Pamisel Selected for Cellgram-LC Advanced Regenerative Medicine Clinical Research Project

Pharmicell announced on the 29th that its stem cell therapy Cellgram-LC is being used in an advanced regenerative medical clinical research project selected by the Advanced Regenerative Medicine and Advanced Biopharmaceutical Review Committee under the Ministry of Health and Welfare.

The project involves using mesenchymal stem cells isolated from the patient's own bone marrow to treat patients with liver cirrhosis accompanied by ascites. The goal is to improve quality of life by controlling ascites in patients who have no treatment options other than liver transplantation.

The clinical trial will involve 20 patients with liver cirrhosis accompanied by ascites. The process includes isolating and culturing mesenchymal stem cells from the patients' own bone marrow, followed by direct injection into the liver through the hepatic artery. The research team plans to evaluate efficacy and safety by comparing improvements in liver function, liver fibrosis, and ascites.

Professor Jae-Young Jang of Soonchunhyang University Seoul Hospital, who is conducting the study, said, "The mortality rate of patients with liver cirrhosis is higher than that of patients with the top five cancers, but there are no drug treatments available." He added, "Even controlling ascites caused by liver cirrhosis can improve patients' quality of life, so we hope to confirm the efficacy of ascites control."

A Pharmicell representative introduced Cellgram-LC as "currently undergoing Phase 3 commercialization trials" and "a therapy whose safety and efficacy have been confirmed through previous clinical trials." They further explained, "Through this research project, we aim to expand indications not only to alcoholic liver cirrhosis but also to liver cirrhosis accompanied by ascites," and added, "We hope this will provide treatment possibilities for patients who have no other alternative therapies."

Pharmicell has obtained manufacturing approval for advanced biopharmaceuticals from the Ministry of Food and Drug Safety in accordance with the enforcement of the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals.