Cultured Autologous Immune Cell Treatment Can Be Applied Without Prior Clinical Research

The Ministry of Health and Welfare announced that it has enacted a public notice adjusting the risk level of clinical research and treatment using cultured autologous immune cells to "low risk."

Previously in June, the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Committee deliberated on and passed an agenda item to lower the risk level, as the safety of cultured autologous immune cell research and treatment had been confirmed.

However, considering the expertise and safety of cell culture technology, a supplementary condition was attached requiring cell collection, testing, and processing to be performed at existing cell-processing facilities.

With the enactment of this notice, researchers are now able to apply for treatment plans based on literature evidence without having to go through prior clinical research, which typically takes two to three years.

Choi Kyung-il, Director-General for Advanced Medical Support at the Ministry of Health and Welfare, stated, "Following the enactment of the notice, applications for cultured autologous immune cell treatment plans can be made based on literature evidence," and added, "As we have also established review requirements for low-risk treatment plans, we ask for active participation from researchers."

(Photo provided by the Ministry of Health and Welfare, Yonhap News)
※ Please note: This article was translated by AI and may contain errors.