken from one area of the body can be used to treat another, unrelated area of the body. This is also unlikely to be true.     •       Patient testimonials used to validate a particular treatment, with no scientific evidence. This is a red flag.

    •       Claims that evidence doesn’t yet exist because the clinic is running a patient-funded trial. This is a red flag; clinical trials rarely require payment for experimental treatment.

    •       Claims that the trial is listed on ClinicalTrials.gov and is therefore NIH-approved. This may not be true. The Web site is simply a listing; not all are legitimate trials.

    •       The bottom line: Does the treatment sound too good to be true? If so, it probably is. Look for concrete evidence that the treatment works and is safe.

Hundreds of clinics offer costly, unapproved and unproven stem cell interventions, and patients may suffer physical and financial harm as a result.A Multi-Pronged Approach to Deal with Bad Actors 

The International Society for Stem Cell Research (ISSCR)has long been concerned that bad actors have co-opted the hope and promise of stem cell science to prey on unsuspecting patients and their families.

We read with sadness and disappointment the many stories of people trying unproven therapies and being harmed, including going blind from injections into the eyes or suffering from a spinal tumor after an injection of stem cells.Patients left financially strapped, with no physical improvement in their condition and no way to reclaim their losses, are an underreported and underappreciated aspect of these treatments.

Since late 2017, the Food and Drug Administration has stepped up its regulatory enforcement of stem cell therapies and provided a framework for regenerative medicine products that provides guidelines for work in this space.The agency has alerted many clinics and centers that they are not in compliance and has pledged to bring additional enforcement action if needed.

A Multi-Pronged Approach to Deal with Bad Actors  The International Society for Stem Cell Research (ISSCR) has long been concerned that bad actors have co-opted the hope and promise of stem cell science to prey on unsuspecting patients and their families.

We read with sadness and disappointment the many stories of people trying unproven therapies and being harmed, including going blind from injections into the eyesor suffering from a spinal tumor after an injection of stem cells.Patients left financially strapped, with no physical improvement in their condition and no way to reclaim their losses, are an underreported and underappreciated aspect of these treatments.

Since late 2017, the Food and Drug Administration has stepped up its regulatory enforcement of stem cell therapies and provided a framework for regenerative medicine products that provides guidelines for work in this space.The agency has alerted many clinics and centers that they are not in compliance and has pledged to bring additional enforcement action if needed.

In recent weeks, a federal judge granted the FDA a permanent injunction against U.S. Stem Cell, Inc. and U.S. Stem Cell Clinic, LLC for adulterating and misbranding its cellular products and operating outside of regulatory authority.We hope this will send a strong message to other clinics misleading patients with unapproved and potentially harmful cell-based products.

The Federal Trade Commission has also helped by identifying and curtailing unsubstantiated medical claims in advertising by several clinics. Late in 2018 the FTC won a $3.3-million judgment against two California-based clinics for deceptive health claims. The Federal Trade Commission has also helped by identifying and curtailing unsubstantiated medical claims in advertising by several clinics. Late in 2018 the FTC won a $3.3-million judgment against two California-based clinics for deceptive health claims.

These and other actions are needed to stem the tide of clinics offering unproved therapies and the people who manage and operate them.

Improving Public Awareness

We’re hopeful that the FDA will help improve public awareness of these issues and curb the abuses on ClinicalTrials.gov,a government-run Web site being misused by rogue clinics looking to legitimize their treatments. They list pay-to-participate clinical trials on the site, often without developing, registering or administering a real clinical trial.

The ISSCR Web site A Closer Look at Stem Cellsincludes patient-focused information about stem cells,with information written and vetted by stem cell scientists.The site includes how and where to report adverse events and false marketing claims by stem cell clinics.I encourage you to visit and learn about what is known and unknown about stem cells and their potential for biomedicine.The views expressed are those of the author(s) and are not necessarily those of Scientific American.

Media matters in spreading the word

Cover of New Yorker article on “The Birth Tissue Profiteers”. Illustration by Ben Jones

When you have a great story to tell the best and most effective way to get it out to the widest audience is still the media, both traditional mainstream and new social media. Recently we have seen three great examples of how that can be done and, hopefully, the benefits that can come from it.

