GC Lab Cell said Thursday that it has won the Ministry of Food and Drug Safety’s approval for phase 1 clinical trial of CT303, a candidate substance of stem cell therapy for psoriasis.
The company submitted an investigational new drug (IND) application for the trial in June.
The trial is designed to analyze the safety, and drug tolerance of repetitive single dose administers of CT303 (human tonsil-derived mesenchymal stem cell) on 24 moderate-to-severe plaque psoriasis (PsO) patients. It will proceed at multiple institutions with an increasing quantity. The institutions include Seoul National University Hospital, Pusan National University Hospital, CHA University, and CHA Bundang Medical Center.
Psoriasis, a chronic inflammatory autoimmune disease, has a prevalence rate of 3 percent worldwide. About 1.5 million Koreans are estimated to have the condition. Because of the shape or formation of the lesions, it considerably affects patients' lives, causing emotional difficulties.
GC Lab Cell said CT303 was manufactured using tonsil-derived tissue from healthy donors aged below 10 years. By controlling the excessive immune reaction, it helps improve psoriasis symptoms.
“CT303 is an advanced platform technology that has maximized anti-inflammatory effects compared to preexisting mesenchymal stem cell therapies. We can also develop additional indications treating other inflammatory diseases,” said Hwang Yu-kyung, director of GC Lab Cell’s Cell Therapy Research Center.
GC Lab Cell CEO Park Dae-woo also said, “As we have focused on developing a differentiated stem cell therapy with natural killer cell therapies, beginning with psoriasis treatment, we will enter additional clinical trials for autoimmune disease or acute inflammatory disease treatment by the second half of the year.”
GC Lab Cell has researched the massive production, subculture, and freezing of tonsil-derived stem cells using NK cell therapy know-how. The company has developed tonsil-derived stem cells with strengthened anti-inflammatory abilities proven for their effects on the regenerating tissues and reducing the cause of psoriasis through animal model experiments, the company said.