√ Animated Map Video Shows Wildfire Spread Of Us Stem Cell Clinics Lacking Fda Approval

There are now so many clinics selling non-FDA approved stem cell offerings across the U.S. that tens or hundreds of thousands of patients are at risk. How did we get here?

What if we had a way of understanding how stem cell clinics spread across the U.S. in the first place? For example, an animated map showing the spread of stem cell clinics selling non-FDA approved “treatments” across the U.S. would be useful. With publication of our new paper, the recent work of Leigh Turner and I provides just such a map (also see video below).

When Leigh and I published our 2016 Cell Stem Cell study showing almost 600 stem cell clinics selling non-FDA approved offerings across the U.S., many people were surprised at the extent of this for-profit, direct-to-consumer clinic industry in America operating without FDA approval. The first question many readers asked me was similar, “Where did all these clinics come from and when did they first pop up?” The same kinds of questions arose from the piece that came out just a bit later from a team led by John Rasko.

Our newly published Regenerative Medicine paper including the animated map provides a compelling visual answer.

Knoepfler & Turner, Regenerative Medicine 2018

As of 2008 we didn’t find evidence in Internet archives of stem cell clinics marketing on the web. Within the first few years after that there were just a handful of clinics (see screenshot above of 2010) and the early ones were in California, Florida, Texas, and Colorado, but in subsequent years their abundance exploded across the country. In just the last few years, about 100 or more new clinics have popped up yearly on the web leading to today’s seriously problematic situation.

A good portion of this wild growth of clinics selling potentially risky stem cells is attributable to lack of FDA oversight actions in past years along with aggressive expansion efforts by many of the clinics and clinic suppliers to raise profits by spreading in a way reminiscent of franchising. Imagine if the Obama FDA had taken some substantial action in 6-7 years ago on the non-compliant clinics? I doubt that we’d have the scope of masalah that we have today. Leigh, I, and others have been pushing the FDA for a very long time to act, but without much luck.

Will the new Trump FDA more actively and successfully rein in the clinic industry so less risk is posed to patients and the stem cell field overall? So far what I’ve seen is hopeful signs, but it’s a huge task that the agency has indicated they may not have the bandwidth to tackle in total. Still, the FDA needs to do relatively more and I’m hopefully they will. Even acting on say the top 20 firms that the agency views as the highest risk could have a positive domino effect.

In our new paper, Leigh and I also found that clinics marketing certain conditions and types of stem cells exhibited specific trends over the years. For instance amniotic stem cell clinics, while lagging behind bone marrow and fat stem cell clinics in numbers, show a sharp upward trend. This spike fits with increasing mainstream media advertising efforts by amniotic clinics.

While Leigh and I documented the nearly 600 clinics as of 2016, my sense is that there are likely to be upwards of 700 clinics today. What will the map of stem cell clinics look like in 2019 or 2020? What do you think? Fewer? More? Or about the same number of clinics? What would similar temporal maps of clinics in other countries look like?

The research we’ve done and published in the last few years hopefully will provide a foundation for future efforts to get additional hard data on the for-profit stem cell clinic arena including the direct-to-consumer marketplace that in my opinion poses the highest risks both to patients and the stem cell field.

Sumber aciknadzirah.blogspot.com

√ Clinic Versus Clinic? Internecine Conflicts Among Direct-To-Consumer Stem Cell Firms

Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx very strongly and publicly criticizing a firm called Stem Cell Institute of America.

Screenshot from the Regenexx blog, circles added by me.

Centeno is vocal on his Regenexx blog about stem cell-related various issues. He is outspoken in other ways too and my impression from his comments over the years is that he’s not exactly a fan of academics like me who weigh in on stem cell clinics. Interestingly, lately some of his posts have included strong criticism of other stem cell clinics including especially Stem Cell Institute of America, which is involved in the marketing of amniotic stem cells via scores of “partner locations” that seem to be amniotic clinics selling to consumers in this case. For example, you can see this strongly worded review of Stem Cell Institute of America by Centeno back in 2016 subtitled, “Chiropractic Amniotic Bait and Switch.” The Philadelphia Inquirer described his criticism as “blistering”:

“On his blog, Centeno has written blistering critiques of chiropractor-run stem-cell enterprises, particularly Stem Cell Institute of America, a Canton, Ga.-based firm that shows hundreds of “partner locations” on its online map.”

