The first-ever case has been approved to use advanced regenerative medicine to treat patients with rare and intractable diseases.
The Ministry of Health and Welfare said on the 24th that a treatment plan submitted by The Catholic University of Korea Yeouido St. Mary's Hospital for patients with complete remission of a rare lymphoma at high risk of relapse was deemed appropriate by the Committee on Advanced Regenerative Medicine and Advanced Biopharmaceuticals.
It comes 1 year and 2 months after the amended Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act (Advanced Bio Act, Regenerative Medicine Act) took effect in Feb. 2025. Advanced regenerative medicine is an innovative therapy that restores damaged human functions using cells, tissues, genes, and more.
The approved treatment is VT-EBV-N, an autologous immune cell therapy developed by ViGenCell. It targets patients with EBV (Epstein-Barr virus)-positive NK/T-cell lymphoma who reached complete remission with no cancer visible on imaging after finishing anticancer treatment but face a high risk of relapse.
The method is to produce and administer special T cells (immune cells) made to recognize EBV antigens from the patient's own immune cells. The goal is to administer EBV-specific immune cells to remove residual cancer cells and suppress relapse.
The treatment will be conducted by Yeouido St. Mary's Hospital of The Catholic University of Korea, with hematology professor Jeon Young-woo serving as principal investigator. The total number of participants is 15. The treatment will be implemented for two years following the Industrial Convergence Regulatory Special Case Review Committee's resolution and notice, and may be extended.
The treatment expense is set at 76.207178 million won. Patients pay 40 million won at treatment, and an additional 30 million won if no relapse occurs within five years. However, if relapse occurs within five years after treatment, the full amount is refunded.
The ministry said a new treatment is needed because the disease has a high relapse rate despite chemotherapy and radiation therapy, and the risk of death increases significantly upon relapse.
Kim Hyun-suk, director general for advanced medical support at the Ministry of Health and Welfare, said, "With the first approval for advanced regenerative medicine treatment, we expect to offer a new treatment opportunity to patients with rare lymphoma at high risk of relapse."
Kim said, "The first approval of this treatment is significant in that the advanced regenerative medicine treatment system has begun in clinical settings," and added, "We will continue to strengthen support, including institutional improvements, so that advanced regenerative medicine treatments can be implemented smoothly to meet unmet medical needs."
Jeon Young-woo, the treatment lead and a professor at Yeouido St. Mary's Hospital, said, "Phase 2 results for VT-EBV-N confirmed its treatment effect and safety, and we determined it could be a meaningful treatment option for patients at high risk of relapse." Jeon said, "We are very pleased that it can be applied early to patients in real clinical settings."
ViGenCell CEO Ki Pyeong-seok said, "Through the nation's first approval of a treatment plan, we find it very meaningful that the clinical value of VT-EBV-N and the need for relapse-prevention treatment have been reaffirmed," and added, "We will continue to work closely with medical institutions to provide necessary treatment opportunities to patients and to pursue conditional item approval and technology transfer for VT-EBV-N."
This treatment was submitted through a planning-type regulatory sandbox that allows applications for review of advanced regenerative medicine treatment plans based on results from commercial clinical trials. The treatment plan was submitted based on phase 2 results, and following the committee's decision of appropriateness, treatment is set to proceed after review by the Industrial Convergence Regulatory Special Case Review Committee.