Face & conquer the stream of negativity in our lives

Earlier this year, a blogger by the name of Paul Knoepfler, a professor at the University of California, Davis turned an unflattering, slanderous pen toward the LightWave Corporation with an apparent intention to build distrust among his readers. The crime?  LightWave dared research and develop a product that threatens the very business models of Establishment Medicine.

For over a decade, Mr. Knoepfler built an empire of followers around his reputation as a cellular biologist. He became a sort of guardian of the stem cell galaxy, protecting innocent and unsuspecting people from dubious players in the emerging stem cell domain of medicine. And for the most part, his work has been noble, well intentioned, keeping his readers informed.

Inspired by LightWave's recent commercial success, Mr. Knoepfler stumbled upon the subject content for his recent blog. The problem for Mr. Knoepfler of course to those aware of LifeWave's history of strong due diligence,  is that the holes in his blog would necessarily be sized appropriately for driving trucks through...it was a critical blog article written simply for the sake of writing his next critical blog.

And therein lies the backdrop.

Professor Paul Knoepfler's X39 critical blogsite can be found at https://ipscell.com/2023/02/lifewave-x39-stem-cell-patch-story-has-holes/

The blog is copied/pasted below for convenience, with replies and rebuttals to Professor Paul Knoepfler indicated in italicized text.

Just who is Professor Paul Knoepfler? And what is The Niche blog that includes Mr. Knoepfler's contributions?

From Science.org:

• Paul Knoepfler isn't a physician. And his University of California (UC), Davis, lab doesn't study arthritis or eye disease, nor does he have any experience developing a stem cell therapy. He mostly uses stem cells to study cancer-causing gene mutations. But thanks to The Niche, a blog he has run since 2010, Knoepfler has become an unlikely authority—and a dogged voice of caution—on the clinical use of stem cells.
• The blog, which now averages more than 4000 daily visits, has elevated him from an obscure bench scientist to an international spokesperson on all things stem cell. "It's one of the major sources of information [for the] layperson, and also for stem cell researchers," says Jeanne Loring of Scripps Research Institute in San Diego, California, an occasional commenter and guest writer on the blog.
• But even people who have expressed concern about predatory and fraudulent clinics contend Knoepfler has sometimes painted potential stem cell therapies with too broad a brush. "There are clinicians in the United States that are practicing forms of regenerative medicine that are legal and that are having good results for their patients," says Bernard Siegel, executive director of the nonprofit Regenerative Medicine Foundation in Wellington, Florida. "We can't tar everyone."
• Siegel says he admires Knoepfler, and his foundation honored the blogger with its national advocacy award in 2013. But in Siegel's view, Knoepfler has at times acted as "almost a bit of a societal scold."

Mr Knoepfler almost certainly started blogging with good intentions. Described as sort of "shy and diffident" sometimes, it is understandable just how self-empowering a blog site with more than 4000 daily visits can be. It is precisely this craving and desire for attention among shy people in particular that is at the root of this self-anointed guardian of the stem cell galaxy. It's a condition not unlike that of a young Instagrammer craving a massive following - manifesting as a psychological high to anyone suffering from Histrionic Personality Disorder.

In summary, cognitive dissonance and longstanding prejudices against regenerative orthobiologics, potentially coupled with a dependence on research grant funding from establishment medicine appears to now shackle Mr. Knoepfler as a prisoner - incapable of embracing fresh, novel ideas and approaches to stem cell applications.

The article itself wanders haphazardly from one irrelevant talking point to another, the author appearing hurried to completion during an evening of imbibing of the spirits.

I invite you to read on for the full assessment of Mr. Knoepfler's "Niche Blog" article critical of the very LifeWave products that customers worldwide praise with life-altering testimonials.

Regardless of whether or not you wish to try X39, or dispute the science behind it without trying for yourself, I truly wish everybody the best.

"LifeWave X39 stem cell patch story has holes

By Professor Paul Knoepfler, Ph.D. / February 14, 2023"

"I often learn about new supposedly stem cell-related products like the LifeWave X39 Patch from readers. Sometimes such products are used by tens of thousands of people, in my view potentially raising risks to the public."

