Sacramento Nervana stem cell clinic spreads to San Diego

Nervana stem cellIt’s been an odd experience having a local stem cell clinic, called Nervana, here in Sacramento to watch in terms of how they handle things such as advertising. I’ve also heard quite a lot from people within our community asking about Nervana. Now the business is selling non-FDA approved stem cell therapies in San Diego too.

I’ve been concerned this year to see that our local paper The Sacramento Bee (SacBee) keeps running full-page ads (see the latest from this week above) for Nervana because I don’t believe there is a solid, medical or scientific basis for what they are selling. For instance, the notion that stem cells can be used to safely and effectively treat joint problems or neuropathy (things mentioned in ads) is debatable at this time.nervanastemcellsandiego

Another concern raised within the community is that at least some of the customers of Nervana may have received administrations of stem cell products from a nurse practitioner instead of a physician. I haven’t independently validated that. I’m not quite sure of how that is playing out in this case, but in my opinion only a well-trained physician who is a stem cell expert themself should transplant stem cell products.

The fact that Nervana now is recruiting patients in San Diego (see recent newspaper ad there at right; source California Stem Cell Report) for these non-FDA approved stem cell interventions amplifies concerns over potential risks for patients.

My understanding is that Nervana predominantly sells amniotic stem cell therapies. This raises the interesting question of whether the product in question is in fact stem cells (i.e. living cells) or an extract of amniotic stem cells. A great deal depends on the answer to this question in terms of FDA oversight, but also related to marketing as the ads to my eye suggest living stem cells are used.

The car shopping analogy for evaluating stem cell clinics

Patients contact me all the time these days asking about American stem cell clinics. The most common question boils down to “should I get a treatment at clinic X and what things should I think about in trying to make this decision?” I recommend checking out my stem cell treatment guide for patients.used-car-sales

In addition, you might consider an analogy to car shopping. I’ve found it is very helpful.

Buying a car is a much less serious decision than getting a stem cell therapy, but it is sometimes not taken as seriously from a practical point of view in terms of what goes into the decision making.

If you are going to buy a car ranging in price from say $10,000 (maybe a used Honda) up to $30,000 or even $50,000 or more for a car, you do your homework, right?

You read up on reviews and watch reviews online. if you’re like me, you appreciate balanced car reviews that talk about pluses and minuses.

You check out the specs on the car. You might talk to your own mechanic.

You go for test drives and you ask the car salesperson a ton of questions. You don’t necessarily believe their answers.

Also, you don’t take the claims about things like MPG at face value, especially after that recent emissions fixing scandal.

You go in with skepticism. You probable haggle on the price.

Take at least the same level of care (or hopefully much more) when considering a stem cell treatment, especially since we are talking about someone injecting you with living cells.

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Rick Perry’s Paid Board Position at Controversial Stem Cell Clinic Celltex

Rick Perry stem cellsIf you rewind the stem cell clock several years, the big news in the stem cell clinic arena was dominated for quite some time by a single stem cell clinic called Celltex in Texas in part because their most famous customer was Governor (at that time) Rick Perry. You can read the many past posts I’ve done on Celltex here.

Today the stem cell clinics are making news more for their sheer numbers (nearly 600 in the U.S. alone), but a few years back Celltex and Perry were stirring things up and getting noticed in large part because they were tangling with the FDA. Celltex and their former partner RNL Bio were cooking up a stem cell product that did not have FDA approval and the agency issued Celltex a warning letter. Perry was a supporter of Celltex.

Now Perry is more than just a supporter or patient of Celltex, he reportedly has a paid position on the stem cell clinic’s board. No longer governor nor running for president, perhaps Perry wants to devote more time to stem cells?

The Celltex of today remains a Texas business, but is selling stem cell treatments only (to my knowledge) administered across the border in Mexico. The change in clinical location was it seems an attempt to get outside the range of authority of the FDA. What will Perry’s actual operational role be? I don’t know. The AP got this quote:

“I’m a big believer in adult stem cells,” Perry told The Associated Press by phone Thursday. “My reputation is important to me and I want to be associated with companies I believe in.”

