"Exosomes" have recently become popular in the cosmetic medicine industry. Treatments that use this substance released from cells are sometimes considered "regenerative medicine," and celebrities and famous businessmen have been promoting it. However, behind the hype of "a new era of cosmetic medicine," there is a big pitfall. [See photos] The rapid increase in regenerative medicine clinics in Ginza and elsewhere ***
Ginza and Nihonbashi in Tokyo are high-end shopping districts that represent Japan. Clinics advertising regenerative medicine have been increasing in number in these areas in recent years. The Ministry of Health, Labor and Welfare issued an emergency order to one such clinic in October last year, suspending the provision of regenerative medicine. A reporter from a national newspaper said, "The clinic that received the emergency order was a clinic that provides regenerative medicine, which claims to prevent cancer, as an optional treatment. The clinic provided a treatment in which immune cells called NK cells were taken from the patient's body, cultured and processed, and then returned to the body to activate the patient's immune system, but two of the patients who received the treatment ended up with a serious infection." This treatment is extremely expensive, costing around 10 million yen per course. The selling point was that the safety was guaranteed because the cells were cultured in a "clean room" in a dedicated facility. "However, the processed cells cultured there were contaminated with bacteria, so in the end it must have been poor management. The medical corporation that operated the clinic promptly closed the clinic, but another affiliated clinic continues to operate as if nothing had happened." (ibid.)
A never-ending stream of medical accidents
When you hear the term "regenerative medicine," many people will surely conjure up images of "advanced medical care" or "cutting-edge medical care." Some may recall the "iPS cells" of Shinya Yamanaka, winner of the Nobel Prize in Physiology or Medicine in 2012, or may conjure up the dream story of "immortality and longevity." However, when asked "Is it safe?", most people probably have no idea. In fact, in recent years, there has been a never-ending stream of troubles and medical accidents surrounding regenerative medicine. It seems that regenerative medicine, which has been overemphasized in its "infinite possibilities" and has neglected its safety, is becoming rampant. What on earth is happening in the field of regenerative medicine?
"It's like regenerative medicine"
In the world of regenerative medicine, which is a mixture of good and bad, the term "regenerative medicine" itself is vague and unclear, points out Nobuyuki Kazuki, representative director of the Regenerative Medicine Safety Promotion Organization. "As you may imagine, regenerative medicine is a treatment that "regenerates" cells, tissues, and organs damaged by disease or injury back to normal. However, there are two types of regenerative medicine that are generally provided today: regenerative medicine provided within the law, and "quasi-regenerative medicine" provided outside the law." (Kazuki) The "law" here refers to the Act on Ensuring the Safety of Regenerative Medicine, etc. (Act on Ensuring the Safety of Regenerative Medicine, etc.), which was enacted in 13 and came into effect the following year. In regenerative medicine, in many cases, cells are taken from the patient's body, cultured and processed, and then returned to the patient's body for treatment. The Act on Ensuring the Safety of Regenerative Medicine stipulates strict processes that must be followed when performing such regenerative medicine. "Specifically, when providing regenerative medicine, medical institutions are required to create a 'Regenerative Medicine Provision Plan' for each treatment method for each disease. Then, these provision plans are submitted to the 'Specific Certified Regenerative Medicine Committee', which has been certified by the Ministry of Health, Labor and Welfare based on the Safety and Security Act. After approval, clinics can only provide regenerative medicine after submitting a notification to the Minister of Health, Labor and Welfare." (ibid.)
The law is "watered down"
However, even if the Safety Assurance Act sets out strict rules, if the clinic does not actually follow them, the safety will naturally end up being nothing more than a pipe dream. The clinic introduced at the beginning is a prime example of this problem. According to the national newspaper reporter mentioned above, "The clinic that received the emergency order in October also created a provision plan based on the Safety Assurance Act and obtained the committee's approval. Furthermore, the medical corporation that runs this clinic apparently entrusted the operation of its own cultivation center to a bio-company listed on the Tokyo Stock Exchange Growth Market. However, an on-site inspection by the Ministry of Health, Labor and Welfare after the emergency order confirmed multiple violations of the law, including provision in a way that differed from the plan, leading to the issuance of an improvement order. It is by no means possible to say that "it is safe just because the committee has approved it." In other words, the Safety Assurance Act has been effectively gutted, and it is almost impossible for ordinary patients to tell which regenerative medicine is truly safe.