Already in 2018 Centeno has also done other posts on Stem Cell Institute of America and raised questions about a new “documentary” film series that apparently promotes unproven stem cell offerings including adipose stem cells (see screenshot above from his blog).

In fact, Centeno has what seems to be his own investigational type video (see above on YouTube) that asks the provocative question, “Is this stem cell fraud?” The video using the word “fraud” even in the form of a question is surprising and has certain risks attached to it.

I asked Centeno by email why he has stepped up his challenges to certain clinic-related businesses on his blog as well as via his video, and why he’s critical of the chiropractic amniotic stem cell area. Here is what he wrote back:

“Orthopedic stem cell therapy using bone marrow concentrate (BMC) has gained a reasonably large following with academic physicians at Stanford, Mayo, and Emory all offering this as a treatment for MSK conditions outside of clinical trials. Hence, it’s close to the point of gaining enough academic street cred to transition into common use. The chiropractic and amniotic “stem cell” trends threaten to take a serious field with mounting evidence and turn into an alternative medicine “pixie dust” therapy. This damages the credibility of orthopedic BMC use.”

Strong words.

So what’s Stem Cell Institute of America’s take on this situation?

I emailed to ask Brent Detelich, who is in a leadership role at Stem Cell Institute of America, for comment on Centeno’s various criticisms on his blog, etc. and got back a few emails from the organization with some critical words for their critic, and this comment for The Niche:

“All Clients of the Stem Cell Institute of America have the purpose to educate patients about all forms of stem cell therapy, including adipose derived MSCs, bone marrow derived MSCs, human umbilical wharton’s jelly and other types of treatments such as PRP and Amniotic Tissue Matrix.  Amniotic has a particular quality of cells and growth factors which create healing activity.  The Stem Cell Institute of America does not dictate which choice of the above regenerative therapies it’s clients chose to use with their patients. The decision of which regenerative choice is best for each individual patient is a medical decision and not the place of a consultant.  The medical decision of how they diagnose and treat each patient lies with each office’s medical team. These medical decisions are only made after complete history, consultation, examination and any necessary X-rays or MRI studies are done.”

I have a feeling we haven’t heard the end of this story.

To be clear, I’m not taking sides here in this specific situation. Over the years I’ve been skeptical generally of “amniotic stem cell” offerings and adipose stem cell “therapies”, but I’ve also asked questions about some of what Centeno and Regenexx clinics are or were doing with bone marrow cells (e.g. I reviewed a paper of his here and noted its hard to interpret the data due to lack of control subjects.)

More broadly, why would those in the for-profit direct-to-consumer clinic sphere (clinics themselves and affiliated businesses) seem to be more often in conflict with each other? One factor is that it’s getting crowded out there. You can see data on the spread of new U.S. clinics in the recent paper from Leigh Turner and I here.

Also reflecting a cramped direct-to-consumer clinic sphere, I’ve noted that many of these firms including Stem Cell Institute of America (see Seattle Times ad for them) are now using mainstream media ads for non-FDA approved offerings. These ads are very expensive so the firms must think it’s worth it to get consumers aware of them.

Another possible explanation for clinics getting into it with each other is that certain businesses may be firm believers in their own approach (e.g. one specific kind of stem cell type or methodology) and view other stem cell offerings with skepticism. Certain firms may be concerned that others that they view as problematic in their opinion could give their field a dent to its reputation overall.

It’s also worth noting that some stem cell clinic firms are going the opposite direction and linking up together, even as others are in conflict.

We are likely to see more examples of direct-to-consumer stem cell clinic businesses butting heads with each other in coming months and these situations may provide new insights into the overall direct-to-consumer stem cell clinic dynamic.

Sumber aciknadzirah.blogspot.com

√ Top 10 Takeaways From Unique North Dakota Action On Stem Cell Clinic

Screenshot of online video featuring Jones and talking about stem cells.

Hat tip to North Dakota!

You probably know by now that there are stem cell clinics in just about every state in the U.S. and some states and metro areas are hot spots. Heck, some of you reading this probably run such clinics. But did you know that of all the states, arguably North Dakota has handled a stem cell clinic situation better than any other so far? And this has big implications for stem cell clinics across the U.S. You can see my top 10 takeaways from this further down, but first some brief background.

Late last year it came to light that there were alleged issues at a clinic offering stem cells in North Dakota called West 2 Medical Solutions. The clinic had been offering the stem cells less than two weeks before the alleged concerns from patients arose it seems.

