Treatment of sequelae of dementia and cerebral infarction paralysis

Currently, stem cell culture supernatant is administered in many medical institutions that perform self-paid treatments, especially in medical institutions that perform cosmetic treatments, and is administered in multiple ways for various purposes as a regenerative medicine business. The growing interest in stem cell culture supernatant has led to a proliferation of corporations selling stem cell culture supernatant in Japan, as it is linked to the cosmetic medicine business and the regenerative medicine business. There are many benefits for medical institutions that handle regenerative medicine, such as easy regenerative medicine that is unrelated to the Regenerative Medicine Safety Ensuring Act, high profits, popularity, and the ability to treat in a short time, and the number of medical institutions that introduce treatment using stem cell culture supernatant is rapidly increasing. At the 111th Japanese Society of Aesthetic Plastic Surgery held the other day, three special lectures were given and attracted attention. Despite the popularity of stem cell culture supernatant, safety and ethical issues have also emerged, and the current situation is that each manufacturer and seller is independently implementing the methods of procurement, manufacturing, storage, and sales of the cells that are the raw materials for the preparation. Medical institutions are not familiar with the details or safety of the product, and only the name is mentioned, and it is not clear who is responsible when effects or problems occur. No large-scale clinical trials such as double-blind studies have been conducted, and there are no established standards for the administration reagents, administration methods, dosages, or subjects. Instead, each medical institution administers the product in its own way or according to the administration method recommended by the manufacturer. In other words, there is currently no evidence whatsoever, and companies dealing in stem cell culture supernatant have proliferated like bamboo shoots, each promoting its advantages by presenting data using their own analytical methods. In Japan, the main 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), no detailed cause or causal relationship with exosomes has been reported, but it is a serious accident and should have been reported in the media. Ideally, an accident investigation committee should be immediately established to thoroughly investigate the cause of the fatal accident and prevent recurrence, and report to relevant institutions. I intend to carefully incorporate stem cell culture supernatant and exosome therapy, which have great potential, into my clinical practice, but I am concerned about the existence and sales methods of cosmetic surgery clinics that attract customers with exaggerated advertising and unbelievably low prices, and administer reagents that are of low quality and have no guarantee of safety. If things continue as they are, various treatments using stem cell culture supernatant, which is expected to be effective, may be subject to regulations from the Ministry of Health, Labor and Welfare, and their use may be restricted. By accurately understanding and analyzing such information about stem cell culture supernatant and thoroughly examining current issues and future directions, I believe that risk management for the stem cell culture supernatant business can be implemented. Recently, in the beauty field, cosmetics companies have been promoting products called stem cell cosmetics or cosmetics containing exosomes, and products using exosomes derived from human adipose stem cells (PIA) by the Japan Stem Cell Cosmetics Evaluation Organization (JSCCA) have become prominent, and the stem cell business is booming outside of the medical field. At our clinic, we only perform nasal instillation therapy using stem cell culture supernatant, a reagent with no evidence. Intravenous fluids are not administered due to lack of evidence.