[Expert Column] Aiming for First Regenerative Medicine Institution Designation as a Stem Cell Cosmetic Institution in Line with Amendment to 'Advanced Biomedical Engineering Act'

The amendment to the 'Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals' (the Advanced Biopharmaceuticals Act or the Advanced Regenerative Medicine Act) passed the plenary session of the National Assembly on the 1st and was promulgated after being approved by the Cabinet on the 20th.

Starting February 20 of next year, which marks one year from the date of promulgation, regenerative medicine institutions designated by the Minister of Health and Welfare to practice advanced regenerative medicine will be able to supply cells derived from the patient themselves as raw materials for advanced biopharmaceuticals through minimal operations such as simple separation, washing, freezing, and thawing.

In addition, if there are patients with serious, rare, or intractable diseases who desire cell or gene therapy, they can receive treatment at government-designated regenerative medicine institutions at their own expense through general treatment rather than clinical trials.

As someone who has been researching stem cell breast augmentation, stem cell facial surgery, and stem cell anti-aging therapy since 2007, I consider the government's active policy to be a welcome policy encouragement, like "rain in a drought." It is expected that this will enable related medical institutions, which have solidified their technological capabilities, to focus on technology development in a stable manner, and that the industrialization of the medical sector will lead to the creation of more added value and jobs.

In 2007, I opened the 'Stem Cell Transplantation Plastic Surgery Research Institute,' the first of its kind among plastic surgery clinics in Korea. While founding and serving as president of the Korean Society of Stem Cell Plastic Surgery, I held at least two academic seminars annually, combined with live surgery demonstrations, until the mid-2010s to teach stem cell breast fat grafting techniques.

After using all sorts of advanced equipment, including manual, semi-automatic, and automatic systems, to extract high-purity stem cells, it has now been discovered that the best results are achieved when specialized personnel with know-how extract the stem cells using a manual method.

Furthermore, they have mastered the know-how that combining stem cells and fat cells in a golden ratio and transplanting them into breast or facial areas lacking volume in the shortest possible time can maximize the engraftment rate and lower the risk of infection.

Through trial and error, the surgical technique stabilized starting in 2009, enabling the achievement of the current engraftment rate of over 70%. The engraftment rate is the core of stem cell surgery. Currently, most "pseudo" stem cell surgeries in Korea involve diluting stem cells with water, injecting fat cells instead of stem cells, or injecting platelet-rich plasma (PRP) instead of high-purity stem cells. With such superficial surgeries, the engraftment rate remains at best around 15%.

After strenuous efforts, I have accumulated clinical experience in 8000 cases of stem cell plastic surgery. Following the publication of a paper in the 'University of Oxford Journal' in February 2020, I achieved international recognition by publishing a paper in April 2023 in 'Annals of Plastic Surgery,' an SCI-indexed journal in the American field of plastic surgery, stating that the average stem cell engraftment rate reached 77.48%.

The advancement of stem cell cosmetic surgery required not only personal effort but also massive investment. As a private practitioner, I was the first in Korea to introduce sterile operating rooms, 3D volume imaging equipment, and stem cell counters related to stem cell surgery. In 2017, I also became the first private clinic to acquire an ultra-low temperature cell banking system (storage in liquid nitrogen at minus 196 degrees Celsius) capable of long-term storage of stem cells needed for overcoming intractable diseases and anti-aging treatments. My clinic is the only private practice in Korea equipped with all four types of advanced stem cell extraction equipment from companies C, M, H, and T. Over a billion won was invested in this infrastructure.

The result is an average engraftment rate of 77.48%, which is more than seven times the engraftment rate (10–15%) of simple autologous fat grafting. This has achieved an innovation that provides the desired volume without revision surgery to medical consumers who have experienced the bitter taste of failure in breast augmentation surgery using conventional autologous fat grafting.

I have begun preparations for SC301 Clinic to be designated as a regenerative medicine institution by the Ministry of Health and Welfare in accordance with the amendment to the Advanced Regenerative Medicine Act set to take effect next February. Having already met the external requirements, such as infrastructure, I can assess that we have already crossed the 2% mark. Only the drafting of detailed technical documents remains.

With the passage of the amendment to the Advanced Biomedical Research Act, we plan to explore various indications, such as cancer and intractable or rare diseases, based on high-purity stem cell therapeutic materials. At the same time, we intend to accelerate efforts to revitalize the attraction of overseas patients, including those from China, which had entered a lull due to the COVID-19 pandemic in 2020.

As a beneficiary of the amendment to the Advanced Biomedical Research Act, I intend to fulfill my given mission as a pioneer in stem cell regenerative medicine, specifically in stem cell breast augmentation that enhances body aesthetics and anti-aging treatments that enable the delay of aging. It would be ideal if I could fully meet the unsatisfactory medical needs of individuals and serve as a catalyst for the industrialization of the medical sector.