Kudos to Dr. Oz for stellar stem cell clinic show: time for more action

For me it’s been a wild week of grant and paper writing, grant review, going over data, and more, but finally I had a chance to watch this week’s Dr. Oz show on stem cell clinics in full last night and I give it an A+ grade.

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A show producer went undercover with an MS patient to a number of stem cell clinics and let the clinic people’s words do the talking about what’s most important to the clinics: money and not patients’ well-being.

The guests on the show included actor and MS patient Montel Williams and stem cell scientist Dr. Sally Temple, the President of ISSCR. They and Dr. Oz all did great on covering this issue. A special shout-out to Sally Temple for doing the show. Not many leading scientists are willing to put themselves out there to make a difference like that.

The show combined science, medicine, and compelling personal stories together with the undercover videos to expose the stem cell clinic industry for what it actually is: an endeavor almost solely focused on making money taken from vulnerable patients. It’s an industry that collects tens of millions of dollars from patients for experimental offerings that have little-to-no data behind them. No FDA approval.

And there have been bad outcomes ranging from deaths to blindness. Tumors.

If certain stem cells work and are safe for specific medical conditions, you must prove it scientifically and medically, and you have to do that first before you start marketing it. This means putting patients before profits.

Many biotech companies are doing exactly that and there are a host of promising investigational stem cell therapies in various clinical trials. Some will be proven safe and effective, which is so exciting! Others won’t work out. We can’t know the difference in advance of getting the data, but stem cell clinics are pretending they know their stuff works and is safe.

What do I say to patients who believe that the offerings of stem cell clinics do work?

Each of us understandably place great weight on our own individual patient experiences, but the experiences of one, ten, or even many more patients don’t prove things if they aren’t studied carefully with controls and in an unbiased manner. In biomedical science we learn that often, even if we are excited about an idea/hypothesis, once we carefully study our data collected from enough properly controlled experiments and it all gets examined critically by qualified colleagues, we end up being proven wrong. Sometimes we are right. The key thing is you have to let data tell the difference rather than hope or belief.

I appreciated how Dr. Oz issued a call to action at the end for his wide audience to tackle the major problem of stem cell clinics. We all need to work together on this. There’s going to be major positive impact from the show as a starting point to more action that involves the FDA, the FTC, and other governmental agencies such as state attorney generals and medical boards.

Yum or yuck? Test tube bacon from stem cells

test-tube-baconWait…test tube bacon?

Coming soonish to a BLT or breakfast near you?

An article in Nature’s Scientific Reports tells us that scientists have taking some first baby steps toward bacon or at least a meaty bacon-like product from stem cells.

Would you eat test tube bacon? Take our poll below.

One of the possible positives of test tube bacon is that it would give people meat to eat without killing pigs. Could be better for the environment too. Possible downsides include taste or sensibility issues…maybe even safety depending on the lab conditions.

The article, entitled “Enhanced Development of Skeletal Myotubes from Porcine Induced Pluripotent Stem Cells” has gotten considerable media attention (e.g. here).

The authors do seem to have food on their minds as it pertains to the outcomes from their paper such as in this concluding statement:

Thus, the molecular control mechanisms directing porcine skeletal muscle development have considerable implications for medicine, agriculture and food technology.

In a nutshell, the researchers used pig IPS cells to make myotubes, the main structural component of muscle, in a dish. Enough of these myotubes and you’ve got something resembling meat.

What’s missing?

How about the fat component that is so important to bacon’s texture and flavor? Note that I’m a pescetarian myself, but used to enjoy bacon now and then.

The notion of lab grown meat such as test tube burgers has been around for a few years now and I did a post on some hype about the lab grown burgers a few years back.

Cell Surgical Network, largest group of US clinics, using lab-expanded stem cells in patients?

Elliot Lander Mark BermanIs the largest affiliated group of stem cell clinics in America, Cell Surgical Network, now using laboratory-proliferated stem cells in patients?

Do they already have some kind of final FDA approval for this clinical approach given that lab-grown stem cells are generally viewed as drugs requiring premarket approval?

Over the years I’ve reached out to interview many members of our diverse community in the stem cell arena including those operating stem cell clinics. One past such past interview (here and here) was with the leaders of Cell Surgical Network, Drs. Mark Berman and Elliot Lander.

Even though more broadly those operating stem cell clinics across the U.S. and I don’t see eye to eye on many things, the interviews are valuable to the community, providing insights generally not otherwise found in the public domain.

Today’s post is a new, striking interview with Lander and Berman (pictured above). I invited them to do this short Q&A because there have been indications that their group of clinics may be gearing up to or already has been taking a different approach (at least compared to what I knew about in the past) to using stem cells in patients with the possible new approach involving laboratory-amplified stem cells.

For instance, on their website FAQ page they refer to using seemingly laboratory expanded cells (emphasis mine):

“Autologous lipo-aspirate can be frozen as SVF Stromal Vascular Fraction (contains mesenchymal and hematopoetic stem cells). SVF can be deployed for repeated treatments and also expanded under IRB approval as part of a safety trial providing vast quantities of autologous stem cells that could be used throughout that patient’s life.”

