To revitalize advanced regenerative medicine, the government is significantly easing related regulations, such as exempting the prerequisite studies that were previously mandatory for autologous immune cell therapy.

The government will also promote government-led stem cell therapy clinical studies targeting diseases with high patient demand, such as knee osteoarthritis and chronic pain. The initiative aims to secure growth engines for the biotech industry while ensuring that patients can easily receive treatment domestically without having to travel abroad for immune and stem cell therapies.

Autologous Immune Cell Therapy Reclassified as 'Low Risk'... Faster Treatment Expected
On the 23rd, the Ministry of Health and Welfare, alongside related ministries, announced the "Measures to Rationalize Regulations to the Level of Competent Nations in the Biotech Sector."

The government has overhauled related regulations so that autologous immune cell therapy can be administered to patients more swiftly. Hitherto, autologous immune cell therapy—extracted and cultured from a patient’s own blood or cells—was classified by law as a "medium-risk" treatment. Consequently, providing direct treatment to patients in clinical settings required mandatory preliminary clinical research taking two to three years. 

As a result, many cancer patients seeking cell therapy faced years of waiting in Korea or traveled abroad, such as to Japan, where autologous immune cell culture treatment is available. Accordingly, the government is reclassifying the risk level of autologous immune cell therapy, previously deemed medium-risk, to "low risk." With this low-risk classification, treatments can be administered immediately through deliberation by the Advanced Regenerative Medicine Review Committee using literature data alone, bypassing prior clinical research. The government expects this measure to alleviate patients' burden of traveling abroad and guarantee prompt treatment opportunities.

Furthermore, individuals will now be able to receive and utilize source cells stored in cord blood banks and other facilities for research and treatment, without needing to collect source cells directly. Under current regulations, cell clinical research or treatment required source cells to be collected directly from scratch at a cell processing facility.

Even if resources such as cord blood or embryonic stem cells existed at other institutions, they could not be utilized, limiting source material supply and research. In response, the government has decided to amend the "Act on Safety of and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals" so that source cells stored in other institutions can be provided and utilized without direct cord blood collection.

Measures have also been prepared to revitalize stem cell therapy and strengthen the review infrastructure for advanced regenerative medicine. The government has decided to directly lead clinical research on knee osteoarthritis, chronic pain, and other conditions that experience high public demand and frequent overseas patient travel.

Over the next two years, the safety and efficacy of stem cell therapy will be verified through a government-led clinical study involving 330 participants. In addition, the government plans to split the review committee for advanced regenerative medicine research and treatment agenda items according to risk levels. While a "single" review committee previously handled batch reviews, the committee will now be divided into two—high-risk and medium-to-low risk—to enhance expertise, alongside introducing a fast-track review process for identical and recurring treatment plans.

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