Category Archives: Regenerative Medicine

South Korea: New Regenerative Medicine Laws in 2025

South Korea’s aging and record low birth rate society is necessitating rapid changes to government regulations when it comes to the regenerative medicine sector. Speed is the name of the game, and South Korea’s large hair loss research sector will likely benefit as a result.

Regenerative Medicine South Korea
New Regenerative Medicine Regulations in South Korea.

May 29, 2024

South Korea Advanced Regenerative Medicine and Biopharmaceuticals Act: February 2025

On May 27, 2024 it was announced that South Korea’s Ministry of Health and Welfare will release a draft enforcement ordinance for the “Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act” in the next month. This revision to the “Cheomsaeng Act” (passed in 2020) is scheduled to go into full effect from February 2025.

The revised laws will revitalize regenerative medicine and biopharmaceutical research in South Korea, and speed up the development of cell and gene therapy (CGT) treatments. Moreover, South Koreans will be allowed to receive advanced regenerative medical treatments (including stem cells) in South Korea. Reducing the current trend of going abroad to Japan and other developed nations.

According to a May 14, 2024 article in Korea Biomedical Review, local biopharmaceutical companies have high expectations from the amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals. This regulation passed the National Assembly in February, 2024 (see below).

February 2, 2024

Amendment to Regenerative Medicine Safety Act

In February 2024, South Korea passed a bill that adds regenerative medicine organizations to the list of those considered for human cell management business licenses. This will have positive implications when it comes to faster in-clinic use of new autologous hair loss treatments.

According to one article, this amendment to the Advanced Regenerative Biotech Act will serve as a positive catalyst for both South Korean and Japanese cell therapy companies. Note that Japan fast tracked its stem cell regenerative medicine rules a decade ago. Both South Korea and Japan suffer from rapidly aging societies with extremely low birth rates. Thus making regenerative medicine a topmost government priority.

The title of the bill that South Korea’s National Assembly passed is:

“Amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals.”

This amendment will add regenerative medicine organizations to those considered for licensure to manage human cells. The cell management business entails the collection, importation, testing, and processing of human cells. These organizations supply cells as raw materials for advanced biopharmaceuticals.

In addition to existing manufacturers and umbilical cord blood banks, advanced regenerative medical institutions will now be recognized as licensees for managing human cells.

If the revised advanced regenerative biotech law is enforced (as expected):

“Advanced regenerative medical institutions with facilities, equipment, and manpower similar to the standards for licensing human cells and other management businesses will be recognized as licensed as a management business.”

Subsequently, advanced regenerative medical institutions will be allowed to supply raw materials to advanced biopharmaceuticals through simple separation, washing, freezing, and thawing of cells derived from patients.

Of special significance, this opens the way for actual patients (rather than just research subjects) to receive regenerative medicine services. Even if a South Korean patient is not a participant in a clinical trial, he or she can in the near future still receive cell therapy treatment.

I hope that these law changes will benefit the increasing number of new South Korean stem cell based hair loss treatment companies.

RIKEN Fundraising for Regenerative Medicine

RIKEN is a Japanese government funded research institute, with one of their many areas of focus being hair loss cure research. They get very little in the way of public donations. This should change in FY 2021 due to their widely publicized request (which I discuss in the second half of this post).

RIKEN Updates

Update: October 12, 2021

Two interesting new developments this week in relation to RIKEN and hair made me update this post.

  • First, they published some interesting new findings in relation to untangling the process of hair follicle development. Their scientists created a dynamic four-dimensional atlas that explains the origins and development of adult hair follicle stem cells. They call this a telescopic model and it analyzes the cellular dynamics and gene expression changes involved in hair follicle development. The actual study was published in “Nature” in June 2021 and is titled: “Tracing the origin of hair follicle stem cells.” Per lead researchers Hironobu Fujiwara and Ritsuko Morita:

“The findings could help drug developers to design new therapeutics to combat baldness and other types of hair loss.”

  • Of more interest to this blog’s readers, a new lengthy summary of RIKEN and Dr. Takashi Tsuji’s work was just published in an online Chinese publication. There seems to be some kind of collaboration between RIKEN and ISEI Health in China’s regenerative medicine sector. Thanks to “Jan” for first posting the link. Key quotes from Dr. Tsuji below, including an implication that trials already started:

“The initial hair follicle regeneration clinical trial invested about 500 million yen. If the results are confirmed, I want to spend an additional 1 billion to 1.5 billion yen to gradually increase the number of trials.

“Cost is about 50 million yen until the first 100 people. If it becomes 10,000, it will be reduced to 25 million yen, and after that, it will be reduced to 15 million yen. The more users there are, the more likely the cost is. reduce.”

February 11, 2021

I have never written a fundraising related post on this blog before. I have encouraged readers to donate small amounts in order to send people to major hair loss conferences twice. However, those fundraising goals amounted to just several thousand USD.

Several days ago, we learnt that Dr. Takashi Tsuji and his hair loss cure project was still progressing. Although he split from commercial partner Organ Technologies in 2020, his RIKEN (Rikagaku Kenkyūjo) team’s research continues to thrive. Next stop is clinical hair regeneration.

RIKEN Fundraising

However, the hair loss and teeth regeneration work from RIKEN now needs private funding.

“The team is seeking 500 million yen ($4.8 million) in donations from companies and individuals. The money will be used not only for clinical testing on the safety of the hair transplant technology, but also for other trials, such as regenerating teeth.”

  • In FY 2018, RIKEN received only 37 donations for a total of approximately 8 million yen. Equivalent to $76,000 at current exchange rates.
  • In FY 2019, RIKEN received 380 donations for a total of 25 million yen. Equivalent to just $240,000 at current exchange rates.

I wrote to the RIKEN team and suggested their using GoFundMe or contacting Allergan for investment. The latter has invested in 5 hair loss companies in recent years. In 2019, Allergan gave $25 million to Exicure, along with potential milestone payments of $265 million. RIKEN only needs $4.8 million.

Surprisingly, RIKEN replied to me right away. They were interested in my introducing them to the Allergan team, so I will need to figure that one out! More importantly, they said that they have created the below two links for those who want to donate:

Update: I have asked them to add a Paypal option. Hope they do so, as I prefer that option over paying by credit card. Someone on Twitter has also asked them to be more transparent by posting total funds raised to date information.

I later also asked RIKEN about approaching locally based Aderans. Their response was as follows:

“Aderans is a partner of hair diagnostic project but not hair follicle regeneration. I would like to meet a new partner of the hair regeneration for clinical application in human.”


If you do donate to this cause, please note that the chances of any particular hair loss cure coming to realization are always abysmal. We have been disappointed over and over again for decades. I also doubt that private donations will get them more than $1 million, although I hope I am wrong.

I would suggest that the only reason to donate would be to support the overall goals of RIKEN when it comes to regenerative medicine. The implications of this work go across all of human biology. Not just hair and teeth.

Japan’s declining and aging population means that the country leads the world in anti-aging research. So these funds could indirectly benefit all of humanity. Clinical trials in Japan also proceed faster than anywhere else in the developed world. Especially when it comes to autologous regenerative medicine.

Of related interest, 10 of the 50 oldest living people in the world as of today are Japanese. That list is based on proven birth records. At the same time, Japan’s population has declined for 9 straight years, and a likely 10 straight years when new data is released.

RIKEN Tweets
RIKEN Tweets from February 11, 2021. Their hair multiplication works in human cells too.