Health ministry clears cell therapy trial for terminal colorectal cancer

The health ministry said Friday it had approved a clinical study that will test whether a patient's own immune cells can be used to treat metastatic or recurrent terminal colorectal cancer, a disease for which standard treatments have been exhausted.

The approval covers one of three clinical research plans submitted by regenerative medicine institutions to the 11th Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee, which met on Oct. 22. The committee found one plan suitable and rejected two.

In the approved study, researchers will draw blood from patients whose disease has spread to organs such as the liver, lungs or peritoneum, and separate out natural killer cells and T lymphocytes. The cells will be cultured for a set period and then administered in sequence.

The trial is classified as medium-risk cell therapy. The ministry described T lymphocytes as white blood cells that attack cancer cells or virus-infected cells, and natural killer cells as part of the innate immune system that recognize and destroy abnormal cells such as tumors.

The researchers will first check the treatment's safety, then measure clinical effects including the disease control rate and progression-free survival.

"In this review, we examined advanced regenerative medicine plans for difficult-to-treat diseases such as terminal colorectal cancer," said Kim Dong-ik, chairman of the committee. "The committee will closely examine the validity of implementation plans based on scientific evidence so that new treatment possibilities can open for patients with serious, rare and intractable diseases."

Kim added that the committee would do its utmost in its review to secure safety so that advanced regenerative medicine can be applied to patients safely.