The Subversion of Stem Cell Therapy in the United States

Walter P. Drake. October 1, 2019.
The best stem cell therapy is still overseas.

And stem cell therapy in the US, applied routinely overseas to cure and control our most debilitating diseases, is being subverted by powerful forces bent on requiring the use of expensive off the shelf products that can be “dispensed” like drugs. In the US, we now have stem cell “banks”… typically cells in storage that have been grown in the lab…but not a single report demonstrating any benefit from using them!

18 years ago when I started my study of the field, the idea was to take 25-50 ml tube of patient’s blood, expand the stem cells ex vivo (multiply them), and re-inject into the patient. This was the dream to make this therapy available to EVERY physician in an office setting. At that time, we only lacked one piece of equipment, the expander machine for which one of our graduate graduate students built a prototype. This can easily be packaged into a coffee maker size machine. With some funds I and anyone else could easily figure this out.

There are not enough stem cells in 25-50 ml of peripheral blood to cause a therapeutic effect without expansion in most cases. With the FDA blockading the “expansion” route, the next new idea was belly fat and the 400x more stem cells one could get that might substitute for expansion. While this procedure has wide application in Thailand, Mexico, and most other countries, this is going to be squashed in the US.  And anyway, harvesting cells via liposuction eliminates most individual physicians from using this “new medicine”…it is not as easy as obtaining a tube of blood!

What does the US want? They want the pharmaceutical companies selling off the shelf cells to you from various cell banks. They want to adulterate true cellular therapy, and twist it into use of off the shelf products suitable for everyone…like “drugs”. Cells off the shelf is not patient-specific therapy, nor is it what stem cell therapy was contemplated to be. Wait till all the labelling of the cell products comes along, and all the rules as to which condition you can use these for. Patients will need a prescription to obtain expensive off the shelf cell products in storage. And it will be expensive, very expensive, compared to the cells we have circulating in our bodies for free.

If you take a look at developments in stem cell banking, you may run across the University of Utah School of Medicine with their behemoth program  of culturing and storing induced pluripotent stem cells (iPSC’s) from which  they can make any kind of cell  in the lab. An excellent lab to be sure, they can take these lab-created cells, and with even more manipulations, create cardiomyocytes for direct injection into the heart for treatment of cardiac disease. They have whole buildings devoted to this development. Theoretically, these products would become available for purchase by physicians for use in treating their patients. To my knowledge there is not one paper showing that iPSC’s from any bank demonstrated any beneficial effect for ANY disease or condition. And most physicians, I would think, would prefer to use fresh stem cells from their own patients at a much lower cost. It would seem that banking stem cells rather than using the patient’s own cells, leads to unnecessarily complicated and expensive procedures where none are needed.

Back to cardiomyocytes, Did you know that 20 years ago in Thailand, autologous stem cells from a patient’s peripheral blood were expanded ex vivo in Israel, shipped back to Thailand,  and implanted directly into a patient’s heart with EXCELLENT results. You do not need to make cardiomyocytes first, the injected stem cells BECOME cardiomyocytes because cellular environment is the number one determiner of differentiation!

20 years ago!

And Thailand is still successfully treating cardiac patients, only now they are not expanding peripheral blood, but using cord blood and placental tissue from healthy newborn births:

Are we doing this in the US?  Nope. Amazing treatments are routine everywhere except in the US.

Another ongoing development is the important US website of Cryocell International, which banks umbilical cord blood and tissue.

What is amazing…they list every disease you ever knew, including spinal cord injury, as being treatable with umbilical cord stem cells (same ones Neil Riordan uses in Panama). Of course, due to their business model, they suggest only donor or sibling can use, not realizing these products are immune-privileged and can be transplanted to anyone!!!!!!!!!!!! But WOW what a terrific, thorough list of proven treatable conditions!!! So, although they demonstrate fully how effective umbilical stem cells are, in the US, treatments not available.

Then we come to this example website of a physician in Utah using umbilical cord blood apparently from donated placentas to treat MS:

This is what individual US physicians should be doing, since expansion of peripheral blood is out, placenta/cord blood (the after birth) is a fairly obtainable source of stem cells, and can be transplanted or injected IV to any patient with no immune rejection or other bad consequences.

And one of the greatest reviews for using Umbilical Cord Blood stem cells for most diseases is from this California clinic:

So you have on the one hand the giant developmental projects like at the Utah Medical School trying to safely bank laboratory grown induced pluripotent stem cells,  “dispensable” just like the FDA wants (and surely expensive) with no record of any efficacy, or at least not in any treatment pipeline that I can find.  And I don’t see many physicians in the know going for this.

And then on the other hand we have Cryocell…banking umbilical cord blood and tissue like gangbusters, proving by cited papers worldwide how the product injected IV cures EVERYTHING, but they can’t sell any product to physicians because it is privately owned by donors!

And a lone physician obtaining placental material on his own via donation I assume, and treating Muscular Dystrophy.

I would also like to remind everyone that menstrual blood is easily harvested, has the same properties as umbilical cord blood, and can be transplanted to any patient without immune consequences. Women could be paid to collect their menstrual blood which could then be screened for viruses similar to blood banks, and then be available to individual physicians for stem cell therapies.

Will any of these beneficial approaches be implemented in the US?

Not likely when you consider that the law passed by Congress over 3 years ago, the 21st Century Cures Act, authorizing stem cell therapy in the US, has been largely ignored by the FDA and has not been implemented.

The favorable turning point we had hoped to see with the passage of the new law, has not materialized, and we can safely say at this point, that any reforms beneficial to patients,  are nowhere on the horizon.


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