First, let’s go old school. Earlier this month Caroline Chen wrote a wonderful in-depth article about clinics that are cashing in on a gray area in stem cell research. The piece, a collaboration between the New Yorker magazine and ProPublica, focused on the use of amniotic stem cell treatments and the gap between what the clinics who offer it are claiming it can do, and the reality.

Here’s one paragraph profiling a Dr. David Greene, who runs a company providing amniotic fluid to clinics. It’s a fine piece of writing showing how the people behind these therapies blur the lines between fact and reality, not just about the cells but also about themselves:

“Greene said that amniotic stem cells derive their healing power from an ability to develop into any kind of tissue, but he failed to mention that mainstream science does not support his claims. He also did not disclose that he lost his license to practice medicine in 2009, after surgeries he botched resulted in several deaths. Instead, he offered glowing statistics: amniotic stem cells could help the heart beat better, “on average by twenty per cent,” he said. “Over eighty-five per cent of patients benefit exceptionally from the treatment.”

Greene later backpedals on that claim, saying:

“I don’t claim that this is a treatment. I don’t claim that it cures anything. I don’t claim that it’s a permanent fix. All I discuss is maybe, potentially, people can get some improvements from stem-cell care.”

CBS2 TV Chicago

This week CBS2 TV in Chicago did their own investigative story about how the number of local clinics offering unproven and unapproved therapies is on the rise. Reporter Pam Zekman showed how misleading newspaper ads brought in people desperate for something, anything, to ease their arthritis pain.

She interviewed two patients who went to one of those clinics, and ended up out of pocket, and out of luck.

“They said they would regenerate the cartilage,” Patricia Korona recalled. She paid $4500 for injections in her knee, but the pain continued. Later X-rays were ordered by her orthopedic surgeon.

He found bone on bone,” Korona said. “No cartilage grew, which tells me it failed; didn’t work.”

John Zapfel paid $14,000 for stem cell injections on each side of his neck and his shoulder. But an MRI taken by his current doctor showed no improvement.

“They ripped me off, and I was mad.” Zapfel said.      

TV and print reports like this are a great way to highlight the bogus claims made by many of these clinics, and to shine a light on how they use hype to sell hope to people who are in pain and looking for help.

At a time when journalism seems to be increasingly under attack with accusations of “fake news” it’s encouraging to see reporters like these taking the time and news outlets devoting the resources to uncover shady practices and protect vulnerable patients.

But the news isn’t all bad, and the use of social media can help highlight the good news.

That’s what happened yesterday in our latest CIRM Facebook Live “Ask the Stem Cell Team” event. The event focused on the future of stem cell research but also included a really thoughtful look at the progress that’s been made over the last 10-15 years.

We had two great guests, UC Davis stem cell researcher and one of the leading bloggers on the field, Paul Knoepfler PhD; and David Higgins, PhD, a scientist, member of the CIRM Board and a Patient Advocate for Huntington’s Disease. They were able to highlight the challenges of the early years of stem cell research, both globally and here at CIRM, and show how the field has evolved at a remarkable rate in recent years.

Paul Knoepfler

Naturally the subject of the “bogus clinics” came up – Paul has become a national expert on these clinics and is quoted in the New Yorker article – as did the subject of the frustration some people feel at what they consider to be the too-slow pace of progress. As David Higgins noted, we all think it’s too slow, but we are not going to race recklessly ahead in search of something that might heal if we might also end up doing something that might kill.

David Higgins

A portion of the discussion focused on funding and, in particular, what happens if CIRM is no longer around to fund the most promising research in California. We are due to run out of funding for new projects by the end of this year, and without a re-infusion of funds we will be pretty much closing our doors by the end of 2020. Both Paul and David felt that could be disastrous for the field here in California, depriving the most promising projects of support at a time when they needed it most.

It’s probably not too surprising that three people so closely connected to CIRM (Paul has received funding from us in the past) would conclude that CIRM is needed for stem cell research to not just survive but thrive in California.

