√ As Exosome Work Advances, Clinics Pitch Unproven Therapies To Patients

Electron microscopy image of exosomes, image labeled for reuse on the web.

Time to sell exosome therapies to patients? No.

Some stem cell clinics and related firms are looking for new ways to make profits and toward that goal a few have latched onto the legitimate buzz around exosome research.

What are exosomes?

Imagine if you could bubble up a pea-sized sphere off your skin full of good stuff without harming yourself and toss it over to your relative or friend like a mini-water balloon toss, whose skin would fuse with it and absorb the goodies in side, then becoming healthier.

Sounds like sci-fi at that imagined human scale, but cells do this kind of thing quite often. The cellular ‘water balloons’ are exosomes, tiny subcellular packages containing unique mixtures of various molecules including anything from RNA to proteins (check out this database of exosome contents, called ExoCarta).

Research shows that the cellular soup inside exosomes can influence cell behavior and there is a growing amount of legitimate work and excitement in this area. It’s not entirely clear that this cellular water balloon toss is always beneficial to other cells though.

A quick search on Clinicaltrials.gov found 95 study results, with the usual mix of relevant and not so relevant search results as well as more legit and less solid-looking listings, but overall this is a surprisingly large number of trials for this emerging area of biomedical research. You can see a map of trial locations below, with the U.S., Europe, and China leading the way.

Exosome clinical trials, map from Clinicaltrials.gov, August 23, 2018.

Just based on the state of the science, I believe that exosome research is not to the point where anyone should be directly marketing it to consumers (or indirectly to physicians) to try to make money, but people are doing this anyway lately and it seems centered on the supposed benefits of exosomes made specifically from stem cells.

One of the more recent examples of unproven stem cell exosomes apparently being sold comes from the story of a paralyzed former cheerleader and coach, Chico Garcia, looking for hope. Garcia is reportedly going to get “exosomes” from stem cells at a price tag of $11,000. The news story is short on details, but it mentions a physician:

“Dr. Douglas Spiel at the center said the way it works is they take very small products from young stem cells. Think of them as individual protein factories. They go to dormant cells in the body and inject the protein. The goal is for the proteins to help repair tissues in parts of the body that are not responding. “

A website for Stem Cell Center of NJ features Spiel and exosome therapies. For instance, there’s this passage.

“Dr. Spiel believes in ongoing self-education and study since the field of Regenerative Medicine is constantly evolving. He regularly attends, lectures and provides hands-on instruction for the Boston BioLife conferences multiple times per year. Besides having his own practice, Dr. Spiel is also Medical Director of Kimera Corporation, which is an international company providing Exosomes based out of Miami, Florida.”

On the NJ Center site it is claimed that exosomes might help various conditions including baldness, ED, spinal cord injury, neuropathy, and possibly stroke, although in the stroke section it is described (perhaps a typo) as “exome therapy” instead of “exosome therapy.” The exome is the collection of exon sequences in the genome. In my view the content on that page risks giving patients the wrong idea that exosomes are some kind of proven panacea.

“Kimera Corporation” mentioned in this quote is probably Kimera Stem Cell Labs/Kimera Labs, which seems to market some stem cells and exosomes. Dr. Spiel is listed on the Kimera site as its CMO.

There are others out there selling unproven exosome therapies as well and I expect the number is growing. I personally doubt the effectiveness of unproven stem cell exosomes as a therapy for many conditions.

Also, there will be risks. Sometimes exosomes from one cell that end up as part of another cell, may negatively influence the health of the other cell. Multiply that by billions or trillions and you can envision possible tissue damage in a hypothetical scenario of things gone wrong. My understanding is that exosome therapies are drugs, requiring an IND from the FDA and should go through clinical trials before being marketed to patients.

The bottom line is that in my view exosomes shouldn’t be sold to patients today even as I hope that in future years exosome therapies of some kind will be proven safe and effective from proper clinical trials.

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√ Several New Investigations Expose ‘Snake Oil’ Stem Cell Clinics

We need more investigations of for-profit stem cell clinics selling what some view as ‘snake oil.’ Over the years I’ve mainly resisted using terms like “snake oil,” but that phrase is being used more often and more recently I think we need to be blunt about what is being sold.

Part of effectively countering the worst of the clinics is for the media and others to do probing investigations. We need to shine some major sunlight on their practices, which then helps inform both patients and decisions by regulatory bodies like the FDA, FTC, state boards, and potentially even law enforcement.