"If nothing else, people might be spending their money on something that isn’t worth it."

From a pessimistic, cynical, can't-do perspective, this may be true. On the contrary, consider a positive and productive point of view: If nothing else, people might experience many life-altering improvements from something surprisingly affordable.

"As a stem cell biologist, how do I see LifeWave? What’s the claimed stem cell connection?"

As a mechanical engineer earning a living designing and managing the procurement of medical devices, I curiously await Mr. Knoepfler's findings. 

"The goal of today’s post is to fact-check the LifeWave X39 Patch. I also dig specifically into its stem cell activation claims."

Hopefully Mr. Knoepfler presents fair, unbiased, unprejudiced fact-checks, backed by solid assessment and sufficient research. It is an unfortunate reality that today's "fact-checking" sites do a notoriously poor job of remaining objective, as funding conflicts-of-interest often cloud and motivate a misrepresentation of the facts. 

"Overall, my claim review as a stem cell biologist is that in my opinion the X39 patch and its health claims do not appear to have solid science behind them.

It’s an unusual product with some surprising claims and backstory so the whole thing is very interesting even if highly problematic too in my view.

LifeWave X39 patch marketing image. From the firm’s website."

"The LifeWave X39 patch is a device about the size of a quarter that you stick on your skin. While as best as I can tell it does not actively emit new light itself like a bulb, it is claimed to expose the skin to only certain wavelengths of light, which I’m assuming have ambient light as the original source."

As is evidenced throughout this blog, its conclusions lean heavily on incomplete research and false assumptions. Here the author's lack of sufficient research sets the tone for the generally sloppy, imprecise nature of the paper's overall content. The most elementary product review would have revealed the body's own infrared energy as the light source, reflecting only a narrow bandwidth of this IR energy/light back through the body's skin.

"Here are the instructions: “Place one LifeWave X39™ patch on the body, use one of the locations shown below. Apply the patch to clean, dry skin in the morning. Patches may be worn for up to 12 hours before discarding. Keep well hydrated while using this product.”"

"I’m not sure, but it could be a medical device. The same might be the case for the X49 patch from the same company too."

Gasp! Oh no, not a MEDICAL DEVICE! Note that the alarming tone of this statement is derived primarily from a position of ignorance. The LifeWave patches are classified under the FDA umbrella of Low Risk General Wellness Products/Devices. So yes, in the most technical sense, these are disposable "medical devices". It is unclear why, but the author sounds troubled by this prolific device classification found over the counter just about everywhere. Read more about the FDA's oversight of General Wellness Devices at https://www.fda.gov/media/90652/download

"Why?

In part, it relates to the claims."

Note that each of Mr. Knoepfler's bulleted claims involve sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions, adhering to the FDA classification guidelines for General Wellness Products.

"They state that the X39 patches do several medical-related things via that light exposure:

• “Activate your stem cells!
• Patented phototherapy is designed to elevate a peptide known to enhance stem cell activity
• Supports relief of minor aches and pains.
• More energy and better sleep – must be experienced to be believed
• Supports natural wound healing process
• Maintains healthy inflammatory response”

Admittedly, I know less about FDA device rules than drug and biologics regulations, but it’s at least an important question to clarify."

Here the author at least recognizes and admits to an ignorance underlying his blog's misinformation campaign. Only marginally more FDA research would have secured this section with a  more stable footing.

"The LifeWave website instructs users to place the X39 patch on the skin of the back of the neck. How would one little patch placed there impact systemic things like the claims related to improved sleep and wound healing elsewhere?"

"As mentioned in the previous section, these patches are claimed to work by activating your stem cells.  How would that work exactly in terms of actual biology? It’s not at all clear."

As mentioned in the previous section, and evidenced throughout this blog, its conclusions lean heavily on incomplete research and false assumptions. Here the author's lack of sufficient research continues the tone for the imprecise nature of the paper's overall content. The most elementary product review would have revealed that the body's own infrared light reflects a narrow bandwidth of this IR back through the body's skin to elevate GHK-Cu Copper Peptide. The benefits of GHK-Cu are many, are well documented and searchable through Google, and are not considered controversial. Our bodies similarly process UV-bandwidth light from the sun to produce Vitamin D.

