Regenerative medicine trial approved for pharynx cancer and CMV retinitis

Korean researchers can now conduct advanced regenerative medicine clinical research targeting laryngeal cancer and cytomegalovirus (CMV) retinitis.

The Ministry of Health and Welfare announced last Friday that it made this decision at the “8th Advanced Regenerative Medicine and Advanced Biopharmaceuticals Deliberation Committee for 2025.” The committee reviewed four clinical research plans submitted by institutions, including Chonnam National University Hwasun Hospital and the Catholic University of Korea Seoul St. Mary's Hospital. Among them, it approved two plans as suitable, and voted down the other two as unsuitable.

The main content of the approved proposal is a medium-risk clinical study.

The first project involves administering “SB-Immuno-Cure-HN” cells, which are treated with the glycan α-Galactosylceramide and isolated from CD14-positive cells derived from the patient's own monocytes, to patients with oropharyngeal squamous cell carcinoma in the head and neck region who have failed standard treatment.

This study aims to evaluate the safety and anticancer efficacy of SB-Immuno-Cure-HN in patients with head and neck squamous cell carcinoma by activating Natural killer T (NKT) cells.

“Natural Killer T cells (NKT cells)” refer to immune cells possessing the properties of both adaptive immune “T cells,” which recognize specific antigens, and innate immune natural killer cells, which rapidly respond to infections or tumors.

A commercially available treatment in Japan, this approach stimulates the patient's immune system to suppress tumors. It is evaluated as potentially offering a new treatment possibility for domestic patients who have not responded to existing therapies.

The second project is a medium-risk clinical study involving the administration of “autologous blood-derived cytomegalovirus antigen-specific T cells (LB-DTK-CMV)” to patients with antiviral drug-resistant and refractory CMV retinitis.

CMV retinitis occurs when CMV, which remains dormant in the body after an initial infection, reactivates due to a weakened immune system. This CMV reactivation results in increased CMV DNA levels in the blood and prolonged viremia, enabling CMV to cross the blood-retinal barrier and invade retinal tissue.

This study aims to verify safety by monitoring for adverse events following the administration of CMV-specific T cells, and to assess efficacy by measuring viral load in both aqueous humor and blood, as well as evaluating clinical symptom improvement.

Existing treatments, such as the antiviral drug ganciclovir, frequently develop drug resistance with prolonged use and can induce cross-resistance to other major antivirals, making the treatment of refractory infections even more challenging.

This research is expected to overcome the limitations of existing antiviral drugs, such as resistance and side effects, and provide patients with a treatment that fundamentally suppresses the onset and progression of refractory cytomegalovirus retinitis.

“The committee has reviewed numerous clinical studies proposing new treatments for intractable diseases,” said Kim Woo-ki, secretary-general of the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Deliberation Committee. “The secretariat will wholeheartedly support researchers throughout the entire process—from drafting research plans to submitting, receiving, and deliberating applications—to enable active attempts at advanced regenerative medicine clinical research.”