A word of caution before you watch: fashion conscious people may be appalled at how my pocket handkerchief took on a life of its own.

CIRM public events highlight uncertain future of stem cell research

When governments cut funding for scientific research the consequences can be swift, and painful. In Canada last week for example, the government of Ontario cut $5 million in annual funding for stem cell research, effectively ending a project developing a therapy to heal the damaged lungs of premature babies.

Here in the US the federal government is already placing restrictions on support for fetal tissue research and there is speculation embryonic stem cell research could be next. That’s why agencies like CIRM are so important. We don’t rely on a government giving us money every year. Instead, thanks to the voters of California, we have had a steady supply of funds to enable us to plan long-term and support multi-year projects.

But those funds are due to run out soon. We anticipate funding our last new awards this year and while we have enough money to continue supporting all the projects our Board has already approved, we won’t be able to take on any new projects. That’s bad news for the scientists and, ultimately, really bad for the patients who are in need of new treatments for currently incurable diseases.

We are going to talk about that in two upcoming events.

UC San Diego Sanford Stem Cell Clinical Center

The first is a patient advocate event at UC San Diego on Tuesday, May 28th from 12.30pm to 1.30pm. It’s free, there is parking and snacks and refreshments will be available.

This will feature UC San Diego’s Dr. Catriona Jamieson, CIRM’s President and CEO Dr. Maria Millan and CIRM Board member and Patient Advocate for Parkinson’s Disease, David Higgins PhD. The three will talk about the exciting progress being made at UC San Diego and other programs around California, but also the uncertain future and the impact that could have for the field as a whole.

Here’s a link to an Eventbrite page that has more information about the event and also a link to allow you to RSVP ahead of time.

For all of you who don’t live in the San Diego Area – or who do but can’t make it to the event – we are holding a similar discussion online on a special Facebook Live: Ask the Stem Cell Team About the Future of Stem Cell Research event on Thursday, May 30th from noon till 1pm PDT.

This also features Dr. Millan and Dr. Higgins, but it also features UC Davis stem cell scientist, CIRM-grantee and renowned blogger Paul Knoepfler PhD.

Each brings their own experience, expertise and perspective on the field and will discuss the impact that a reduction in funding for stem cell research would have, not just in the short term but in the long run.

Because we all have a stake in what happens, both events – whether it’s in person or online – include time for questions from you, the audience.

You can find our Facebook Live: Ask the Stem Cell Team About the Future of Stem Cell Research on our Facebook page at noon on May 30th PDT

Media shine a spotlight on dodgy stem cell clinics

A doctor collects fat from a patient’’s back as part of an experimental stem cell procedure in Beverly Hills, Calif. on Dec. 5, 2014. (Raquel Maria Dillon / Associated Press)

For several years now, we have been trying to raise awareness about the risks posed by clinics offering unproven or unapproved stem cell therapies. At times it felt as if we were yelling into the wind, that few people were listening. But that’s slowly changing. A growing number of TV stations and newspapers are picking up the message and warning their readers and viewers. It’s a warning that is getting national exposure.

Why are we concerned about these clinics? Well, they claim their therapies, which usually involve the patient’s own fat or blood cells, can cure everything from arthritis to Alzheimer’s. However, they offer no scientific proof, have no studies to back up their claims and charge patients thousands, sometimes tens of thousands of dollars.

In the LA Times, for example, reporter Usha Lee McFarling, wrote an article headline “California has gone crazy for sketchy stem cell treatments”. In it she writes about the claims made by these clinics and the dangers they pose:

“If it sounds too good to be true, it is. There is no good scientific evidence the pricey treatments work, and there is growing evidence that some are dangerous, causing blindness, tumors and paralysis. Medical associations, the federal government and even Consumer Reports have all issued stern warnings to patients about the clinics.”

In Denver, the ABC TV station recently did an in-depth interview with a local doctor who is trying to get Colorado state legislators to take legal action against stem cell clinics making these kinds of unsupported claims.

Chris Centeno of the Centeno-Schultz Clinic, who’s specialized in regenerative medicine and research for more than a decade, said too many people are simply being scammed.