"I found 6 papers from a PubMed search for “LifeWave.” None of the papers provide concrete evidence to back up the claims about the patches in my view. I also found no clinical trial listings for a search for LifeWave and no relevant results for “X39” patches."

Is it not curious, convenient even, that the author limits his search for clinical trials to "Pub Med" only? With just a tad more curiosity and a smidgen less cynicism, unearthing the following few links would have led to the X39 clinical trials. Very few general wellness devices accompany greater due diligence than that offered by Lifewave's X39.  ¯\_(ツ)_/¯

https://ijhc.org/2020/04/20/lifewave-x39-pilot-demonstrates-light-triggered-changes/

https://ijhc.org/2020/04/20/changes-in-tripeptides-produced-by-thelifewave-x39-patch/

https://researchopenworld.com/double-blind-testing-of-the-lifewave-x39-patch-to-determine-ghk-cu-production-levels/

https://ijrsmhs.com/v6-i5(navigate to Phototherapy Induced Metabolism Change Produced by the LifeWave X39 Non-transdermal Patch)

"At this point in my research into these products, I found there was no strong reason to think the patches would activate stem cells or do so in a meaningful way to have systemic positive effects. A little patch also only exposes a correspondingly small area of skin. Could a little patch of skin exposed to light also make the skin release helpful endogenous substances throughout the whole body? I don’t believe there is good evidence of that either."

At this point in his research into these products, the effects from the author's hypothesized glass of red wine began to magnify longstanding prejudices against the regenerative orthobiologics industry at large. A failure to identify the supporting clinical studies or to ignore them altogether, his delight at discovering additional blog content, validating an ego with reader's comments, reminds one of a despairing Instagrammer perpetually seeking approval from her subscribers.

"I wanted to try to better understand at a molecular and cellular level what the firm was claiming the patches do to customers’ stem cells. After all, I am a cell and molecular biologist. I finally found a page with more detail on their site. It is focused in part on something called GHK-Cu. I’d never heard of it, so I looked up research on it."

After all of this blog's shortcomings, the author decides to rebuild credibility among his readers by reminding them that he is in fact a cell and molecular biologist. Fair enough. It is rather astonishing however, that such an acclaimed scientist would limit a search to only the Lifewave site, then finally find just one research article on the benefits of GHK-Cu. But then again, I am but a simple mechanical engineer lacking an ability to research the degree to which a university biologist is capable. Google has unfortunately made lazy researchers out of 21st Century academics. But just for grins, here are a myriad of GHK-Cu research articles that the good professor "overlooked:"

1) DeHaven, C. (2014). COPPER TRIPEPTIDE-1.

2) Pickart, L., Vasquez-Soltero, J. M., & Margolina, A. (2012). The human tripeptide GHK-Cu in prevention of oxidative stress and degenerative conditions of aging: implications for cognitive health. Oxidative medicine and cellular longevity, 2012.

3) Siméon, A., Monier, F., Emonard, H., Gillery, P., Hornebeck, W., Maquart, F. X., & Birembaut, P. (1999). Expression and activation of matrix metalloproteinases in wounds: modulation by the tripeptide–copper complex glycyl-L-histidyl-L-lysine-Cu2+. Journal of investigative dermatology, 112(6), 957-964.

4) Choi, H. R., Kang, Y. A., Ryoo, S. J., Shin, J. W., Na, J. I., Huh, C. H., & Park, K. C. (2012). Stem cell recovering effect of copper-free GHK in skin. Journal of Peptide Science, 18(11), 685-690.

5) Pickart, L. (2008). The human tri-peptide GHK and tissue remodeling. Journal of Biomaterials Science, Polymer Edition, 19(8), 969-988.

6) Pickart, L., Vasquez-Soltero, J. M., Pickart, F., & Majnarich, J. D. (2014). GHK, the human skin remodeling peptide, induces anti-cancer expression of numerous caspase, growth regulatory, and DNA repair genes. Journal of Analytical Oncology, 3(2), 79-87.