The question of lab expansion is such a crucial point because to my knowledge lab-expanded stem cells are considered a biological drug by the FDA requiring pre-market approval steps such as an IND, IDE, and/or BLA. Also, typically a safety trial of the type mentioned would be an FDA-approved, Phase I clinical trial based on an IND and I’m not aware of Cell Surgical Network having that.

To my knowledge, IRB approval alone is not a sufficient basis for doing a clinical trial on a biologic. Am I missing something here? Is Cell Surgical Network’s apparent IDE application with the FDA going to encompass data usually found in an IND as well? Why not do an IND and an IDE In this case?

The point of this interview was to try to clarify this situation. Thanks, to Berman and Lander  of CSN for doing it.

PK: I’m hearing that you are apparently growing adipose stem cells in the lab these days for clinical use (transplantation) in patients. Is that correct?

CSN: Yes – Our patients receive re-implantation (not transplantation) of their own cells under this protocol. 

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National Academies panel leaves door a crack open to future human genetic modification

Early human embryosA National Academies panel on human genome editing chaired by Alta Charo and Richard Hynes released its report today. While it covered both somatic and germline (heritable) human genetic modification, the latter topic is far more contentious. You can see the National Academies summary of their report here. You can read the full report here.

On germline genetic modification using technologies such as CRISPR, the authors of the report carefully discussed potential benefits and risks to the use of this technology. On my first brief reading of it, the report is mostly appropriately cautious in terms of outlining the potential risks as well as societal and bioethical issues in addition to potential benefits.

As to the more controversial area of potential human germline genetic modification, I appreciate the fact that the report unambiguously says that human germline editing is not ready to be tried and lists numerous hurdles to address first. However, although the report tackles most of the key considerations and risks (and for that the authors should be commended), there is still an interesting undertone to the report’s discussion that seems to strive to justify leaving the door open to potential future use of human germline editing.

For instance, the report makes a point of noting mostly hypothetical instances where existing technologies such as PGD that are far less controversial may hypothetically fall down and so possibly might need to be supplanted by germline editing using techniques like CRISPR, but such instances are now and in the future would continue to be exceedingly rare. Too much weight are placed on these.

The other point that needs to be made is that hypothetical future germline editing in human embryos (or even done earlier developmentally in, for example, germ cells) with reproductive intent would have to be preceded by a great deal of research that involves PGD-like testing of human embryos to monitor efficiency and specificity of editing, chimerism, and other issues so it is not as though germline editing could avoid PGD-related issues or destruction of embryos.

I’m also not convinced that the personal need by some individuals to have a genetically-related offspring should be a major consideration in decisions related to the permissibility of human germline gene editing. The related concept of parental autonomy is given too much weight by the report. While this argument has both aspects that intuitively make good sense, it also has some that could lead to promotion of germline modification.

For instance, what if parents want their kids to have certain traits that become potentially available via germline modification? In this regard, the ability of researchers and policy-makers both in the US and more globally to prevent parents and practitioners from going down the path to use germline human modification for traits rather than strictly health conditions may prove to be quite limited and it’s not clear had to address that risk. The report in some places does not use strong enough language to counter the idea of human germline modification.

On the whole, I have favored a moratorium on germline modification, a step that this report does not take. Of course there are possible problems with a moratorium too including enforceability (lack thereof) and that once you have a moratorium it might be hard to escape it (e.g. if the government follows suit with legal steps) even if down the road the science were to back up getting rid of it. Note that as the report mentions, for at least some months longer, in the US the FDA cannot consider applications for any human embryo genetic modification and then there’s the Dickey-Wicker Amendment that disallows federal funding of anything that involves ‘destruction’ of human embryos and such things as using CRISPR modified embryos to do PCR for research would qualify as destruction. But then there’s loads of private money out there for research as well.

What are your impressions of the report?

For more of my thoughts and concerns on human genetic modification you can read my book GMO Sapiens and watch my TED talk (below).

Dr. Oz Explosive Exposé on Stem Cell Clinics Airs Tomorrow

American stem cell clinics put thousands of patients at risk each year through hawking expensive, unproven and unapproved medical interventions, and now Dr. Oz is reportedly taking them on in a new show set to air tomorrow. dr-oz

Those running the clinics have affixed the buzz phrase “stem cells” onto a whole range of stuff ranging from A (actual stem cells, but unproven) to Z (zombie cells; aka not really living cells of the stem cell variety.)

While at times in the past the Dr. Oz Show has been criticized for how it discussed unproven health interventions, from what I can tell on the stem cell front now, they are very serious about exposing how risky the stem cell clinic industry has become.

A clip of the Dr. Oz show I was able to see in last week was striking. Another clip above from the show of Montel Williams is quite intense.

I was able to get this quote from Dr. Oz himself about this situation and the show:

“These stem cell clinics are using the potential of legitimate research to take advantage of patients desperate for help. These physicians are violating not only the trust of their patients but also the law and hopefully our show will push the FDA to use its authority to shut them down.”

I’ve set my DVR to record it. If you have any interest at all in stem cells as a patient, scientist, physician, student, grant funder, science writer, FDA person, FTC person, etc., you should check this out.

Dr. Sally Temple, President of ISSCR, is also on the show. I’m told that the stem cell clinic segment will be the second half of the show.