“It’s really out of control,” he told the station.

ABC7 did a series of reports last year on the problem and that may be prompting this push for a law warning consumers about the dangers posed by these unregulated treatments which are advertised heavily online, on TV and in print.

In California there is already one law on the books attempting to warn consumers about these clinics. CIRM worked with State Senator Ed Hernandez to get that passed (you can read about that here) and we are continuing to support even stronger measures.

And the NBC TV station in San Diego recently reported on the rise of stem cell clinics around the US, a story that was picked up by the networks and run on the NBC Today Show.

One of the critical elements in helping raise awareness about the issue has been the work done by Paul Knoepfler and Leigh Turner in identifying how many of these clinics there are around the US. Their report, published in the journal Cell Stem Cell, was the first to show how big the problem is. It attracted national attention and triggered many of the reports that followed.

It is clear momentum is building and we hope to build on that even further. Obviously, the best solution would be to have the Food and Drug Administration (FDA) crack down on these clinics, and in some cases they have. But the FDA lacks the manpower to tackle all of them.

That’s where the role of the media is so important. By doing stories like these and raising awareness about the risks these clinics pose they can hopefully help many patients avoid treatments that will do little except make a dent in their pocket.

It’s time to vote for the Stem Cell Person of the Year

KnoepflerPaul14263

Paul Knoepfler

Oh well, it’s going to be another year of disappointment for me. Not only did I fail to get any Nobel Prize (I figured my blogs might give me a shot at Literature after they gave it to Bob Dylan last year), but I didn’t get a MacArthur Genius Award. Now I find out I haven’t even made the short list for the Stem Cell Person of the Year.

The Stem Cell Person of the Year award is given by UC Davis researcher, avid blogger and CIRM Grantee Paul Knoepfler. (You can vote for the Stem Cell Person of the Year here). In his blog, The Niche, Paul lists the qualities he looks for:

“The Stem Cell Person of the Year Award is an honor I give out to the person in any given year who in my view has had the most positive impact in outside-the-box ways in the stem cell and regenerative medicine field. I’m looking for creative risk-takers.”

“It’s not about who you know, but what you do to help science, medicine, and other people.”

Paul invites people to nominate worthy individuals – this year there are 20 nominees – people vote on which one of the nominees they think should win, and then Paul makes the final decision. Well, it is his blog and he is putting up the $2,000 prize money himself.

This year’s nominees are nothing if not diverse, including

  • Anthony Atala, a pioneering researcher at Wake Forest Institute for Regenerative Medicine in North Carolina
  • Bao-Ngoc Nguyen, who helped create California’s groundbreaking new law targeting clinics which offer unproven stem cell therapies
  • Judy Roberson, a tireless patient advocate, and supporter of stem cell research for Huntington’s disease

Whoever wins will be following in some big footsteps including patient advocates Ted Harada and Roman Reed, as well as scientists like Jeanne Loring, Masayo Takahashi,  and Elena Cattaneo.

So vote early, vote often.

LINK: Vote for the 2017 Stem Cell Person of the Year

Stem Cell Stories that Caught Our Eye: New law to protect consumers; using skin to monitor blood sugar; and a win for the good guys

Hernendez

State Senator Ed Hernandez

New law targets stem cell clinics that offer therapies not approved by the FDA

For some time now CIRM and others around California have been warning consumers about the risks involved in going to clinics that offer stem cell therapies that have not been tested in a clinical trial or approved by the U.S. Food and Drug Administration (FDA) for use in patients.

Now a new California law, authored by State Senator Ed Hernandez (D-West Covina) attempts to address that issue. It will require medical clinics whose stem cell treatments are not FDA approved, to post notices and provide handouts to patients warning them about the potential risk.

In a news release Sen. Hernandez said he hopes the new law, SB 512, will protect consumers from early-stage, unproven experimental therapies:

“There are currently over 100 medical offices in California providing non-FDA approved stem cell treatments. Patients spend thousands of dollars on these treatments, but are totally unaware of potential risks and dangerous side effects.”