"A paper with first author Loren Pickart popped up. His affiliation is something called R&D Skin Biology or just Skin Biology in Bellevue, WA."

"Pickart and co-author Anna Margolina claim that GHK-Cu has regenerative and protective actions. The paper seems to be full of unproven claims rather than anything convincing to me data-wise. I found a few pubs by Pickart on PubMed. None of them seem at all convincing to me to support the sale of a small skin patch product claiming to improve health via stem cell activation by GHK-Cu. One paper claims an affiliation with the Research & Development Department of Skin Biology as though it’s a large corporation or university. I don’t see evidence of that either."

Here Mr. Knoepfler glosses over more than 60 research citations from the National Center for Biotechnology Information (NCBI) government website article in favor of targeting Pickart's affiliation for attack. Mr. Knoepfler's doctoral thesis could not possibly have survived scrutiny with such lackadaisical organizational standards. Has complacency overtaken curiosity in Mr. Knoepfler's present endeavors? Links to not one, but to two NCBI-archived GHK-Cu articles are repeated here for completeness:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6073405/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4508379/

"The proposed mechanism whereby light triggers increases in GHK-Cu and that in turn activates stem cells also brings to mind another product that I’ve fact-checked recently. The Augustinus Bader cream products also seem to claim to work by triggering endogenous stem cells via a substance called TCF8."

And here the author accidentally reveals that he DOES after all have clarity of the X39 activation mechanism that he previously claimed to "lack clarity" from the "Big Hole" section above. Further, what more surreptitious way to discredit a concept than to redirect the reader's attention and conflate X39 with an entirely unrelated activation mechanism?

"As another potential hole in the story and red flag, I don’t see that LifeWave leadership has rigorous stem cell research experience. What’s the leadership team?"

We can interpret "rigorous stem cell research experience," as "someone with MY expertise." The arrogance of asserting that only cellular and biology PhDs possess knowledge is reminiscent of politicians asserting that they know best how to run their constituents' lives.

Nevertheless, Mr. Knoepfler will be happy to know that Irish Government grants through the Science Foundation of Ireland (SFI) funded novel stem cell technology research at the National University of Ireland at Galway's Regenerative Medicine Institute (REMEDI) under Dr. Tim O'Brien's direction. While, true, not on the LifeWave leadership payroll, Dr. O'Brien and his team of research academics and cell biologists did play a pivotal role in developing X39.

"CEO David Schmidt is the inventor of the X39 patch."

It is unclear whether this fact troubles the author, but the fact is unsurprising given that CEO David Schmidt is the culmination of and is listed as the inventor on over 130 patents, most of which are biologically related. One does wonder how many patents and inventions that the author of this blog rightfully claims.

"On the page about Schmidt it says this: “One of his inventions, the Double Helix Conductor, produces a novel blend of electromagnetic and non-electromagnetic fields to improve the speed of wound healing that rivals that of stem-cell injections. This led to David realizing that phototherapy can be a means by which a person’s own stem cells can be activated into a more youthful state as opposed to requiring an injection of expensive and potentially dangerous stem cells . Hence, after ten years of study, the X39® patch was born.”"

It is unclear here whether Mr. Knoepfler is endorsing David Schmidt or if this is some novel approach to discredit David Schmidt. We can be pretty certain though that the author's limited curiosity of the CEO ended with this single bio. Because again, only PhDs in cellular/molecular biology can possibly possess the knowledge needed to invent any commercially viable product.

"Suzanne Somers promoting LifeWave in a YouTube video."

"What about Loren Pickart whose work LifeWave cites? I don’t see that Pickart works for LifeWave."

Would only a cynic identify and imply independent research as objectionable? Most objective observers would instead recognize unbiased, 3rd party validation as positive and desirable. A cynic would conversely pick apart a team that is unified at the hip by shaping the narrative that such a team is unreliably biased. See March 12, 2023 blog comment from user TERA J GWALDIS as a prime example.

"Pickart’s co-author on the GHK-Cu papers, Anna Margolina, has her email listed as the corresponding email on the paper. I emailed her about LifeWave and GHK-Cu but got no reply."

