Advanced regenerative medicine based on patients' immune cells, which had required years of preliminary clinical research, will now be able to be implemented without going through that process. As treatment procedures are streamlined, patients' access to care is expected to improve.
The Ministry of Health and Welfare said on the 25th that it has adjusted the risk level of advanced regenerative medicine clinical research and treatment that cultures and uses patients' own immune cells, such as natural killer cells (NK cells), from "medium risk" to "low risk."
The measure was finalized after a resolution by the Review Committee on Advanced Regenerative Medicine and Advanced Biopharmaceuticals. As a result, researchers can apply for treatment plans without preliminary advanced regenerative medicine clinical research, which takes about two to three years.
Advanced regenerative medicine is a medical technology that uses human cells and the like to regenerate and restore damaged tissues and functions or to treat and prevent disease. It includes cell therapy, gene therapy, tissue engineering therapy, and convergence therapies. While conventional pharmaceuticals focus on alleviating symptoms, advanced regenerative medicine aims for fundamental treatment by restoring or replacing damaged cells and tissues to a normal state.
The current Advanced Regenerative Bio Act classifies advanced regenerative medicine into high-, medium-, and low-risk categories by risk level. High- and medium-risk treatments must conduct preliminary clinical research with the same purpose. In contrast, low-risk treatments can apply for treatment plans based on existing clinical results or literature without preliminary clinical research.
The adjustment to the risk level for autologous immune cell culture therapy reflects that the technology has accumulated safety evidence and treatment cases in Japan and Taiwan. The ministry plans to pursue revisions to the relevant notices and laws based on the review committee's resolution.
However, even if the risk level is adjusted to low risk, the cell culture process requires expertise and safety assurance, so the system will be revised to supply and use human cells cultured at cell processing facilities.
The ministry expects this measure to enhance treatment access for patients with rare and intractable diseases.
Meanwhile, the review committee also approved three multicenter advanced regenerative medicine clinical studies targeting solid cancers, musculoskeletal diseases, and chronic pain. These studies are government-planned projects aimed at shifting demand for overseas treatment trips back to the domestic market.
Kim Hyun-suk, director for advanced medical support at the ministry, said, "The advanced regenerative medicine system is meaningful in improving treatment access for patients with serious, rare, and intractable diseases," and added, "We will closely inspect the safety management system so that patients can receive treatment in a safe environment and will continue to develop the system."