Treatment of sequelae of dementia and cerebral infarction paralysis

• (1) Pathway from the olfactory bulb through the cell stroma to the brain intervening part
• (2) Pathway from the trigeminal nerve to the brain stem and spinal cord
• (XNUMX) Capillaries in the mucous membrane allow cytokines to reach the brain in a shorter time and at higher concentrations than by oral administration or intravenous drip.

Currently, many medical institutions that perform self-pay treatment, especially medical institutions that provide cosmetic treatment, are administering stem cell culture supernatant liquid as part of their regenerative medicine business using multiple administration methods for various purposes. The growing interest in stem cell culture supernatant liquid has been linked to the aesthetic medicine business and regenerative medicine business, and many corporations selling stem cell culture supernatant liquid have sprung up in Japan. Stem cell culture supernatant liquid is expected to have many benefits for medical institutions that handle it, such as regenerative medicine that can be performed easily regardless of the Regenerative Medicine Safety Act, high profits expected, topicality, and short treatment times. A rapidly increasing number of medical institutions are introducing treatment using . At the 111th Japanese Society of Cosmetic Surgery held the other day, three presentations and special lectures were held and attracted attention. Despite the widespread use of stem cell culture supernatants, safety and ethical issues have emerged, and each manufacturer and seller has their own methods of procuring, manufacturing, storing, and selling cells that serve as raw materials for pharmaceutical preparations. Currently, medical institutions are not fully aware of the details and safety of the drug, and the name is the only thing that precedes it, and it is not clear whether it is effective or who is responsible if a problem occurs. Large-scale clinical trials such as double-blind studies have not been conducted, and there are no established standards for administration reagents, administration methods, doses, and subjects, and medical institutions' own administration methods or manufacturer-recommended administration methods are not recommended. This is currently being done by law. In other words, there is currently no evidence at all, and companies dealing with stem cell culture supernatant liquid are popping up like bamboo shoots, each promoting their superiority by presenting data using their own unique analytical methods. Domestically, mainly is sold as a stem cell culture supernatant, and there are various forms such as freeze-dried and cryopreserved. There has also been a problem in which stem cell culture supernatant fluid has been promoted because it has been confused with the recently talked about "exosomes." Not only is there no evidence of effectiveness, safety, or quality guaranteed, but there are also organizations that have even established their own incorporated associations to recommend the administration of stem cell culture supernatant fluids.

https://japan-saisei.org/about/
Companies that sell stem cell culture supernatant liquid are forced to give unreasonable discounts, or they buy cheap stem cell culture supernatant liquid that ignores quality and safety, and run flashy advertisements to increase treatment costs. There are also cosmetic surgery clinics that take and administer large doses.

Pharmaceutical safety, quality, and testing methods
There are many clinics that do this based on their own manuals, with no set standards and priority given to profit. Regarding stem cell culture supernatant liquid and exosome preparations, they are not drugs approved by the Ministry of Health, Labor and Welfare, but are reagents that doctors administer to patients under their own responsibility. For this reason, no clinical trials or large-scale clinical trials were conducted, and the manufacturer only analyzed the amount of his exosomes and cytokines using in vitro (test tube) data and presented it to medical institutions. Unfortunately, multiple deaths have occurred due to exosome infusion.

At this stage (October 29, 2023), the detailed cause and causal relationship with exosomes have not been reported, but it is a serious accident and should have been reported in the media, and should have been reported by the Accident Investigation Committee. It is considered necessary to establish a system immediately, conduct a thorough investigation of the cause of the fatal accident, take measures to prevent recurrence, and report to relevant organizations. I myself have received stem cell culture supernatant and exosome therapy, which have great potential, and intend to carefully incorporate them into my clinical practice, but I am trying to attract customers with exaggerated advertisements and advertisements at impossibly low prices. We are concerned about the existence and sales methods of cosmetic surgery clinics that administer reagents of low quality and whose safety is not guaranteed at all. If things continue as they are, various treatments using stem cell culture supernatants, which can be expected to be effective, may be subject to regulations from the Ministry of Health, Labor and Welfare, and their use may be restricted. We believe that risk management for the stem cell culture supernatant business can be carried out by accurately grasping and analyzing information on such stem cell culture supernatant fluids and carefully examining current issues and future directions. . Recently, in the beauty field, cosmetics companies are promoting stem cell cosmetics and cosmetics containing exosomes, and products introducing exosomes derived from human adipose stem cells from the Japan Stem Cell Cosmetic Evaluation Organization (PIA) have become more prominent, and the stem cell business is expanding beyond the medical field. It's busy. At our hospital, we only perform nasal therapy using stem cell culture supernatant, a reagent for which there is no evidence. Intravenous fluids are not administered due to lack of evidence.