Sen. Hernandez’s staffer Bao-Ngoc Nguyen crafted the bill, with help from CIRM Board Vice Chair Sen. Art Torres, Geoff Lomax and UC Davis researcher Paul Knoepfler, to ensure it targeted only clinics offering non-FDA approved therapies and not those offering FDA-sanctioned clinical trials.

For example the bill would not affect CIRM’s Alpha Stem Cell Clinic Network because all the therapies offered there have been given the green light by the FDA to work with patients.

Blood_Glucose_Testing 

Using your own skin as a blood glucose monitor

One of the many things that people with diabetes hate is the constant need to monitor their blood sugar level. Usually that involves a finger prick to get a drop of blood. It’s simple but not much fun. Attempts to develop non-invasive monitors have been tried but with limited success.

Now researchers at the University of Chicago have come up with another alternative, using the person’s own skin to measure their blood glucose level.

Xiaoyang Wu and his team accomplished this feat in mice by first creating new skin from stem cells. Then, using the gene-editing tool CRISPR, they added in a protein that sticks to sugar molecules and another protein that acts as a fluorescent marker. The hope was that the when the protein sticks to sugar in the blood it would change shape and emit fluorescence which could indicate if blood glucose levels were too high, too low, or just right.

The team then grafted the skin cells back onto the mouse. When those mice were left hungry for a while then given a big dose of sugar, the skin “sensors” reacted within 30 seconds.

The researchers say they are now exploring ways that their findings, published on the website bioRxiv, could be duplicated in people.

While they are doing that, we are supporting ViaCytes attempt to develop a device that doesn’t just monitor blood sugar levels but also delivers insulin when needed. You can read about our recent award to ViaCyte here.

Deepak

Dr. Deepak Srivastava

Stem Cell Champion, CIRM grantee, and all-round-nice guy named President of Gladstone Institutes

I don’t think it would shock anyone to know that there are a few prima donnas in the world of stem cell research. Happily, Dr. Deepak Srivastava is not one of them, which makes it such a delight to hear that he has been appointed as the next President of the Gladstone Institutes in San Francisco.

Deepak is a gifted scientist – which is why we have funded his work – a terrific communicator and a really lovely fella; straight forward and down to earth.

In a news release announcing his appointment – his term starts January 1 next year – Deepak said he is honored to succeed the current President, Sandy Williams:

“I joined Gladstone in 2005 because of its unique ability to leverage diverse basic science approaches through teams of scientists focused on achieving scientific breakthroughs for mankind’s most devastating diseases. I look forward to continue shaping this innovative approach to overcome human disease.”

We wish him great success in his new role.

 

 

 

CIRM weekly stem cell roundup: stomach bacteria & cancer; vitamin C may block leukemia; stem cells bring down a 6’2″ 246lb football player

gastric

This is what your stomach glands looks like from the inside:  Credit: MPI for Infection Biology”

Stomach bacteria crank up stem cell renewal, may be link to gastric cancer (Todd Dubnicoff)

The Centers for Disease Control and Prevention estimate that two-thirds of the world’s population is infected with H. pylori, a type of bacteria that thrives in the harsh acidic conditions of the stomach. Data accumulated over the past few decades shows strong evidence that H. pylori infection increases the risk of stomach cancers. The underlying mechanisms of this link have remained unclear. But research published this week in Nature suggests that the bacteria cause stem cells located in the stomach lining to divide more frequently leading to an increased potential for cancerous growth.

Tumors need to make an initial foothold in a tissue in order to grow and spread. But the cells of our stomach lining are replaced every four days. So, how would H. pylori bacterial infection have time to induce a cancer? The research team – a collaboration between scientists at the Max Planck Institute in Berlin and Stanford University – asked that question and found that the bacteria are also able to penetrate down into the stomach glands and infect stem cells whose job it is to continually replenish the stomach lining.