I actually met and talked with Governor Perry a few years back when Celltex was more on the radar screen and he was still governor. The meeting was down at Scripps in a meeting set up by Jeanne Loring. Several other physicians and scientists were present. He struck me as very excited about stem cells and eager to get businesses to move to Texas.

ABC News has this quote from Celltex on this development:

“Celltex CEO David Eller said in an emailed statement. “Given this passion, it is natural he joined the board of a premier U.S.-based biotechnology company that is known for its unparalleled adult stem cell technology now that he has left public service.”

I’m curious what the future holds for Celltex and every now and then I hear rumors of them potentially doing some treatments in the US or getting an IND from the FDA or something like that.  I did note that at least one of their patients spoke at the recent FDA stem cell meeting.

Anyone heard other news on Celltex?

Top 10 reasons for optimism on Stem Cell Awareness Day 2016

Happy Stem Cell Day!

It is a tumultuous time for the stem cell and regenerative medicine fields, but despite this there are concrete reasons for optimism on this Stem Cell Awareness Day. I’ve listed my top 10 below. What else gives you a sense of optimism? You can also check out CIRM’s nifty stem cell awareness day page too, from which I borrowed the below image.stem-cell-awareness-day-2016

  1. More trials = road to progress. There are more real, robust clinical trials than ever and they are progressing past the early phases in some cases. The trials are piling up and while not all will succeed, some will. Keep an eye open for the for-profit, non-FDA-approved ones and steer people away from those.
  2. We are seeing a flow of clinical trial data too pointing to encouraging outcomes, but also to challenges to overcome (witness the preclinical study on IPSC for heart attacks that found efficacy but also arrhythmias). With that kind of awareness such hurdles can be overcome in many cases as the work progresses.
  3. The FDA held public meetings on stem cells. We can grouch about certain things about these meetings and we can ding the FDA for various issues, but it never before has engaged with the community like this on stem cells so it’s a good thing.
  4. Stem cells firing on all cylinders: adult and pluripotent. Adult stem cell trials are building, but so now are pluripotent ones. The best way to help the most people in the long run is with all the tools (types of cells) we can utilize. The notion of “adult versus embryonic”, for instance, as some sort of cosmic battle seems out of date. We need both and also IPSC as well as other types as yet to come.
  5. The stem cell clinic problem out in the open. Never before has there been this much information and awareness out there on the problem of stem cell clinics taking advantage of vulnerable people. For instance, see my recent article with Leigh Turner and the one from John Rasko’s group. I believe awareness will translate into action for the positive.
  6. Putting the fun back in funding? NIH funding trends are looking at least slightly better overall which will help with stem cell research. CIRM is continuing its life extension and will fund many more projects in years to come. Other states are funding stem cell research too. It’s still a bad time for funding but the trend lines are at least moving the right way.
  7. Much more educational outreach on stem cells. When I started blogging about stem cells in early 2010 it was very quiet out there on the Internet in terms of those of us trying to educate a wider community in a positive manner. That’s really changed now with quite a few blogs that at least touch on stem cells and a number entirely dedicated to stem cells and regenerative medicine. This is a positive change and it means the public has more resources than ever to learn about stem cells.
  8. IPSC clinically-relevant work is looking up. It was a decade ago that IPSC cells were “born” and there were great expectations. Now 10 years later there are tangible signs that these cells will have lasting, huge impact including both from disease modeling and more recently via potential future clinical use.
  9. Stem cells meet CRISPR and…boom! Okay so everyone is nuts about CRISPR no matter what kind of cells they study including me, but CRISPR-Cas9 gene editing combined with stem cells in particular equals great potential both for new insights such as into human development and also potentially clinically through designer stem cells.
  10. Stem cell biotechs & stocks hanging in there. It has always been tough going for stem cell biotechs and that is likely to continue quite a while longer, but many are hanging in there and could surprise you down the road. Others have been acquired by pharma companies or inked collaborative deals in the last year or so. In the long run some of these companies are going to change medicine.

DNA Ahead Game & More Struts Its Stuff

Editor’s note: this is a guest post from Dr. Semenow on her new educational DNA game that also invokes stem cells. She has the remarkable distinction of having been the first woman who was a science Ph.D. student at Caltech. Stay tuned for my coming interview with her on her experiences in science. Her Kickstarter campaign for the game launches today.

