For a long time many of us in the stem cell field have been worried about dubious stem cell treatments, so-called ‘stem cell tourism’.
How do we stop it or at least fight back to keep people safe and help them avoid losing what is often their life savings?
Many activities related to stem cell tourism occur right here in the U.S. and almost entirely or entirely involve adult stem cells. Interestingly it is often the folks who are most opposed to embryonic stem cell research who promote expensive, untested and potentially dangerous adult stem cell research therapies. While they oppose embryonic stem cell research claiming it involves the lose of a “life” in the form of a few cell embryo, the adult stem cell research they push will inevitably kill an actual living, breathing person.
The International Society for Stem Cell Research (ISSCR), of which I am a member, had at one point launched a web portal through which anyone (patients, scientists, families, advocates, etc) would report their concerns about specific companies offering dubious stem cell treatments.
However, in the past year ISSCR shuttered this effort under the threat of litigation by the stem cell clinics that were offering the dubious stem cell treatments.
As a result many folks have lamented that the potential scourge of dangerous, non-vetted stem cell treatments might spread unchecked through the land.
What’s the solution?
With the steady stream of indictments and arrests by the FBI for stem cell-related charges in the U.S., it is clear that the federals government is taking a much more aggressive approach to the dangerous of stem cell tourism within the U.S.
As a result, I see a straightforward antidote to stem cell hucksters in the U.S. at least.
The solution–if you believe someone is breaking the law using stem cells, I encourage you to contact the FBI and tell them your concerns.
You may do so by going to this FBI tip site.
Stem cell related deaths or suspected deaths from un approved treatments. Here are some links. I believe all of these are would not be clasified as HESC but they are in the catagory of ASCs. All these cases of death do not mean the feild is not valid but they do point to the fact that proper research, animal testing and human trials are needed before these treatment should be allowed to procede. HESC companies have been trying to do things the right way. What has stood in their way have been RR oposition, short sellers, political pressure, EU court rulings, opposition of 21% to the use of Fedral funds for HESC, and current ecconomic uncertainty. How can a company develope HESC treatments currently when the EU will allow free access to their inventions that cost companies hundreds of million or billions to develope.
Taylor
http://www.reuters.com/article/2011/09/21/us-stemcell-scams-idUSTRE78K18120110921
http://www.wired.com/medtech/stemcells/commentary/spinalcolumn/2007/04/spinalcolumn_0411
http://www.newscientist.com/article/dn19056-death-revives-warnings-about-rogue-stem-cell-clinics.html
http://www.telegraph.co.uk/news/worldnews/europe/germany/8082935/Baby-death-scandal-at-stem-cell-clinic-which-treats-hundreds-of-British-patients-a-year.html
http://www.telegraph.co.uk/news/worldnews/europe/germany/8500233/Europes-largest-stem-cell-clinic-shut-down-after-death-of-baby.html
Taylor,
Your example from Wired magazine is out of range. The reporter misinterpreted data, therefore made false conclusions. His claim “Adult stem cells kill” is based on nothing.
In the whole 50-years history oh hematopoietic stem cell (adult stem cells) transplantation in hematology- oncology, we don’t have any evidence to claim “stem cell kill”. We we have a lot of evidence to proudly claim “stem cells cure!”.
Stem cell transplants are performed in “no other option” patients, otherwise dead in few months. Frequently it’s the only one option and it’s a curative option. We have many complications related to transplant procedure, but almost none of them are related to donor’s stem cell action and function. The major complications are infections due to severe neutropenia after conditioning (irradiation and chemo-). Graft-related complications, such as GVHD, cryoprotector (DMSO) toxicity, immune mismatch… have nothing to do with stem cells which are present in the graft. GVHD is due to mature donor’s T-cells, mismatch which cause graft failure is due to all leukocytes in the graft. So, the Wired reporter got all things wrong about it.