Now just a few months later the state of North Dakota, including specifically its consumer protection division, has reached an agreement with West 2 Medical Solutions in which the company will pay more than $20,000 including just under $20,000 going to former customers who wanted refunds, according to the Grand Forks Herald. The firm will also stop offering the stem cells in question, which appear to be marketed as amniotic stem cells. Note that the parties in the North Dakota case still deny the allegations even after coming to a settlement with the state.

Here’s the state’s take on how this wrapped up:

“For us, it’s mission accomplished,” said Parrell Grossman, director of the Consumer Protection Division. “We needed to stop these injections due to our concerns about the misrepresentations and any potential adverse consequences, and otherwise make sure the clinic can engage in other forms of medical treatment that is in compliance with federal and state law.”

The way that North Dakota handled this was striking and below are 10 take-homes from this situation for other stem cell clinics more broadly as well as those following developments related to them.

1. Amniotic stem cells are not somehow immune from regulation. This type of offering is widely marketed now today in America and it is not necessarily FDA compliant. Even if some clinics feel there is wiggle room there, if a state agency disagrees, the clinic may still find itself in an unfortunate situation. From the newspaper article, “The stem cell injections in question were amniotic tissue, called allograft, injections, Grossman said.” My understanding is that isolated living cell, allogeneic amniotic transplants are almost always going to be drug products according to the FDA requiring premarket approval. If what you are selling is not living amniotic cells then you shouldn’t be marketing it as “stem cells”. Also, for you fat stem cell clinic folks, remember the FDA’s simpulan guidance said SVF is a drug too.


2. You personally as the owner of a stem cell clinic may end up having negative consequences from what you are offering depending on how things go with your patients. From the Herald, “West 2 Medical Solutions owners Dean Jones, of Colorado, and Terry Guthmiller, of Bismarck, must refund $19,733 to patients, as well as pay $4,000 in civil penalties, attorney’s fees and other costs to the attorney general’s office.”


3. Even non-owners such as nurses may have risks from working at a stem cell clinic. Let’s say you don’t own a clinic, but you just work at one as a nurse or other health-care provider, we see here that even so you may also be liable in some way if patients are unhappy overall. From the Herald, “Landsiedel and Watkins, who are licensed nurse practitioners in the state of North Dakota, must each pay $500 to the attorney general’s office. Grossman said they negotiated separately with them because they no longer work at the clinic.”


4. Even just a few unhappy patients can have big impact.


5. Don’t screw around with investigators. If a state or federal agency starts investigating your stem cell clinic, you should probably cooperate. In the North Dakota case the clinic apparently was very cooperative it seems so that in my view that was wise. Reportedly things could have gotten more serious if the clinic personnel weren’t so cooperative. From the Herald, “Because the clinic leadership and its employees “fully cooperated” with the investigation, Grossman said the attorney general decided against pursuing a formal filing of a consumer fraud action.”


6. Fraud investigations against stem cell clinics in the U.S. are possible. See quote in above item.


7. As a clinic, you don’t just have to think about the FDA, you should think about state regulators too. Keep in mind that the Federation of State Medical Boards will be releasing its report on stem cell clinics in a few weeks and that document is likely to spark stepped-up state actions on clinics. From the Herald, “”The attorney general’s office, themselves, have taken the position that the products we were using were not compliant with the FDA, and so, accordingly, we just agreed to refrain from using those products,” Jones said in an interview Tuesday.”


8. No stem cells are risk-free and so you must clearly consent patients on risks. Using even some types of stem cells that at times are portrayed by certain firms as not having substantial risks, can lead to problems either from the cells, the procedure or both (or even some other random factor). From the Herald, “At least one patient indicated to the attorney general’s office that there was pain in both knees after receiving the injections.” I don’t know if the North Dakota clinic mentioned more pain was a possible side-effect or not.


9. Regulators can act fast. While some state or federal agencies tend to be seen as slow to act, this North Dakota case proves fast action is possible. It took just a few months from the time of complaints to simpulan state action here.


10. The liability could be in the millions for some clinics. Some clinics have stated publicly that they’ve injected stem cells into thousands of customers. In the North Dakota case, the clinic had to refund the payments back to just a few patients, but it still added up fast. For other clinics with hundreds or thousands of past customers (each having paid thousands or tens of thousands of dollars per treatment), state or federal action could end up with firms having to pay millions of dollars back to patients and/or in regulatory fines.

