Today I want to talk about exosome infusion therapy, which has become a hot topic in society.
Let me say this first.
I feel that treatments using exosomes/extracellular vesicles (EV) hold enormous promise and could become a new therapeutic option in the future, alongside drug therapy and cell therapy. That is precisely why I want to carry out careful basic and clinical research and deliver it to you safely.
However, exosome therapy has recently become a topic of conversation, mainly on social media, and a fair amount of incorrect information can be seen. I wrote this article hoping to reduce the chance that those of you receiving treatment will be disadvantaged.
I would like to describe what you should know about exosome therapy, divided mainly into three points.
First: Are exosome products really exosome products?
Second: Is exosome therapy really effective?
Third: What are the side effects of exosome therapy that you should know about?
Today I will focus on these three points.
So let’s begin.
Explanatory video
Are exosome products really exosome products?
Many people may not be aware of this, but the exosome products talked about in society are not genuine, pure exosomes. In many cases, what is called an exosome is a collection or concentration of particles roughly 30-150 nanometers in size, surrounded by a lipid bilayer, obtained from the culture medium after culturing stem cells. However, while this may contain exosomes, the majority may not be exosomes. Because various particles exist within the culture medium, extracting only exosomes is technically very difficult. Even in basic research, when handling exosomes, the question of whether these nanoparticles are truly exosomes arises.
For this reason, the International Society for Extracellular Vesicles (ISEV), the international research society for exosomes, decided in its guidelines to refer to the particles generally called exosomes in society as extracellular vesicles (EV). Furthermore, it was decided that an exosome refers to a vesicle that is released when a multivesicular body (MVB) — which exists as part of the endosome present within the cytoplasm — fuses with the cell membrane. Therefore, the exosome products currently used in clinics are, by global standards, extracellular vesicle products, and strictly speaking cannot be called exosome products. This point is also one of the causes of the difficulty with current exosome infusion therapy.
This is because the definition of exosome is ambiguous, which gives the impression that there are no established quality standards. It is unclear how many exosomes are contained depending on the product. How many products disclose this? Strict exosomes have something like landmark markers (CD63, CD9, CD81, etc.). In clinical practice, evaluations that guarantee quality — such as how many particles express these markers — are absolutely necessary. On this point, because established standards have not been settled even in the world of basic research, it becomes a very difficult problem. I also hear information that, depending on the product, the cell-supernatant culture medium is not concentrated at all, and the culture medium is simply infused as is. The culture supernatant may be contaminated with cell debris, chemicals, serum from other animals, and so on. Perhaps it would be reasonable to pay at least a little attention to how the product being used is manufactured.
Is exosome therapy really effective?
The next point I am concerned about is the lack of evidence demonstrating the efficacy of exosome (EV) infusion therapy. I recognize that this is a very difficult problem. Trying to scientifically prove effects such as fatigue recovery and anti-aging in clinical research takes time and generates various confounding factors, which make verification difficult. Also, it seems unlikely that public medical insurance would cover anti-aging or fatigue recovery. Therefore, if this treatment is performed for purposes such as skin beauty, anti-aging effects, and fatigue recovery, I think it is realistic to perform it under self-funded (free) medical care at one’s own responsibility. Personally, from my experience in basic research, I can infer that such effects can be expected from the EVs and exosomes of bone marrow mesenchymal stem cells. Therefore, if one verifies how much of an anti-aging effect can be confirmed at what dose by administering quality-controlled, identical exosomes to an animal model, and then applies that dose clinically, the reliability may be somewhat ensured. It might be worth checking whether animal experiments have been conducted with the exosome product you are about to be given, whether those results have been published in a medical paper, and whether those results have been scrutinized through the eyes of scientists.
At the clinical level, there is nothing that has scientifically proven the efficacy of exosome products. This does not mean they do not work; it means we still do not know whether they work. Please keep firmly in mind that the impressions of each individual person are biased, and that caution is necessary even when various influencers are spreading information. They may really be working, or they may not be working — the truth is, we still do not know. That is why researchers around the world, including me, are conducting research every day.
What are the side effects of exosome therapy that you should know about?
The last point to be careful about is the issue of side effects. As a mechanism of action of exosomes extracted from mesenchymal stem cells (MSC) (bone marrow stem cells, umbilical cord blood stem cells, adipose stem cells, etc.), one of the most frequently reported is an immunosuppressive effect. It is necessary to recognize that the immunosuppressive effect is a double-edged sword. Because chronic inflammation is considered a cause of aging, it may be possible to suppress progressive aging phenomena by regularly administering exosomes. In addition, even in life-threatening diseases such as myocardial infarction, stroke, and spinal cord injury (SCI), intense inflammation occurs at the lesion site, and this inflammation is said to cause secondary injury that further worsens the condition. Therefore, it is thought that administering exosomes regulates the inflammatory response, suppresses secondary injury, and promotes tissue regeneration.
However, the immune system also does very important work. By preventing the invasion of pathogens and defeating the cancer cells that arise daily, it maintains tissue homeostasis and allows us to live healthily. So what happens when exosomes are administered here? Various possibilities can be considered, such as the possibility of an increased risk of carcinogenesis, the possibility of contracting new infectious diseases, and the possibility of recurrence. Of course, an intravenous infusion may cause no problems at all. The current reality is that we still do not know. We can never say it is safe based on the results of administration to a few people. Aiming for extended healthy lifespan and anti-aging effects, you pay a lot of money for treatment, and as a result, cancer suddenly progresses, and in the end… I think it is necessary to recognize that you must have the resolve to undergo treatment having accepted that such an outcome is also possible.
I have told you various unpleasant things, but I believe that the future of exosome infusion therapy is bright. Anti-aging effects and extended healthy lifespan are what I aim for, so I would like to be able to provide such treatments. However, safety must be firmly ensured. To that end, I think it would be best if we could build an environment where research data can be accumulated and discussed. Furthermore, even in free medical care, by everyone collecting data and conducting post-marketing surveillance, we might be able to obtain some kind of insight. I hope things move in this direction. Personally, I want to make use of these exosomes in overcoming intractable diseases such as stroke and spinal cord injury. It is a very difficult road, but through clinical research and clinical trials, I will confirm efficacy and safety, go through regulatory approval, and work to deliver it to patients in need under health insurance. I believe that exosomes have enough potential to withstand this difficult road.
That is all.
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