As exosome work advances, clinics pitch unproven therapies to patients

exosome clinical trials
exosome clinical trials, map from Clinicaltrials.gov
Electron microscopy image of exosomes
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
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.

25 Comments

  1. What is American Association of Stem Cell Physicians? (http://www.aaoscp.com/) One of those things that seems like a legitimate medical conference, but seems short on credentials, and there is a class on ‘How to make stem cell eyedrops’ which scientifically seems absurd as any form of treatment. Of of Kimera Labs cites AASCP so…

  2. Your article is very insightful but aren’t most Stem Cell products being sold to patients or indirectly to doctors who intend to use to treat patients for ailments that are not covered by the applicable IND’ s that Stem Cell have been approved for? Also, don’t stem cells, especially when not autologlous, carry some inherent rejection?

  3. Paul you should interview people you mention in your blog to check if your opinion is correct and on this subject your wrong. Exosomes are proven to spinal cord injuries.

  4. Scientific data from trails in other countries plus I tagged you on Twitter and instagram on my video of new movement from exosomes. Look for yourself.

    • I believe something isn’t proven until it is concretely shown in a proper clinical trial. Selling an unproven product to patients seems wrong to me.
      I guess we’ll just have to agree to disagree.
      I wish you all the best, Chico, on your recovery.

      • Again it has be proven in proper clinical trials and my videos are concrete proof! I’m a 7yr Quadriplegic who had no sensation or movement below level and after the correct exosomes injection I have sensation plus starting to get movement. But instead of accepting new information you rather bash a doctor for helping the spinal cord injury community. Hope all followers read these comments and see how you ignore new information.

        • I don’t understand how Chico can claim to have no sensation or movement below his C4 level unless he forgot what happened to him 6 years prior:

          https://www.nola.com/health/2012/02/paralyzed_lsu_cheerleading_coa.html

          Jacie Scott reported in 2/12/12 that “…Some sensation has returned to his arms and legs…” since his injury on 8/27/11. By definition, he has incomplete tetraplegia. So any claim of recovery from exosome injection is subject to his recall of his function prior to injection – now contradicted by prior news items.

          A less subjective measure would be a thorough neurological exam conducted today and compared with his exams prior to 2018.

  5. Chico, you say “it has be proven in proper clinical trials” but in the databases, I found only 17 trials that have been completed of which none has reported any results – and most were only phase I safety studies. So which trials are you talking about with proof?

    Good to hear of your positive experience, but that´s no proof that exosomes work – your benefit could be due to many other things, including previous therapies. If your experience is really due to exosomes, then we should see this as a statistically significant benefit to at least 30% of patients in a trial with many patients, and not just one patient who is self-reporting.

    • In looking around, I also have seen zero conclusive evidence of efficacy or safety for this kind of experimental exosome “therapy” in humans. Preclinical data is interesting in some specific areas, but very preliminary. In my opinion given that context it is not right to sell it to patients. Also, every indication is that exosomes are drugs requiring pre-market approval from the FDA so its non-compliant to be selling it.

    • Over 800 trials have been documented, Dr. Neil Riordan wrote two books on MSC exosomes and benefits. He also references trails throughout the book and cases he has personally done in Panama. Exosomes are approved in several countries like Canada, Panama, Japan, China

      Juliuswippermann spinal cord injuries just don’t heal after seven years, it’s very obvious you are not familiar with this subject. I am not the only patient who is self promoting success with exosomes but I am one who found a negative article using my name.

      Joe rogan has a interview with Dr Neil Riordan and Mel Gibson on Exosomes and their success on YouTube. Feel free to watch and learn new information that contradicts your opinion Paul.

      • Hello Chico Garcia, I would be interested to read about these 800 trials with exosomes – can you tell me where I can find them? I´m not sure what you classify as a trial, but clinical trials approved by the respective national agencies, such as FDA or EMA, only number 100 worldwide. I checked the clinical trial databases in US, Europe, Japan and China and most are safety studies or cancer studies (for example, https://clinicaltrials.gov/ct2/results?cond=&term=exosomes&cntry=&state=&city=&dist=).

        I also checked the Panamanian clinical trial register and there has never been any approved clinical trials with exosomes in Panama.

        I am no expert on spinal cord injuries, but my background does include work on spinal cord regeneration in animal models, specifically in zebrafish. This is sufficient for me to conclude that severe spinal cord damage requires the activation and mobilization of oligodendocyte stem cells and the generation of new neuronal growth, which cannot be achieved in humans by exosomes. There is however, the possibility that exosomes could play a role early on after spinal cord damage to suppress the innate immune system from causing more damage along the same lines as MSC based immune suppression.

        You also say “Exosomes are approved in several countries like Canada, Panama, Japan, China” No they are not. Exosomes are not approved for therapeutic use anywhere in the world. I also couldn´t find any clinical trials, past of present, on exosomes involving Dr. Riordan or his affiliates.