In terms of few cases of deaths in so-called “stem cell clinics” my take is the following:
We have no idea what people (let’s say “docs”) are injecting into the patients. I have no reason to trust any claims of deceptive marketing using “stem cell brand” to advertise and maximize a profit. Even if they use cells, what is the evidence that these cells are in fact stem cells? Now people call any cells as a “stem cells”, because it sells. Even docs, performing transplants of “total bone marrow cells” into the heart call it “stem cell therapy” with no reason for it and with no evidence.
So if “stem cell clinic” says “we are injecting stem cells” and mass media reporters say “they injected stem cells”, there is no any reason to believe them due to lack of evidence. Those clinics are not regulated, therapies are not proven, data are not reported, cells don’t have a “certificate of analysis” and so on. This is one of biggest misconceptions –
http://hematopoiesis.info/2011/09/08/stem-cell-misconceptions-therapy/
We are not lay public, we should talk on professional language and understand each other.
Therefore, I don’t see that we have enough evidence to claim “stem cells kills”. In regard of reported cases of deaths we can say “cells kills” if we confirm from those unregulated clinics that cells were actually injected. In hematology or oncology infused cells can kill (for example GVHD or gene-modified immune cells due to virus toxicity), but not stem cells.
The death in Germany was not from miss matching causing imumo response from the information given. According to XCell, about 25 British patients a month – including children with severe disabilities – are treated at its clinic in Düsseldorf and at another in nearby Cologne.
The treatment involves taking bone marrow from patients, harvesting stem cells from the bone marrow and then reinjecting those stem cells into other parts of the body, including the brain, the spine and the neck.
Forgot to mention I fully endorse your proposal to report schucksters to the authorities!
Paul,
I swore you must have listened in on a conversation I had just yesterday in which two of us discussed the nonsensical opposition many “adult stem cell clinicians” have to embryonic stem cell researchers. If they do so out of religious conviction that is one thing. But if it is done out of “my cell is better than your cell” type of motivation it makes no sense. I think part of it is that they believe ESC researchers are somehow “against” adult stem cell work which is, of course, not true. Any opposition to non-compliant ‘stem cell’ clinics is not against the cell type it is against bad science and clinical practices.
Having said that, I think we do a disservice to the debate and/or the opposition of such clinics to found the argument on the basis of “risk”. The facts do not lie. To the best of my knowledge, there is very little evidence of death from even the most egregious adult stem cell clinical practice whereas in contrast there are plenty of deaths each year from FDA-approved drugs, treatments and clinical trials. Similarly, the scientific concern over the risk of ESC-derived treatments is certainly considerably higher than ASCs.
That is no justification to allow such clinics to continue only a caution that the arguments, I believe, should be founded on solid factual footing.
In my opinion, this debate has far less to do with the risks associated with the cell type as it does with the risk associated with processing controls and clinical practices.
Whereas the primary risk related to ESCs relate to the cell type/origin, the primary risks related to ASCs center around potential contamination of the product, a lack of proper product/process controls, poor clinical practices, and generally a lack of safety or clinical evidence upon which we can safely assure patients regarding outcomes (positive or negative).
I have always appreciated your advocacy of this as “one field”, not ESC vs ASC, while at the same time supporting the fight against non-compliant clinics.
So it is this statement of yours that I hope you will rethink: “the adult stem cell research they push will inevitably kill an actual living, breathing person”. It’s not the cell type or the research that will kill, it’s bad science and clinical practices.
There are, of course, thousands of adult stem cell researchers who are doing their work in compliance with the scientific method and regulatory system we have built to try to keep treatments safe and effective.
There are also those researchers using both cell types who believe that the regulatory system we have built needs to be improved to allow research clinicians more freedom to provide treatments in a way which is good science, good clinical practice, but is offered in a way which the current regulatory framework does not allow (unless it is revised). This is an interesting debate that has much support from many circles well outside this field.
Thanks for all the great work you continue to do, Paul. Happy new year.
–Lee