GC녹십자랩셀, Application for Phase 1 Clinical Trial of Acute Respiratory Distress Syndrome Treatment in Korea

CT303, Indication Expanded to ARDS Following Psoriasis

[Asia Economy Reporter Kim Ji-hee] GC Green Cross LabCell announced on the 23rd that it has applied to the Ministry of Food and Drug Safety for the clinical trial application (IND) of ‘CT303,’ a candidate drug for the treatment of acute respiratory distress syndrome (ARDS).

This Phase 1 clinical trial is designed to evaluate the safety, tolerability, and efficacy of a single dose of CT303 in 8 patients. The trial will be conducted at Seoul National University Hospital, Bundang Seoul National University Hospital, and Seoul Metropolitan Boramae Hospital.

ARDS, known as a major cause of death in COVID-19 patients worldwide, is respiratory distress caused by fluid accumulation in the lungs due to trauma, infection, or lung disease. The mortality rate is about 45%, but there is currently no effective treatment, making it a medically challenging disease with high demand, according to the company.

CT303 was manufactured using tonsil tissue collected from healthy donors under the age of 10. It is expected to be effective for ARDS patients who exhibit excessive inflammatory responses and cell death by utilizing its immune regulation and tissue regeneration promotion capabilities.

GC Green Cross LabCell has verified in ARDS animal models that CT303 reduces neutrophil infiltration and inflammatory cytokine expression, confirming that CT303 administration can reduce pulmonary edema and thrombosis and improve damaged alveolar structures.

Hwang Yu-kyung, Director of the Cell Therapy Research Institute at GC Green Cross LabCell, said, “Following the recent IND approval for CT303 in psoriasis, we plan to expand its indications to acute respiratory distress syndrome and actively pursue the development of stem cell therapies.”

Park Dae-woo, CEO of GC Green Cross LabCell, said, “We will do our best to promptly provide the treatment to patients by ensuring the safety and efficacy of CT303.”

This content was produced with the assistance of AI translation services.