Further analysis in mice revealed that two groups of stem cells exist in the stomach glands – one slowly dividing and one rapidly dividing population. Both stem cell populations respond similarly to an important signaling protein, called Wnt, that sustains stem cell renewal. But the team also discovered a second key stem cell signaling protein called R-spondin that is released by connective tissue underneath the stomach glands. H. pylori infection of these cells causes an increase in R-spondin which shuts down the slowly dividing stem cell population but cranks up the cell division of the rapidly dividing stem cells. First author, Dr. Michal Sigal, summed up in a press release how these results may point to stem cells as the link between bacterial infection and increased risk of stomach cancer:

“Since H. pylori causes life-long infections, the constant increase in stem cell divisions may be enough to explain the increased risk of carcinogenesis observed.”

vitamin-c-1200x630

Vitamin C may have anti-blood cancer properties

Vitamin C is known to have a number of health benefits, from preventing scurvy to limiting the buildup of fatty plaque in your arteries. Now a new study says we might soon be able to add another benefit: it may be able to block the progression of leukemia and other blood cancers.

Researchers at the NYU School of Medicine focused their work on an enzyme called TET2. This is found in hematopoietic stem cells (HSCs), the kind of stem cell typically found in bone marrow. The absence of TET2 is known to keep these HSCs in a pre-leukemic state; in effect priming the body to develop leukemia. The researchers showed that high doses of vitamin C can prevent, or even reverse that, by increasing the activity level of TET2.

In the study, in the journal Cell, they showed how they developed mice that could have their levels of TET2 increased or decreased. They then transplanted bone marrow with low levels of TET2 from those mice into healthy, normal mice. The healthy mice started to develop leukemia-like symptoms. However, when the researchers used high doses of vitamin C to restore the activity levels of TET2, they were able to halt the progression of the leukemia.

Now this doesn’t mean you should run out and get as much vitamin C as you can to help protect you against leukemia. In an article in The Scientist, Benjamin Neel, senior author of the study, says while vitamin C does have health benefits,  consuming large doses won’t do you much good:

“They’re unlikely to be a general anti-cancer therapy, and they really should be understood based on the molecular understanding of the many actions vitamin C has in cells.”

However, Neel says these findings do give scientists a new tool to help them target cells before they become leukemic.

Jordan reed

Bad toe forces Jordan Reed to take a knee: Photo courtesy FanRag Sports

Toeing the line: how unapproved stem cell treatment made matters worse for an NFL player  

American football players are tough. They have to be to withstand pounding tackles by 300lb men wearing pads and a helmet. But it wasn’t a crunching hit that took Washington Redskins player Jordan Reed out of the game; all it took to put the 6’2” 246 lb player on the PUP (Physically Unable to Perform) list was a little stem cell injection.

Reed has had a lingering injury problem with the big toe on his left foot. So, during the off-season, he thought he would take care of the issue, and got a stem cell injection in the toe. It didn’t quite work the way he hoped.

In an interview with the Richmond Times Dispatch he said:

“That kind of flared it up a bit on me. Now I’m just letting it calm down before I get out there. I’ve just gotta take my time, let it heal and strengthen up, then get back out there.”

It’s not clear what kind of stem cells Reed got, if they were his own or from a donor. What is clear is that he is just the latest in a long line of athletes who have turned to stem cells to help repair or speed up recovery from an injury. These are treatments that have not been approved by the Food and Drug Administration (FDA) and that have not been tested in a clinical trial to make sure they are both safe and effective.

In Reed’s case the problem seems to be a relatively minor one; his toe is expected to heal and he should be back in action before too long.

Stem cell researcher and avid blogger Dr. Paul Knoepfler wrote he is lucky, others who take a similar approach may not be:

“Fortunately, it sounds like Reed will be fine, but some people have much worse reactions to unproven stem cells than a sore toe, including blindness and tumors. Be careful out there!”

Texas tries to go it alone in offering unproven stem cell therapies to patients

Texas Capitol. (Shutterstock)

One of the most hotly debated topics in stem cell research is whether patients should be able to have easier access to unproven therapies using their own stem cells, at their own risk, and their own cost. It’s a debate that is dividing patients and physicians, researchers and lawmakers.

In California, a bill working its way through the state legislature wants to have warning signs posted in clinics offering unproven stem cell therapies, letting patients know they are potentially putting themselves at risk.