I hope other states will be as effective as North Dakota in handling their stem cell issues.

Sumber aciknadzirah.blogspot.com

√ Fda Recalls Liveyon Stem Cell Product: Blow To Big Clinic Supplier?

The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.”

An emerging big player in the birth-related stem cell clinic area?

I’ve been hearing the name Liveyon pop up more often in the unproven stem cell clinic industry recently. More specifically, they seem to be a supplier and marketer of birth-related products to clinics. The clinics then in turn inject the non-FDA-approved offerings into customers for profit. I have only mentioned this particular company once on this blog before. It was in a post about a clinic that apparently used their product for neuropathy, which was not a recommended indication.

Screenshot of part of LIVEYON homepage

The birth-related stem cell clinic industry more broadly has really taken off the last few years and now constitutes a sizable slice of the clinic pie across the U.S.

Liveyon has been part of that growth.

Umbilical cord stem cells + growth factors

The company’s splashy website (see image of part of the homepage) focuses on umbilical cord “stem cells”. I’ve never really been clear as to whether the products of this supplier and others in this birth-related area including amniotic materials actually have living cells or are just dead extracts (see my past post Wanted Both Dead & Alive).

From the Liveyon website:

“Liveyon provides high-quality, medical grade umbilical cord cells and growth factors for use in research studies for various degenerative diseases. By combining stem cells and growth factors, our product may give a longer lasting effect and improve quality of life for those suffering from debilitating diseases/ disorders, such as arthritis and orthopedic indications. Our product testing makes you, the skilled practitioner, feel comfortable that your patient is receiving the best product available in the market.”

This sure implies living cells. What are “medical grade” umbilical cord cells? Hard to say.

If the cells are indeed living and because they seem to be mixed with growth factors, in my opinion it would seem this product would require a cleared FDA IND prior to marketing or use in patients. I suppose the company could have an IND, but I strongly doubt it.

Thinking about the recall

What specifically made the FDA recall the Liveyon ReGen product series?

The FDA notice says, “Consignees were instructed to not use the vials, due to reported adverse reactions.” More broadly, I have heard of some apparent adverse reactions to birth-related “stem cell” products through the grapevine, but I haven’t confirmed any or gotten many more details. I wish we knew more about the adverse events here. Maybe we will learn more later.

The FDA verbiage suggests to me that Liveyon isn’t the manufacturer of its products, which is instead attributed to another company Genetech, Inc. (not to be confused with the well-known biotech, Genentech). I’m not sure what Genetech’s story is, but a different site suggests that they have 12 employees, $8 million in annual revenue, and that they also manufacture antibodies.

Looking ahead

Does Genetech send the same or similar products to other clinics and are those products of concern too?

How many people were injected with Liveyon’s recalled product? Will they have their health monitored? Again, what exactly were the adverse events and how many occurred?  I used the Liveyon’s “contact us” online form to ask these kinds of questions. We’ll see if I get a response.

Who runs Liveyon and are they some kind of expert? A physician? A highly experienced stem cell scientist? What do they have to say about this recall? Stay tuned.

Finally, I am curious as to whether the FDA will do anything more about this situation.

Sumber aciknadzirah.blogspot.com

√ Sales Of ‘Zombie’, Birth-Related ‘Stem Cells’ Continue To Mushroom

The birth-related stem cell clinic industry is a serious dilema for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections.

One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was predicted by the data that Leigh Turner and I published in one of our collaborative papers in which we saw an upward slope in the number of businesses selling amniotic or other birth-related “stem cells”.  By “birth-related” I mean amniotic, placental, umbilical cord, or other products that result from the birth of a new baby.

The numbers were still very small at the time of our study, but the ekspresi dominan was clear. Still, at that point I wouldn’t have guessed that we’d find ourselves in early 2019 with a massive number of clinics selling birth-related “stem cells” from coast to coast. There could easily be 100-200 of these clinics or other individual practitioners selling this stuff. Why the big growth here? Suppliers and marketers are driving the expansion by convincing chiropractors (and some physicians) to sell their unproven and non-FDA approved products.

I speculated in a post “Wanted Dead & Alive” a couple of years back that some for-profit clinics and suppliers in this area are selling products that aren’t really living stem cells (they are “dead” extracts), but they still market the products as both living and stem cells. Hence, there’s my opinion that this is a “zombie” kind of thing.

