The Ministry of Health and Welfare announced on Friday that it has adjusted the risk level for clinical research and treatment involving autologous immune cell cultivation, including natural killer (NK) cells. This decision follows a resolution by the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee on Thursday.
Previously categorized as medium risk, autologous immune cell cultivation in advanced regenerative medicine has been reclassified as low risk. This change enables researchers to swiftly apply for treatment plans without the need for preliminary clinical studies, which typically take about 2-3 years.
Despite the low-risk classification, the Ministry emphasizes that cell cultivation must be conducted in specialized facilities to ensure quality and safety, rather than through simple operations. Consequently, the Ministry plans to amend and implement relevant regulations based on the committee’s review results.
Advanced regenerative medicine uses human cells to regenerate, restore, or form body structures and functions, as well as to treat or prevent diseases. This field includes cell therapy and gene therapy. While pharmaceuticals primarily focus on symptom relief, regenerative medicine aims for more fundamental treatment by restoring or replacing damaged cells and tissues.
Clinical research and treatments in advanced regenerative medicine are categorized as high, medium, or low risk, depending on their potential impact on human life and health. The procedures are differentiated based on these risk levels, with high and medium-risk treatments requiring prior clinical studies. Low-risk treatments, however, can quickly apply for treatment plans without preliminary studies, improving patient access to care.
Under current law, high and medium-risk treatments must conduct preliminary clinical research with the same purpose and content. Low-risk treatments, on the other hand, can expedite the application process, potentially enhancing patient access to treatment.
The clinical research and treatment involving autologous immune cell cultivation will be finalized through the Ministry’s announcement following the committee’s review. Additionally, the committee approved three multi-center clinical studies aimed at redirecting the demand for overseas treatments back to the country. These studies target diseases with significant public demand, as part of a government initiative.
Kim Hyun-sook, the Ministry’s Director of Advanced Medical Support, stated that while the advanced regenerative medicine system enhances treatment accessibility for patients with serious, rare, and intractable diseases, ensuring patient safety remains paramount. It will carefully review the safety management system and strive to improve the overall framework.