This is not surprising given that neither Pickart nor Margolina are affiliated with Lifewave and doubtfully respond to every random inquiry on the internet. That Mr. Knoepfler got no response from either is totally irrelevant to the validity of their combined research.

"Interestingly, the website that is the source of Margolina’s email shows her to be a hypnotist now. She also has a YouTube video on her site in which she uses a puppet to make some points."

Here the author resorts to a unique form of character assassination meant to discredit someone's research credentials - the assumption here is that because someone understands and practices hypnosis that they cannot also simultaneously chew gum. Repeating the theme, this is entirely irrelevant to the validity of published research and points to increasing desperation to strengthen what is turning into an increasingly weak blog argument.

"At this point in reading up on LifeWave, I was even less convinced there’s robust stem cell science behind these patches. The claimed light-induced GHK-Cu mechanism of stem cell activation seems dubious to me. I even went to the X39 patch patent document and still didn’t find convincing evidence that the patch does something beneficial to stem cells."

At this point in reading up on LifeWave, we reason that the author's empty glass of red wine succeeded to further magnify his longstanding prejudices against the regenerative orthobiologics industry at large. Having apparently no physical device inventions to his name, a basic understanding that patents serve to commercially protect a fundamental design concept or approach is lost on the author. Stem cell activation is outside the scope of this particular patent which instead focuses on the device makeup and construction and intended use. Patent development is both costly and time-consuming and represents just one element of protective due diligence of an idea. Continuing the chronic weakness undermining this blog, the content of the device patent document is largely irrelevant to the X39's activation mechanism.

"These are also expensive patches. Depending on the product, you can pay more than a hundred dollars for a month’s supply. If you use them for years, we’re talking about thousands of dollars."

This may not come as a surprise, but the author overstates the $99/month cost by nearly 3X, deliberately or not. But I digress.

In 2022, I personally opted for a bone marrow concentrate stem cell injection with my surgeon following major rotator cuff reattachment and repair. The "relatively" affordable one-time stem cell injection cost in excess of $5000 out of pocket, and the bone marrow harvest effected the single most intense pain that my body has ever experienced. Was the physical agony, the unknown efficacy, and the $5000+ worth it to add some confidence that the surgical site repaired to its strongest potential? Mr. Knoepfler might cast doubt, but one thing that is for certain is that X39 runs at a tiny fraction of the injection cost, is non-invasively pain-free, and theoretically, comes not with localized, but with systemic reactivity. With daily use, more than 5 years will pass before exceeding the injection cost. Now consider again, in context - with money back guaranteed, is $99/month really expensive??

"The prices seem even more unreasonable to me given that there’s no good evidence from clinical trials that these work."

The author was emotionally invested in his outcome before even starting, and has become even more so now that the conclusion draws nearer. I encourage Mr. Knoepfler to re-evaluate against the backdrop of overlooked clinical trials linked at the "Big Hole" section above. Again, considering the context of the regenerative orthobiologics medical domain as a whole - is $99/month really expensive??

"Perhaps part of the money earned goes to support the firm’s abundant marketing."

Perhaps marketing is ALWAYS funded from every company's profits. How else would marketing get funded? And more importantly, note theme repetition - what relevance does marketing have on the clinical studies supporting X39's efficacy? One of my continually repetitive life observations is that more often than not, a critic's criticism is a reflection, a projection some would say, of their own inner self. Which begs the consideration - perhaps the author's obedient conclusions throughout the vast majority of his blogs serve as a precursor, a prerequisite if you will, to salaciously desirable research grant dollars from establishment medicine?? Always, ALWAYS, follow the money.

"One of the LifeWave celebrity ambassadors is Suzanne Somers, who I assume gets paid for this role. Long-time readers of The Niche may recall that Somers has been a believer in alternative stem cell medical approaches for a very long time. She was apparently the first person who got a stem cell breast surgery. "

Yet again, here the author makes and relies upon assumptions as the foundation of his arguments. Neither what Suzanne Somers has done in the past nor what she gets paid, assumptions notwithstanding, have any relevance on the outcome of the published clinical trials which form the basis for LifeWave's X39.

