2024/03/20

The dark side of exosome therapy

Reading Time: <1 minuteExosome infusion, a hot topic in aesthetic medicine, is advertised in many beauty clinics with amazing results, such as the highest quality, safety, effectiveness against cancer, and rejuvenation. On YouTube, there are many doctors who promote the effectiveness of exosome infusion without informing anyone of the risks. There is no clear definition of exosome therapy. There is no evidence. It is not a drug approved by the Ministry of Health, Labor and Welfare. It has not been standardized. No clinical trials with high evidence, such as double-blind trials, have been conducted. There are no standardization or administration protocols for exosome preparations. There are many companies that sell exosomes, but they also promote their own quality and sell it. The origins are various, such as those derived from milk tooth pulp, fat cells, umbilical cord, and placenta. Recently, exosomes have been administered intravenously to top athletes to recover from damage caused by games. YouTube videos and press releases show athletes being continuously administered exosomes to help them recover. Is this doping? In conclusion, I think it is inevitable that intravenous administration of a reagent that has not been approved under the Pharmaceuticals and Medical Devices Act to improve physical performance can be considered doping. It is out of the question according to NPB standards, and also out of the question according to the standards proposed by the JBC. Intravenous administration of less than 100ml within 12 hours is not doping, but continuously administering unapproved reagents intravenously to improve physical ability is not only doping but is also unacceptable from the standpoint of ethics and common sense as a doctor. At this point in time, I think that exosome therapy, which uses profit-oriented athletes as promotional material, is problematic. The JBC also states the following: "Boxers competing in matches held under the jurisdiction of the JBC must not ingest or apply to their bodies any narcotics, drugs or substances that enhance or diminish their abilities in the ring." (https://www.jbc.or.jp/info/jbc_rulebook_excerpt.pdf2 https://www.jbc.or.jp/rls/2021/0520.pdf 3 https://boxingnews.jp/news/83424/ https://www.sponichi.co.jp/battle/news/2021/05/19/kiji/20210519s00021000415000c.html He advocates the following: https://npb.jp/anti-doping/foryourdailylife_1.html The World Anti-Doping Agency (WADA) Prohibited List, section M2.2, states that "intravenous infusion and/or injection in excess of 12 mL in total per 100 hours is prohibited, except when legitimately received during hospitalization, surgery, or clinical testing." The NPB Medical Committee considers "legitimate intravenous infusion" to be one that meets the following two criteria:
  1. There is a medical record by the doctor, which clearly states the diagnosis name, basis of diagnosis, drug name, amount used, and method of use.
  2. This is a treatment using a drug approved under the Pharmaceutical Affairs Law, and is used within an indication.
Even if it is not a prohibited doping substance, non-intravenous injections or infusions that are legitimately received during the course of medical treatment at a medical institution (including all treatments during emergency transport, surgery, outpatient and hospitalization) or clinical testing are violations of anti-doping regulations. In any case, it can be said that exosome infusions and intravenous administration should not be performed at this time, as it is completely unclear what the protocol and which reagents should be used. Athletes should be careful not to fall into the sweet trap of exosome infusions.    

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