It is hopeful to see several recent media pieces taking a healthy, critical look in this area.

Update: Here’s yet another investigative report, this one from CBS in Los Angeles, that just came out today on chiropractors (atTwins Chiropractic and Physical Medicine) selling unproven stem cells and also includes hidden video footage. Get this, reportedly the clinic pitch man Israel Matos who does the informercials is an actor who made obviously false statements during the seminar. What’s refreshing about this report though is that a 90-year old attendee of the seminar did her own research and exposed what was going on there. Check it out.

Over at Medium, science writer Karen Weintraub has a new piece rather bluntly titled, “‘Snake Oil’ Stem Cell Clinics Peddle False Hope for High Prices.” She in part focuses on patient Doris Tyler who lost her vision after going to a stem cell clinic in the US. Weintraub’s piece quotes stem cell scientist Sean Morrison, past President of the International Society for Stem Cell Research (ISSCR):

“Snake oil salesmen capitalize on the fact that people see reports on stem cells,” says Sean Morrison, a former president of the International Society for Stem Cell Research, adding that many clinics offer therapies that haven’t been proven to work and, biologically speaking, don’t even make sense. “Even many physicians are not sophisticated enough to understand that there are many kinds of stem cells.”

This other recent news story from News 5 in Cleveland, OH includes hidden camera video clips of over-the-top clinic claims at infomercial seminars. The investigation focused on chiropractors involved in clinics selling unproven “stem cell” offerings to vulnerable patients. These may not even really be stem cells at all, but it’s hard to say. You can see my recent piece here calling on chiropractors and their state oversight boards to stop the exploding area of chiropractic office stem cell injections.

Most often the patients these days targeted by clinics are senior citizens. Remarkably, News 5 reported that the head of the Ohio chiropractic board, Greg Palkowski, himself appears to run or be involved a stem cell clinic. That clinic’s regenerative medicine page even quotes FDA Commissioner Scott Gottlieb, which seems to me to be an unwise move, but one we’ve seen in the past from other clinics including in one case in a big newspaper ad.

A Chicago news team also did an investigation that they recently reported. There are some common themes in these investigations. The Chicago one also includes a chiropractor angle discussing statements a reported clinic owner and chiropractor, Dr. Jill Howe. They quote Howe from a promotional video:

“It’s injected into the area that’s injured,” she said, and then will go in and “regenerate tissue that you’re missing so you can get new cartilage, you can get new knees, you can get new shoulders, new nerves.”

That sounds like hype in my opinion and I don’t believe there is good science to back up those claims. This kind of skepticism is the consensus in the stem cell research field. The Chicago news piece also quotes Sean Morrison:

“One of the things that we see among people selling fake stem cell therapies is they jump in early without testing whether something is safe and effective and start selling it to desperate patients,” Morrison said. “Our belief at the International Society for Stem Cell Research is that there are many companies operating in the United States that are selling fake stem cell therapies that are not legal under FDA regulations.”

More investigations by news teams are ongoing and will shed additional light on the worst clinics, which again I think can rightly be called snake oil clinics. Along with the bad press as lawsuits and documented patient harms accumulate, you’d think at some point a potential Achilles heel for the worst clinics and their providers would be inability to get malpractice insurance.

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√ Red Flag For Joint Commission For Its Gold Seal Approval To Former Stem Cell Clinic Firm

The Joint Commission apparently has given some kind of seal of approval to the unproven stem cell clinic-related firm, the Lung Institute, or as it is now often called the Lung Health Institute. For me this raises concerns about the Joint Commission itself or at least its ambulatory care accreditation kegiatan through which Lung Health got its thumbs up.

What’s the back story here?

The Joint Commission is a respected U.S. entity that reviews standards at a variety of thousands of health care organizations including big hospitals. If you’ve been to a big hospital there’s a good chance they were accredited by the Joint Commission. However, the Commission apparently gives accreditation to smaller clinics of various kinds too.

When I saw the Joint Commission gold seal of approval on The Lung Health Institute website, I was concerned and puzzled. Frankly, I saw it as a red flag for the Joint Commission since my opinion of The Lung Institute isn’t very positive.

Why?

I’ve been following them on this blog for years. Up until just months ago it seemed like the Lung Institute was a stem cell clinic marketing some kind of non-FDA approved “stem cells” for respiratory problems, which didn’t make a lot of sense at least to me as a stem cell biologist. Now I’m not clear if they use stem cells any more at their clinics based on the text on their websites. They seem to be using some kind of IV of a PRP-containing cellular medicine substance to try to treat lungs and other respiratory tissues. This also doesn’t make much sense to me.