To be clear, some birth-related products (when not in vague “zombie” form, but instead produced in appropriate clinical-grade facilities by experts and validated to contain living cells of defined types) are promising for certain applications and are being studied in many clinical trials, but should not be sold today.

There are big, unanswered questions here. For instance, where do the birth-related products come from? How often are they either be contaminated or have not been probably tested for pathogens? Do the new mothers know that the materials from the births are being sold and possibly resold? Is it possible in many cases mothers have not consented to the use of the brith-related materials?

Also, could some of the products sold in the US be produced from overseas births? I have heard this is likely the case for some suppliers, but I haven’t seen concrete evidence of this. The lack of clarity about the sourcing and validation of birth-related products being widely injected into patients is very worrisome.

For instance, in the last few months we learned that 12 people were reportedly hospitalized due to contamination of a birth-related product being marketed by Liveyon and apparently produced by another firm called Genetech (not Genentech). Somehow the product became contaminated (or was contaminated to start with?) with various kinds of bacteria before it was injected. Fortunately for other potential patients, the product was recalled by the FDA.

This doesn’t seem to have made much of a dent in this birth-related “stem cell” clinic sector so far, but we’ll see. There also have been at least two and perhaps more patient lawsuits against firms in this area. I expect that number is already growing and that could rein things in somewhat too.

The FDA needs to get moving in this area since the products are marketed as living cells, which in allogeneic form and often used in a non-homologous manner would be unapproved drug products. If there are no real living stem cells in most of these products as many of us suspect, then the FTC needs to take some action here quickly too.

Paradoxically chiropractors are the primary ones selling birth-related ‘stem cells”, even though they themselves cannot legally inject them. In my opinion, these chiropractors pitching stem cells are essentially working with suppliers and physicians to just extract more money from their client base, without a reasonable expectation of benefit to the customers and with definite risks. Chiropractic associations needs to take some kind of major action here.

Overall, how do we get out of this zombie, birth-related “stem cell” mess?

The possible solution seems to be a combination of educational outreach to patients/consumers and bold action by multiple levels of regulators. It’s not encouraging that in the fat stem cell clinic arena, which is even bigger as well as being years older, and has some major problems of its own including hurt patients, we haven’t seen this kind of big impact yet by regulators.

Sumber aciknadzirah.blogspot.com

√ Ftc Returns Half A Mill To Consumers Of “Deceptively Marketed Amniotic Stem Cell Therapy”

There’s a lot of questionable “stem cell” injections these days involving purported amniotic stem cell or other perinatal (birth-related) material. Regulators are taking note including the FTC, which took some unprecedented action last year on this front.

Now the FTC has announced that more than half a million $USD have been returned to consumers who got dubious “amniotic stem cell” material.

From the FTC announcement:

“According to the agency’s October 2018 complaint, Dr. Bryn Jarald Henderson, D.O. and the companies he owns and operates, Regenerative Medical Group and Telehealth Medical Group, deceptively advertised that their “amniotic stem cell therapy” could treat serious diseases, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart disease. The defendants lacked the scientific evidence needed to support these claims.”

I’m wondering where the FDA’s CBER is on this front too because true living amniotic stem cells used in the kind of manner described above would most likely constitute an unapproved drug product. Are there even living cells in such products though?

Google search screenshot.

I’ve said this before, but while it’s bad enough to do any of this kind of thing, it really pisses me off when doctors and clinics inject children with unproven, potentially dangerous “stem cell” stuff that could be just about anything. In my opinion the goal at clinics injecting kids with unproven stem cells more generally often seems to be more about making profits than helping kids.

This new FTC development of money going back to families is good news, but if you read my original post on the FTC action in this case last year, it seems consumers paid far more on average than what they are getting back so that doesn’t quite add up. I’m not sure what the deal is here and how much the subjects of this FTC action paid to the agency in other costs. The original report mentioned $3.31 million, but it wasn’t clear about its status.

Just searching the web for Dr. Bryn Jarald Henderson found that what seems to be his office appears “permanently closed” (see image above), at least according to Google. I tried calling, but no luck.

In the big picture, how many other doctors (and suppliers) are selling perinatal materials as “stem cells” to treat just about any medical condition? We saw at least 12 people go to the hospital last year due to E.c0l1 and other bacteria in a perinatal product.

I hope we’ll see much more action here by federal and state regulators. People are getting hurt.

Sumber aciknadzirah.blogspot.com