Texas is taking a very different approach. A series of bills under consideration would make it easier for clinics to offer unproven treatments; make it easier for patients with chronic illnesses to use the “right to try” law to take part in early-stage clinical trials (in the past, it was only patients with a terminal illness who could do that); and allow these clinics to charge patients for these unproven stem cell therapies.

Not surprisingly, the Texas bills are attracting some widely divergent views. Many stem cell researchers and some patient advocates are opposed to them, saying they prey on the needs of vulnerable people, offering them treatments – often costing thousands, even tens of thousands of dollars – that have little or no chance of success.

In an article on STATnews, Sean Morrison, a stem cell researcher at the University of Texas Southwestern Medical Center, in Dallas, said the Texas bills would be bad for patients:

“When patients get desperate, they have a capacity to suspend disbelief. When offered the opportunity of a therapy they believe in, even without data and if the chances of benefit are low, they’ll fight for access to that therapy. The problem is there are fraudulent stem cell clinics that have sprung up to exploit that.”

Patients like Jennifer Ziegler disagree with that completely. Ziegler has multiple sclerosis and has undergone three separate stem cell treatments – two in the US and one in Panama – to help treat her condition. She is also a founding member of Patients For Stem Cells (PFSC):

Jennifer Ziegler

“PFSC does not believe our cells are drugs. We consider the lack of access to adult stem cells an overreach by the federal government into our medical freedoms. My cells are not mass produced, and they do not cross state lines. An adult stem cell treatment is a medical procedure, between me, a fully educated patient, and my fully competent doctor.”

The issue is further complicated because the US Food and Drug Administration (FDA) – which has regulatory authority over stem cell treatments – considers the kinds of therapies these clinics offer to be a technical violation of the law. So even if Texas passes these three bills, they could still be in violation of federal law. However, a recent study in Cell Stem Cell showed that there are some 570 clinics around the US offering these unproven therapies, and to date the FDA has shown little inclination to enforce the law and shut those clinics down.

UC Davis stem cell researcher – and CIRM grantee – Paul Knoepfler is one of the co-authors of the study detailing how many clinics there are in the US. On his blog – The Niche – he recently expressed grave concerns about the Texas bills:

Paul Knoepfler

“The Texas Legislature is considering three risky bills that would give free rein to stem cell clinics to profit big time off of patients by selling unproven and unapproved “stem cell treatments” that have little if any science behind them. I call one of these bills “Right to Profit” for clinics, which if these became law could get millions from vulnerable patients and potentially block patient rights.”

Ziegler counters that patients have the right to try and save their own lives, saying if the Texas bills pass: “chronically ill, no option patients in the US, will have the opportunity to seek treatment without having to leave the country.”

It’s a debate we are all too familiar with at CIRM. Every day we get emails and phone calls from people asking for help in finding a treatment, for them or a loved one, suffering from a life-threatening or life-altering disease or disorder. It’s incredibly difficult having to tell them there is nothing that would help them currently being tested in a clinical trial.

Inevitably they ask about treatments they have seen online, offered by clinics using the patient’s own stem cells to treat them. At that point, it is no longer an academic debate about proven or unproven therapies, it has become personal; one person asking another for help, to find something, anything, to save their life.

Barring a dramatic change of policy at the FDA. these clinics are not going to go away. Nor will the need of patients who have run out of options and are willing to try anything to ease their pain or delay death. We need to find another way, one that brings these clinics into the fold and makes the treatments they offer part of the clinical trial process.

There are no easy answers, no simple solutions. But standing on either side of the divide, saying those on the other side are either “heartless” or “foolish” serves no one, helps no one. We need to figure out another way.

Here’s a Fun Lab Tour Video Contest for Scientists

Scientists are often stereotyped as serious, focused individuals who spend most of their time pursuing their science with little time for anything else. Their research often is complex and hard for non-scientists to wrap their minds around. I’ve often heard my friends describe to me what they thought I did every day when I was in the lab. It was like a science fantasy story involving beakers full of brightly colored chemicals, explosions, and at the end, a cure for Parkinson’s disease…

But I am going to tell you a little known secret: scientists are normal people like everyone else. They aren’t magicians with special powers, and they know how to have fun while doing their research. The problem is that the public doesn’t know this because they don’t have the opportunity to visit a research laboratory and see scientists in action.

