Our bodies, not our cells?

leftover-bloodDo we own our cells? Do we have some intrinsic right to them once they are outside our bodies?

One of the arguments I hear most often from physicians at stem cell clinics and some clinic patients is that patients have an inherent right to ownership and almost unlimited use of their own stem cells, but over the years my own reading on this issue has suggested that actually their assumptions are not necessarily the actual reality.

At that link above you can read about some pretty striking examples of where cell ownership was not clearly established. Think of the case of Henrietta Lacks and the cell line HeLa.

The argument from individuals on their ownership-based use of their stem cells was reflected in public reactions to the FDA too. One of the most common comments on the FDA online docket related to oversight of stem cells was “My cells are my cells”.

Are they really though by law?

There is in fact no universal, intrinsic ownership or right to one’s own cells or tissues once they are removed from our bodies here in the U.S. that I know of. I’m not aware of any federal law, for instance, that says Americans have broad ownership of biological materials once they are removed from their bodies. It’s also not in the Constitution.

For those who argue ownership and right to use their cells such as stem cells once removed from their bodies, I’d be curious to hear if you have any concrete evidence to back that up in terms of specific language to this effect present in actual laws. The key thing seems to be that once part of us such as our cells is removed from our bodies it ceases to be part of us even if it is later implanted back into us. That former cell/tissue of ours has become a thing instead, and in some cases it is now a commercial product, particularly if it is modified in any way.

Let’s look at some examples.

  • If you take the case of leftover blood samples in those tubes they use for blood tests on us, we do not seem to own those. In fact, as far as I know the medical organization that drew the blood probably owns those and can use them for research or other purposes if they are anonymized.
  • If you bank your blood prior to a surgery, then I’m guessing that you would own that blood and the institution holding onto it for you cannot take it away, but are there actual laws or legal cases addressing this?
  • If during surgery a physician removes a tumor or some normal tissue (e.g. fat, skin, etc.) in the process, as far as I know the patient does not own that material any more. It is routinely discarded or in some circumstances can be used for research.
  • If a physician at a clinic or other entity removes stem cells from a patient, I doubt that the patient has any claim of ownership of those stem cells unless otherwise specified in a document that they and the provider both signed.
  • If a party freezes gametes or embryos from IVF, then there would seem to be ownership there. Are there laws?
  • If a party freezes stem cells in a bank, there seems to be a presumption of ownership there, but is that spelled out in the contract?

So there are potential cases both ways.

However, outside of banked blood, banked stem cells or reproductive materials, what about other cells such as those isolated in a same-day procedure or stem cells stored by a clinic in a freezer without expressly being paid by the patient to do so? Even in the first three cases, is there cellular ownership expressly by law?

I don’t think we consumers definitely own our externalized cells in all or even most cases.

Now let’s be clear, I’m not saying that this widespread lack of cell ownership is a positive thing. I’m just saying it is generally the reality today. If we don’t like it, maybe we should work for a law that establishes clear ownership.

One might argue that even absent definitive ownership by patients of their own cells once those cells are removed from the body, patients should still have rights to use those cells or products made from them without interference from the FDA, but that’s not quite the same thing as arguing this kind of assertion from the basis of ownership. To argue for wide freedom of use of stem cells without oversight also has major risks.

So for you patients out there arguing your wide rights to your stem cells, give this a bit more thought and do some reading on it. It seems likely that in fact the stem cell clinics that you visit actually would have a good case that they own your cells or at the very least ownership is not yours by default. Of course, the use of biological samples for research has a very positive role in biomedical science, but ownership is a tricky issue.

The bottom line is that if you are going to argue “my cells are my cells” meaning ownership of extracted, externalized and sometimes processed stem cells, you need to establish ownership based on the law. If there are in fact laws out there conferring patient ownership on stem cells, I’d love to hear about them.

For another view on some of the same questions, see “Our Bodies, Our Cells” by Mary Ann Chirba and Alice Noble.

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.

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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?

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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.