As I’ve written before there also has been a proposed patient class action lawsuit pending against the Lung Institute. Was the Joint Commission aware of this? A Commission official doing an audit could have easily found information on the lawsuit and other concerns on the web. For instance, a brief search I did just now found this concerning news article from last year. I’m not sure of the current status of the lawsuit.

Screenshot from Lung Health Institute website mentioning approval from the Joint Commission. Did the Joint Commission carefully examine safety and quality of care? Even do a simple web search?

Beyond the seal of approval for Lung Health, the Joint Commission seems to positively gush with praise in the press release (PR):

“Joint Commission accreditation provides ambulatory care organizations with the processes that contribute to improvements in a variety of areas from the enhancement of staff education to the demonstration of leading practices within the ambulatory setting,” said Michael Kulczycki, M.B.A., CAE, executive director, Ambulatory Health Care Accreditation Program, The Joint Commission. “We commend the Lung Institute and its staff for achieving this pinnacle, demonstrating a commitment to patient safety and quality. Your passion, dedication and tenacity can ultimately improve patient care. Thank you for your commitment to patient safety and entrusting The Joint Commission to assist you.”

Pinnacle? Passion? Dedication? Tenacity?

My anabawang high English teacher Mrs. Smith would have dinged me for such flowery writing. To me it seems almost like words from an infomercial on TV rather than a statement from a respected, sober clinical compliance organization like the Joint Commission.

Out of curiosity, I searched the web for “Your passion, dedication and tenacity can ultimately improve patient care” and found hundreds of mentions of that exact phrase related to the Joint Commission’s Ambulatory Health Care Accreditation Program. They even provide a MS Word template (note that if you click on that link it will automatically d0wnl0ad the template so if you don’t want it, don’t click) with this exact verbiage for use by clients.

Is that a good idea?

How does an organization get this ambulatory care accreditation and the right to use the glowing press release? In part you pay a large fee as the Joint Commission charges for accreditations. From their FAQ page:

“Q: What’s the cost?

A: Accreditation fees include an on-site survey fee and annual fee, both based upon your “average daily census” and services provided.

The average accreditation annual fee for an organization serving approximately 100 patients or residents each day is $2300. The average on-site survey fee for a nursing home of the same volume is $3315 (this is due in the year of the on-site survey).”

The money could really add up. How many Commission clients are there just in the ambulatory care area? The Lung Health PR mentioned a remarkable 8,500 accredited sites of just ambulatory care (assuming I read it right) so if that’s accurate, that could add up to nearly $20 million in annual fees just in this one narrow area for The Joint Commission.

I emailed the Joint Commission to ask both about the Lung Health Institute seal of approval and the Joint Commission promoting such a gushy press release for hundreds of firms. Their reply didn’t really address my concerns about their over-the-top publicity verbiage, but they did clarify that the “accreditation” of this kind from them has an extremely narrow definition:

“The Joint Commission does not assess or address specific clinical methods or clinical treatment. As such, per our guidelines to health care organizations when they receive accreditation and permission to refer to their accreditation and the Gold Seal: Accreditation does not endorse a kegiatan or organization’s quality of care. Nor does it “prove,” “assure” or “testify” that a kegiatan or organization provides quality care.”

There’s not even an endorsement of quality of care? In my opinion this seems to conflict with both the gushy PR statements related to the Commission accreditation and with the interpretation of the accreditation on The Lung Health Institute website (see screenshot above).

In my brief searching around the web I also found another concerning issue with the Joint Commission. According to a recent piece in Modern Healthcare the Joint Commission is being probed by the Center for Medicare and Medicaid Services (CMS), a federal agency:

“The CMS has faced pressure to address the concerns that the Joint Commission and other accrediting agencies engage in conflicts of interest by acting as both an enforcer of Medicare rules for hospital participation while taking on hospitals as clients to improve their performance.”

A recent article in The WSJ in addition suggested The Joint Commission has continued to collect fees and not pull accreditation from seriously problematic client institutions.

I’m sure the Joint Commission does a huge amount of good overall, but the ambulatory care “gold seal” approval to this one former stem cell clinic suggests a bigger duduk kasus to me with how the Commission approves firms via this ambulatory care program. In my view this isn’t likely to be in the best interest of patients.

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