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Paul Knoepfler

UC Davis Professor Paul Knoepfler is addressing this issue with his new lab tour video contest that he recently announced on his blog, The Niche. He’s asking scientists to make short videos of their daily lives in the lab and post them on Twitter with the hashtag #labvideocontest. The winner will receive a cash prize and “free PR for their lab”. The videos can be serious or funny, but Paul asks contestants to use their imagination and think out of the box.

This contest will not only be a fun way for scientists to talk about their research and what they do every day, but it will also benefit the public who will get an inside view of what it’s like to be a scientist. The goal of science communications is to make science relatable to everyone, and this video contest on social media is a great example of new ways that scientists can connect with the public and make science more approachable.

You scientists out there can learn more about Paul’s contest and how to participate on his blog. The deadline to submit lab videos is March 15th, so you better get to work!

And if you need a place to start, watch our recent video featuring the McDevitt lab, a stem cell bioengineering lab at the Gladstone Institutes.

Trash talking and creating a stem cell community

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Imilce Rodriguez-Fernandez likes to talk trash. No, really, she does. In her case it’s cellular trash, the kind that builds up in our cells and has to be removed to ensure the cells don’t become sick.

Imilce was one of several stem cell researchers who took part in a couple of public events over the weekend, on either side of San Francisco Bay, that served to span both a geographical and generational divide and create a common sense of community.

The first event was at the Buck Institute for Research on Aging in Marin County, near San Francisco. It was titled “Stem Cell Celebration” and that’s pretty much what it was. It featured some extraordinary young scientists from the Buck talking about the work they are doing in uncovering some of the connections between aging and chronic diseases, and coming up with solutions to stop or even reverse some of those changes.

One of those scientists was Imilce. She explained that just as it is important for people to get rid of their trash so they can have a clean, healthy home, so it is important for our cells to do the same. Cells that fail to get rid of their protein trash become sick, unhealthy and ultimately stop working.

Imilce is exploring the cellular janitorial services our bodies have developed to deal with trash, and trying to find ways to enhance them so they are more effective, particularly as we age and those janitorial services aren’t as efficient as they were in our youth.

Unlocking the secrets of premature aging

Chris Wiley, another postdoctoral researcher at the Buck, showed that some medications that are used to treat HIV may be life-saving on one level, preventing the onset of full-blown AIDS, but that those benefits come with a cost, namely premature aging. Chris said the impact of aging doesn’t just affect one cell or one part of the body, but ripples out affecting other cells and other parts of the body. By studying the impact those medications have on our bodies he’s hoping to find ways to maintain the benefits of those drugs, but get rid of the downside.

Creating a Community

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Across the Bay, the U.C. Berkeley Student Society for Stem Cell Research held it’s 4th annual conference and the theme was “Culturing a Stem Cell Community.”

The list of speakers was a Who’s Who of CIRM-funded scientists from U.C. Davis’ Jan Nolta and Paul Knoepfler, to U.C. Irvine’s Henry Klassen and U.C. Berkeley’s David Schaffer. The talks ranged from progress in fighting blindness, to how advances in stem cell gene editing are cause for celebration, and concern.

What struck me most about both meetings was the age divide. At the Buck those presenting were young scientists, millennials; the audience was considerably older, baby boomers. At UC Berkeley it was the reverse; the presenters were experienced scientists of the baby boom generation, and the audience were keen young students representing the next generation of scientists.

Bridging the divide

But regardless of the age differences there was a shared sense of involvement, a feeling that regardless of which side of the audience we are on we all have something in common, we are all part of the stem cell community.

All communities have a story, something that helps bind them together and gives them a sense of common purpose. For the stem cell community there is not one single story, there are many. But while those stories all start from a different place, they end up with a common theme; inspiration, determination and hope.