Organization for the Promotion of Regenerative Medicine Safety [Regenerative medicine related services] Started providing new services using LINE
The Regenerative Medicine Safety Promotion Organization has launched the “Regenerative Medicine Consultation Office Official LINE”, a platform to disseminate the latest information on regenerative medicine and laws from a fair standpoint, and to respond to inquiries regarding patient problems.
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Currently, many clinics are providing treatments using exosomes and stem cell culture supernatants, which are not covered by the Regenerative Medicine Safety Act. Despite being unapproved
preparations, there appear to be many cases of violations of medical advertising guidelines, such as marketing them as regenerative medicine or touting their efficacy. Additionally, there have been many cases of intravenous administration of these unapproved preparations, which we believe is extremely dangerous from a safety standpoint. Our organization has established the “Regenerative Medicine Consultation Office Official LINE” as a consultation center for those who are troubled by troubles with medical institutions or after-effects after treatment received under regenerative medicine or similar notations. I did.
[About treatment using exosomes/stem cell culture supernatant fluid]
[Image 1: https://prtimes.jp/i/132628/4/resize/d132628-4-d18146cbe110a954d090-4.jpg&s3=132628-4-9760c372406cfd99dbad939c01f31c55-1023×1024.jpg]
[Image 2: https://prtimes.jp/i/132628/4/resize/d132628-4-1e117031e42a18cbf493-0.jpg&s3=132628-4-dd12786f8ee4ba7dc80365aeda3ad51e-1365×768.jpg] In April 2024, the Japan Society for Regenerative Medicine
(hereinafter referred to as “JSRM”) issued a statement entitled “Guidance on the clinical application of extracellular vesicles, etc.” It was announced that no country, including Japan, has given pharmaceutical marketing approval for treatments using cell culture supernatants, etc., and that guidance or guidelines have not been sufficiently developed. In December 2023, the Japanese Society for Extracellular Vesicles also announced the “Japan Society for Extracellular Vesicles’ Views on Medical Practices Using Extracellular Vesicles,” expressing the same concerns as JSRM. Furthermore, in October 2023, the Anti-Aging Association for Regenerative Medicine (hereinafter referred to as “AARM”) announced that a patient died from treatment using stem cell culture supernatant, an unapproved drug. We are announcing information that an event has occurred. According to this announcement, there are some clinics that are offering this treatment, touting its effects as “regenerative medicine treatment with rejuvenating effects,” and this is causing alarm. When AARM announced this information on its website, it became a hot topic on social media at the time, even though the word “stem cell culture supernatant” was unfamiliar to most people. In addition, most treatments called “stem cell culture supernatant fluid treatments” involve administering substances such as exosomes, which are contained in the supernatant fluid produced when stem cells are cultured, to the human body through a drip or nasal spray. The product is said to be expected to have benefits such as “rejuvenation”, “beauty”, and “improvement of body pain”. AARM also announced on its official website, “This is a therapy that has not yet been established as a medical standard, and we ask that you conduct a thorough examination based on evidence regarding its effectiveness and safety.”
[Image 3: https://prtimes.jp/i/132628/4/resize/d132628-4-ab7586a77f8d66f7b84b-3.jpg&s3=132628-4-df7efdb24d62d145171cdcad2fe95138-1364×768.jpg] Although the details of the deaths are unknown, some medical professionals have been sounding the alarm for some time, saying that the efficacy and safety of intravenous administration of stem cell supernatant fluid and exosomes have not been confirmed. Exosomes, which are substances secreted by cells, contain proteins and RNA, and have the role of transmitting information between cells, so research is underway to see if they could be used to treat diseases. . However, this is only at the research stage. Even researchers and cell cultivators have difficulty removing impurities, and it is also difficult to accurately measure how many exosomes are in a stem cell culture supernatant. The organization believes that it is necessary for doctors and patients to understand the current situation that stem cell supernatant liquid and exosomes are not bad in themselves, but that they are currently unapproved preparations, and to prevent problems from occurring. We hope that you will use the “Regenerative Medicine Consultation Office Official LINE” as a point of contact to accurately disseminate correct information from the large amount of information surrounding regenerative medicine and to receive consultations.
[Regenerative Medicine Safety Promotion Organization, General Incorporated Association]
Established in April 2023 with the aim of realizing a society where regenerative medicine is provided safely. We operate the “Regenerative Medicine Consultation Room” and “Regenerative Medicine Consultation Room Official LINE” so that patients, medical professionals, companies involved in the regenerative medicine business, etc. can access reliable information even if they are not experts in regenerative medicine. .
[Image 4: https://prtimes.jp/i/132628/4/resize/d132628-4-c04669f4917a24644e4a-2.jpg&s3=132628-4-c22334db5f07859c5b9be8ece6b364d3-3900×3776.jpg] Organization for the Promotion of Regenerative Medicine Safety Address: 5-1-12 Kashii Teruha, Higashi Ward, Fukuoka City, Fukuoka Prefecture 813-0017
Established: April 2023 Business content: Regenerative medicine related business URL: “Regenerative medicine consultation room” https://saisei-soudan.com/
[Image 5: https://prtimes.jp/i/132628/4/resize/d132628-4-229e098c9ab99952dcd2-1.png&s3=132628-4-322552afdb32807d1d90681fe686610a-540×540.png ]
“Regenerative Medicine Consultation Office Official LINE”
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More details about this release:
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