  6. Hi,

    what exactly makes you think that exosomes should not be offered to patients yet? Which studies indicate a risk? Thinking about many chronic disorders with poor outcomes, I think it is a good idea that patients get access. If you look at the current treatments, which mainly involve aggressive immune suppression for the worst cases, I think exosomes almost can only do better…

    So, I, as a patient am happy it is available and I would do it if I can afford it. The drugs that I have to use really fuck me up….

    • @Karl,
      Thanks for your comment.
      In clinical science things work the opposite of your 2nd question. New drugs are not assumed safe and are not sold until someone proves they are risky. Instead, sponsors of a new drug product must first prove safety (and efficacy) in real, controlled clinical trials before selling it to patients.
      I think exosomes are an exciting technology overall, but that doesn’t mean they will necessarily actually work to help a specific medical condition like MS or be safe. Also, anything with the power to help will also have risks. For instance, if exosomes have immunosuppressive functions that are similar to toxic drugs like those you mention then exosomes will probably share some of the same risks.

      I’m totally supportive of doing clinical trials with specific exosome products if preclinical data are encouraging, but that’s a totally different thing than clinics selling unproven exosomes to patients for a variety of health conditions now, which in my opinion is unethical.

      To speed things up, if early clinical trial work on exosomes shows promise for a certain condition in humans, the sponsors, physicians, and patients also can work together to ask for expanded access (compassionate use) without waiting for years more work in later stage clinical trials. It’s a risk, but for some situations it may be worth trying it. Again, this is a totally different ball of wax than a clinic selling unproven exosomes for profit and giving patients false hope.
      Best wishes to you. Paul

  7. YES, PAUL…YOU STATE..”Instead, sponsors of a new drug product must first prove safety (and efficacy) in real, controlled clinical trials before selling it to patients. WELL WE KNOW THAT IS A CROCK OF SHIT… YOU CAN’T TURN THE TV ON FOR TWO MINUTES WITHOUT WATCHING COMMERCIALS ABOUT MEDICINE THAT WAS APPROVED WITH CLINICAL TRIALS AND APPROVED BY THE FDA …BIG PHARMA…AND NOW LAW SUITS ABOUND WITH DEATHS AND MAJOR HEALTH AND DAMAGING EFFECTS…THEY WERE ALL GREAT IN THE BEGINNING…AND ONCE THEY MADE THEIR BILLIONS, THEY DON’T GIVE A SHIT ABOUT HAVING TO PAY OUT A FEW MILLION TO APPEASE THOSE THAT HAVE BEEN SO BADLY DAMAGED BY THEIR WELL PROVED SAFETY DRUGS…BUT WHEN SOMEONE SUCH AS CHICO GETS GOOD RESULTS, HEAVEN FORBID THAT THERE ARE GOOD REPORTS OUT THERE ABOUT THAT PRODUCT (S)…BUT THEN AGAIN IF IT’S NOT IN THE POCKETS OF BIG PHARMA, IT’S NOT ANY GOOD…JUST SAYIN…. P.S. I’M NOT SHOUTING, I ALWAYS TYPE IN CAPS…

    • @JOE,
      I agree that there are a number of seriously flawed “approved” drugs out there and some unethical big pharma companies.

      However, on the stem cell front the lessons I take from this situation of problematic approved drugs are (1) the drug approval system isn’t perfect and even with clinical trial data, sometimes drugs get through that have problems, and (2) in this context, the totally unapproved stem cell products are even higher risk than the average approved drug. They haven’t been vetted at all.

  8. I think I’d rather take my chances with stem cells or exosomes because they have been around for years and I’ve heard many successful stories with little to no adverse reactions. As well as the increased interest to research them over the years from qualified scientists and doctors as opposed to taking an FDA approved drug that only masks the issue and may cause multiple other symptoms including kidney or liver damage long term. As time has told in real life as compared to clinical trials, the current drugs we take are not healthy nor safe. Regardless if they are fda approved. Thank God they put in place the ” Right to Try Act”

  9. State wastes $3 billion, asks for $5.5 billion more

    https://blog.independent.org/2019/09/03/3-billion-state-stem-cell-flop-now-wants-5-5-billion-more/

    This blog is all about “We failed at doing anything translational the last decade(s) via our ‘gold standard’ clinical route” so we don’t want anyone else to succeed with alternative approaches that are cheaper and have modest risk/benefit profile, because that would make us look…. more than losers

    To all you patients commenting – keep moving forward

    Don’t waste your time on this negativity

    • Not really. CIRM isn’t perfect, but it has 56 clinical trials ongoing. Not all of those will succeed, but I bet some of those are going to lead to proven safe and effective stem cell-related drugs that help people in need.

      Will CIRM get more funding? I don’t know, but even if not, there’s going to be some real positives from what it’s done so far for decades to come.

      As to patients commenting, this is a unique place where patients and skeptics can comment.

      As to some negativity (and reality), do you prefer mindless stem cell cheerleading?

  10. My nephew suffered a SCI 3 months ago (incomplete – grade B) and we’ve been researching stem cell/exosome therapy. The very last thing we want is to cause any more trauma to this young man. Anything new or promising since you’ve written this article? We’ve been referred to Dr. Spiel but I’m hesitant now after reading this article.

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