"Does LifeWave have FDA approval for their device? Perhaps the firm argues they don’t need it."

This is another question that derives from ignorance, or basic misunderstanding of FDA oversight and can be forgiven. Actually the FDA argues, or rather defines, that FDA approval is not needed and has no context within the oversight of General Wellness Products. General Wellness Products by definition are 510(k) exempt.

Then what is the meaning of FDA Approved? This term is reserved for the highest risk “Pre market approval” or PMA devices. It is only this small subset of devices, subject to extraordinary scrutiny, which actually earn the label “FDA approved.” Interestingly, this is also perhaps the most abused term out there, yet Mr. Knoepfler would have you believe that LifeWave is somehow the deceptive one here.

Think about it. If the device never required a 510(k) clearance in the first place, the words “FDA cleared” or especially "FDA approved" are meaningless.

"I couldn’t find clear data on potential LifeWave patch side effects. Some folks on the web even claim that no side effects are possible, which is, of course, false. Anything that can activate one’s stem cells, assuming for one second that that claim is true, has the potential to do unhelpful things.  So there’s at least some possible risk here."

On a technicality, I suppose that a user could have an allergic reaction to the latex material or the adhesive. Otherwise, I respectfully refer the blog author to the FDA's risk guidance for General Wellness Products found at https://www.fda.gov/media/90652/download

IV. Determining Risk for General Wellness Products CDRH’s general wellness policy applies only to general wellness products that are low risk. If the answer to any of the following questions is YES, the product is not low risk and is not covered by this guidance.

1) Is the product invasive

2) Is the product implanted?

3) Does the product involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?

"My overall review is that the LifeWave X39 does not appear to have strong, published clinical science to support its claims based on a tiny patch. There could also be side effects. If the X39 is active in the skin itself, I would imagine at most it could positively impact locally nearby issues like tissue healing."

"Note that this patch approach is very different than drug patches, which contain concentrated chemicals. A drug patch releases a chemical into your body that then is distributed systemically via the bloodstream. The FDA says these transdermal drug patches are complex combinations of drugs and devices. LifeWave seems to instead rely on a supposed activation of one or more endogenous substances with cells already in your own body."

This is a true statement. X39 is non-transdermal, and is one of several reasons for classifying as a General Wellness Product.

"I also have some concerns about LifeWave as an MLM firm. Unfortunately, I was not able to find any other science-based reviews of these patches to cite."

Do note that the author states concerns, but fails to identify or elaborate exactly on these concerns. One's prejudices really have no place within the scientific method. Only results matter. The method by which a product is marketed and sold - be it through a health food store, online, door-to-door, or direct word of mouth marketing - again has zero relevance to the results of a product's clinical trials and general efficacy. We are fortunate, after all, to participate in a free-market economy.

"Overall, given the high cost and uncertainties, I would not recommend this product."

Given this author's grossly inadequate research, glaring study omissions, heavy reliance on diversionary and irrelevant statements, and broadly dismissing all life-altering user testimonials entirely as placebo effect, I advise taking this author's recommendation with the tiniest grain of salt imaginable. Some might even conclude ironically that Mr. Knoepfler has exacted a grave injustice onto the very people he purports to help, a tragic disgrace if so.

"Finally, note that the term “stem cell patch” has several different meanings today. There are LifeWave bandaid-like patches, but also other very different things.

There is rigorous clinical trial research ongoing for stem cell patches meaning either a layer of stem cells or a layer of differentiated cells made from stem cells. These stem cell patches are hoped to fix damaged tissue. They might repair holes or openings in tissues. For example, I’m very excited about spina bifida research ongoing right here at UC Davis Medical School (https://ipscell.com/2021/03/weekly-reads-stem-cells-for-spina-bifida-diabetes-trials-pubs/) involving stem cell patches. There are also studies of stem cell patches for other damaged tissues."

Well what have we here? The author green-lights orthobiologics research at his own research facility. Let that sink in for a minute.

"So keep in mind that “stem cell patch” is a broad term."

• Professor Paul Knoepfler's X39 critical blogsite

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