By Dorothy Semenow, Creator of DNA Ahead™

DNA Ahead Game & More™ (the Game) tells the complete amazing story of DNA science and biotechnology. Its content emphasizes the “how” of the science, with pictures leading the way. Ambitiously, it aims to spur non-scientists as well as scientists of all ages and talents not only to understand and apply science findings in their own lives, but also to create science-based products and performances that spread science savvy.

I knew from my work as a psychologist/educator and my experience in the 1960s-70s women’s movement that the Game needed to occupy common ground on which to connect with its users. I took my cue from early childhood learning when play and pictures reveal the world, and chose a board game format featuring picture cards—the equivalent of a map and a picture book, but more flexible.

Fifteen years in the making, the Game blends the major chords of my life—projects, arts and crafts, science, mastery-by-teaching, underdog and creativity boosting; and, throughout, bridging.

The Game Art stars in the Hands-on Picture Science (HOPS) approach used to motivate users to explore the remarkable history and sweeping effects of the DNA revolution—AND communicate what they learn. Indeed, the Game’s effort to activate the inner teacher in all of us is its other key feature. HOPS bridges science to the arts (STEM —> STEAM), and its usability with any group anywhere makes it a worthy supplement to hands-on science lab and field activities for both non-scientists and scientists.

Here’s how it all works, starting with the Game Board. In a way that words alone cannot convey, the Board’s pictorial map depicts the relationships between the early history of genetics unfolding chronologically (in the RIM), the tools that launched and advance both DNA science and the biotech revolution (in the center HUB), and the biotech areas that have resulted (in the 8 HELIXES fanning out from the HUB). The last include Spaces for controversial issues—e.g., labeling of GMOs and stem cell research on human embryos. Quite apart from game play, pictures on Board Spaces invite users to think about their possible meanings, based only on the pictures and their titles.
Female mammoth DNA Ahead

The Game is fun to play and, for each round, you can choose targets that determine its approximate length and the content areas favored. You don’t need to know any science to play, and you don’t need to play to benefit from using the materials. They’re designed for use apart from play by both players and non-players.Let’s say you choose to play the game and have read the Rules in the All-U-Need Booklet and/or watched the How To Play & Navigate Content Video. You’ll roll Dice, move around the Board, land on and claim Spaces, and draw their Claim Cards, all like Monopoly—but with more Move options plus Consequences on frequently drawn  Whoops-Or-Whoopee (WOW) and issues-insights-innovations (iii) Cards, which introduce many more choices and strategic possibilities.

The WOW AND iii Cards also introduce small bites of content, so you can decide what interests you. WOW Cards cover the subculture of the scientist tribe, aka “the human side of science,” (career counselors, take note), while iii Cards focus on just what their name says, as applied to DNA science and biotechnology frontiers.Gene pick

Some WOW and iii Cards in both Decks report on topics you’ll likely find personally relevant—e.g., “Exerciser or Couch Potato in Your Genes?” and “‘Fast Sleep Gene.” Many such Cards carry icons pointing to Claim Cards that flesh out their subjects. And Cards with content by, for, or about groups underrepresented in science carry identifying icons. 

Most important, Consequences lead to Show-&-Tell (S&T) Cards that guide you to apply relevant concepts to your own life and use your talents to create products or performances that express those concepts. The DNA Ahead exhortation is: “Teach—i.e., cogitate/create/circulate/celebrate—to master the science and inspire your audiences to do the same.” 

DNA Ahead is very content-rich as games go. But at heart it is just a little game trying to make a few big waves. To do that, the challenge is to connect with users on their own turfs, to convince them that their creative contributions to spreading knowledge about DNA science and biotechnology can both contribute to the personal sense of purpose we all seek and fill a vital need in the larger world. 

The Kickstarter crowdfunding campaign, with its emphasis on community, provides an ideal setting to launch the Game. But that is just the beginning of the real campaign in which future forums and activity invitations on the website will aim to inspire a vibrant team who creates and tests a variety of improved versions, spin-offs, and free-flyers. At age 86, I must scurry to kick off fulfillment of these grand plans. All hands aboard are heartily welcomed!