√ What Should We Call “Stem Cell Clinics” Is “Snake Oil” Too Harsh For Some?

Is “snake oil” too harsh a term for some of what is sold at some of the worst stem cell clinics?

Is the phrase “stem cell clinics” itself accurate and useful in a broad sense?

When we read or write the phrase “stem cell clinics”, most people generally know what we’re talking about, but it is not a very precise use of language, especially these days with so many different clinics out there, and there is a lot of room for error. There are many kinds of stem cell clinics too so they don’t easily fit together under the umbrella of just one term.

Taken together, these naming issues represent a challenge.

A “stem cell clinic” might on one end of the spectrum be fully compliant and legit. It could be a CIRM-funded alpha stem cell clinic that is rigorous and follows FDA regs very careful or could be part of an institution that provides fully validated hematopoietic stem cell transplants related to blood cancers.

However, in the middle and on the other end of the spectrum a “stem cell clinic” would generally be a very different thing. It might infuse patients with any of a number of things loosely affiliated with “stem cells”: most commonly some gmish of cells extracted from your fat and processed supposedly to treat a whole medical dictionary’s worth of ailments. No FDA approvals at play here. Perhaps it’s a place that injects even animal stem cells or a non-living reconstituted powder extract from some baby’s amnion supposedly to “treat” aging or anything from head to toe…or it could just saline marketed as “stem cells”… or many other things.

In theory, we need a better name or names for these entities than just “stem cell clinics,” but it’s a challenge.

Over the years, some of us have tried out different phrases or nomenclatures for what might accurately but clunkily be referred to as “for-profit, direct-to-consumer, unproven stem cell clinics that lack FDA (or a similar agency, abroad) approvals.” While these various phrases we use more commonly have been shorter than my super long one above, they haven’t really seemed to fit the bill that much better than the long one and generally are less precise.

Here are some examples of phrases used in the arena and that I myself have used. Insert “stem cell” before “clinics” in each case below:

• “Dubious clinics.” This isn’t ideal because in many cases clinics aren’t “dubious.” For quite a few it is 100% clear that they are running afoul of FDA regs and have other major issues.


• “For-profit clinics.”  Most clinics are focused on making money off of patients. However, some people have rightly pointed out that many hospitals, biotechs, etc. are for-profits too. Still, one common feature of “stem cell clinics” is that they charge patients, whereas the clear majority of traditional clinical trials do not charge participants huge fees.


• “Direct-to-consumer (DTC) clinics.” This phrase might work…but in the “chemical” drug industry, DTC marketed offerings are generally FDA approved so this could be confusing. Witness the massive number of drug commercials on TV that are a form of DTC marketing.


• “Predatory clinics.” In many cases this is accurate as clinics take advantage of vulnerable patients including older folks and young families, but in other situations this is perhaps too harsh.


• “Unlicensed clinics.” This term reflects the lack of FDA approvals and licensing such as a BLA, IND, etc. but it may suggest to some that the care providers lack individual state licensing such as from medical boards, when often times the providers are themselves fully licensed (although not always and some aren’t physicians).


• “Non-FDA approved clinics.” This isn’t a bad phrase (and is similar to the above) and I often use it, but some clinics out there do not need full FDA drug approval (e.g. with autologous and homologous use of unmodified bone marrow), whereas others do need such approvals so it’s still arguably not ideal in some cases.


• Unproven clinics. I like this term even if it isn’t perfect. The point of this descriptor is that there generally isn’t solid, properly controlled data to back up what is sold at many stem cell clinics. This means that what is sold is unproven. However, “unproven” is kind of a vague term. Who decides what is proven? In science we rely on data and a community consensus over time.


• Snake oil clinics. Some clinics probably are selling basically snake oil, but this term carries a lot of baggage. If one is talking about a specific clinic, using the descriptor “snake oil” in the public domain might get you a threatening letter from a lawyer too.

So, what should we do?

What’s a good, concise way to refer to “for-profit, direct-to-consumer, unproven stem cell clinics that lack FDA approvals.”

One shorter combo is “unproven, for-profit stem cell clinics”. This nomenclature highlights the lack of rigorous data at almost all of the clinics and the focus on generating profit from patients for still experimental offerings, which again differs from traditional clinical trials.

Another option is just to stick to the simpler, most dominant present “stem cell clinic” terminology and for the rare instances of a rigorous, FDA-approved stem cell clinic (which are much rarer today), other adjectives could be added to its name for clarification.

I’m still on the fence as to the different options.

What do you think? Take our poll above. And if you don’t see what you think best, weigh in with a comment on the post.

Sumber aciknadzirah.blogspot.com

√ Stem Cell Treatment Poll Results: How Repeat Shots Boost Costs

One of the most common questions about stem cells is economic as patients ask about stem cell treatment cost. How much is the price tag? Empowered with information patients can start thinking like consumers and look out for their own interests more vigorously.

I’ve blogged and done polls before about how much patients self-report having paid per treatment, but another important factor needs to be part of this equation: how many stem cell treatments each patient gets.

For instance, if a patient reports paying $5,000 per treatment that may on its own send one kind of economic message, but on the other hand if they got 10 such treatments the cost would approach $50,000. Note that some clinics give discounts to repeat customers so it’s not always simple multiplication, but costs do ramp up with multiple therapies.

For this reason I recently did a poll (still open) asking people to indicate how many separate stem cell treatments that they’ve gotten. You can see an image of the current results of this poll at left. While the most common answer was “one” treatment, in total about 2/3 of respondents had received more than one treatment with the second most common answer being “two”. Interestingly, quite a few people appear to have gotten many treatments, with about one in eight respondents self-reporting 20 or more stem cell therapies. This not only amplifies cost, but also risks in my view.

Of course, internet surveys are usually not particularly scientific, but they can give a general snapshot of things, and if we crunch the numbers from this latest poll, the mean number of treatments was about two-to-three factoring in the percentages. If this is fairly accurate, then the average patient is paying about 2-3 times as much as was suggested in the older poll on cost per treatment.

There’s still also the question of whether certain clinics are properly informing patients that the typical customer gets (and pays for) multiple separate stem cell shots over a period of months or years.

Sumber aciknadzirah.blogspot.com

√ Polls On Futures Of Stem Cell Clinics Sued By Fda

Take our poll: what will be the fates of the stem cell clinic firms sued by the FDA one year from now in October 2019?

To be clear, I am asking for your predictions, not what you hope will be the situation a year from now.

U.S. Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center along with its parent stem cell clinic chain Cell Surgical Network were separately but in parallel sued in May by the FDA via the DOJ seeking permanent injunctions on what the FDA has indicated are non-compliant practices using unapproved stem cell drug products.

To my knowledge, these firms continue to sell the stem cells in question, which are adipose stem cell injections sometimes referred to as “stromal vascular fraction”. I also haven’t seen any indication that the firms are going to voluntarily stop what they are doing or that the FDA is aiming for a temporary injunction. Things have been awfully quiet on this front, at least in the public domain.

With this context in mind for today’s 3 polls, one year from today, what will be the status of these firms? Do they face similar outcomes? Will anything be different in October 2019 versus today? Will there be impact on California Stem Cell Treatment Center but not the whole big network that it leads? No change at all? What about USRM?

You can also weigh in on the polls or these situations in the comments.

Sumber aciknadzirah.blogspot.com