Clinical Research and Treatment Using Autologous Immune Cells to Improve Patient Accessibility

Ministry of Health and Welfare Enables Rapid Application for Treatment Plans Through Risk Level Adjustment

The Ministry of Health and Welfare announced on the 25th that, following a resolution by the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee, the risk level of clinical research and treatment using autologous immune cell cultivation—including natural killer (NK) cells—has been adjusted from medium risk to low risk.

As a result, researchers will now be able to promptly apply for treatment plans without having to conduct preliminary clinical research, which previously took about two to three years.

Advanced regenerative medicine refers to treatments that use human cells and other biological materials to regenerate, restore, or form human body structures and functions, or to treat and prevent diseases. This includes cell therapy, gene therapy, tissue engineering therapy, and convergence therapies. While conventional pharmaceuticals mainly focus on alleviating symptoms, regenerative medicine aims for more fundamental treatment by restoring or replacing damaged cells and tissues to their normal state.

In Korea, the enactment of the Advanced Regenerative Bio Act in 2020 established an institutional foundation, including a review system for advanced regenerative medicine and a safety management system. Last year, the introduction of the treatment system enabled actual treatment opportunities for patients with rare and intractable diseases.

Clinical research and treatment in advanced regenerative medicine are classified as high, medium, or low risk based on their impact on human life and health. Differentiated procedures are in place for each risk level, including requirements for preliminary clinical research before treatment implementation. Under current law, high- and medium-risk treatments must undergo preliminary advanced regenerative medicine clinical research with the same purpose and content (taking about two to three years), but low-risk treatments allow for rapid application of treatment plans without such preliminary research, which is expected to improve patients’ access to treatment.

The recent adjustment in risk level for clinical research and treatment involving cultured autologous immune cells is regarded as a technology with substantial safety evidence accumulated overseas, including in Japan and Taiwan. Even with the adjustment to low risk, considering the technical expertise, quality, and safety required for cell culture, the Ministry of Health and Welfare plans to revise and enforce relevant laws after review by the committee, since these treatments must be performed using processed human cells supplied from cell processing facilities rather than simple manipulations.

Kim Hyunsook, Director of Advanced Medical Support at the Ministry of Health and Welfare, stated, "The advanced regenerative medicine system improves treatment accessibility for patients with serious, rare, and intractable diseases, but it is equally important to ensure treatments are provided in a safe environment. We will thoroughly examine the safety management system and do our best to support the advancement of the system."

This content was produced with the assistance of AI translation services.