Selling nonstop with a focus on profit
Even regenerative medicine provided within the law has questionable safety, so you can imagine how unsafe "as if regenerative medicine" provided outside the law is... However, in the current regenerative medicine industry, this "as if regenerative medicine" is extremely popular. Kazuki sighs. "The most representative of this type of 'regenerative medicine' is a treatment called exosome therapy or stem cell culture supernatant therapy. These do not use cultured stem cells directly, but rather extract the supernatant fluid remaining after culture, or a substance called exosomes secreted by the cells, and apply it to the skin or inject it into the muscle to achieve a therapeutic effect. Since the cells are not injected into the body, it is outside the jurisdiction of the Safety and Security Act, and there is no need to create a troublesome donation plan or apply for deliberation at a committee. Since it uses the so-called 'waste' after culturing cells, the price is only a few tens of thousands of yen, which is incomparably cheaper than regenerative medicine provided within the law. Moreover, it is popular because it is 'easy', so doctors who do not understand the effects or risks are selling it with 'profit first' in mind."
There is also a risk of risk to life
In fact, when searching for supernatant fluid and exosomes on the Internet, you will find many claims of dreamlike effects such as anti-aging, repairing damaged tissue, hair growth, fatigue recovery, and immune regulation. Some of these claims even claim to be cutting-edge medical treatments, such as "using iPS cells." However, in reality, there are many inferior products on the market that are far from being "dreamlike treatments," and it cannot be denied that they may even put your life at risk. "One of the risks of 'regenerative medicine' is that you don't know who's cells are the raw material for the product. In regenerative medicine within the scope of the law, basically, the cells used are one's own cells. However, according to our research, of the approximately 700 medical facilities currently offering supernatant fluid therapy or exosome therapy in Japan, very few facilities clearly announce that they use the patient's own cells. In fact, more than 8% are derived from other people's cells, or worse, they may not even be derived from human cells. In addition, expert research has revealed malicious cases in which a 'mysterious liquid' that claims to be exosomes but does not contain any exosomes at all is used, so caution is required."
"Suicidal"
Smearing a mysterious liquid of unknown origin onto the skin - the very thought of it is terrifying, but what's even more dangerous is the fact that there is a treatment option in which the liquid is injected intravenously. By "intravenous injection", the active ingredients in the supernatant and exosomes circulate throughout the body more effectively, and are more effective against a variety of diseases. That's the selling point, but experts say it's nothing less than a "suicidal act" that could end in death at any time. In fact, the Regenerative Medicine Consultation Room of the Japan Regenerative Medicine Safety Promotion Organization receives desperate "cries" every day. Kazuki says: "A man who had erectile dysfunction due to psychotropic drugs received a local injection of exosomes into his penis at a clinic. A few days later, he began to experience severe pain and numbness in his limbs, making it difficult for him to even sit up. When he sought medical advice at a clinic, he was turned away, with the explanation that it was a 'mental problem.' Another man was recommended an exosome infusion by a hospital to treat a cerebral infarction. He paid a total of 10 million yen for 400 infusion treatments, but by the time the ninth infusion had finished, there was no effect at all. When he asked the doctor for an explanation, he was simply evaded."
Decreased level of consciousness and emergency transport
A doctor who runs a regenerative medicine clinic in Tokyo also testifies: "Applying supernatant fluid or exosomes to the skin as a beauty serum poses almost no risk in terms of health damage, and in fact has been shown to have some beneficial aspects. However, this is only possible if the serum does not penetrate deeper than the dermis. If there are impurities in the supernatant fluid or exosomes, injecting them into a vein will cause the impurities to circulate throughout the body and, in the worst case scenario, can even be fatal. A doctor I know was suggested by a company to offer intravenous exosome injections as a treatment at his hospital, and when he tried injecting them into the veins of his own arm, his consciousness immediately dropped. He ended up having to be rushed to the hospital." Nevertheless, he says that the reason why the dangerous practice of "intravenous injection" is so prevalent is solely due to doctors' ignorance, and "Among the doctors who offer what appears to be regenerative medicine, there are quite a few who are not specialists in regenerative medicine. The reason they are using supernatant fluid and exosomes is simply because they have been persuaded by unscrupulous cell dealers who tell them that it will be profitable. Anyone can produce supernatant fluid and exosomes as long as they have the necessary machinery, and no qualifications are required, so recently many businessmen have been getting into the cell culture business with a "venture mentality." These fledgling businesses are approaching doctors who are not specialists by asking, "Would you like to work with exosomes?" (ibid.) Until now, the world of regenerative medicine has only focused on its positive aspects. It would be great if research could advance and eliminate "incurable diseases," but it should be remembered that there are still many pitfalls lurking behind the claims of "immortality and longevity." Article published in the January 2025, 1 issue of "Weekly Shincho"
