[Asia Economy Reporter Hyunseok Yoo] Pharmicell announced on the 3rd that it has obtained approval from the Korea Ministry of Food and Drug Safety for the commercialization of the phase 3 clinical trial of the cirrhosis stem cell therapy Cellgram-LC.
Pharmicell's Cellgram-LC is an injectable drug using 'autologous bone marrow-derived mesenchymal stem cells' that is expected to improve fibrosis of liver tissue damaged by alcohol and restore liver function.
This phase 3 clinical trial will be conducted on a total of 200 patients with alcoholic cirrhosis. One hundred patients will be randomly assigned to the 'treatment group' receiving autologous bone marrow-derived mesenchymal stem cells, and 100 patients to the 'control group' receiving only the best supportive care, to evaluate the efficacy and safety of the treatment.
A company official stated, “Cellgram-LC’s investigator-initiated clinical trial results have been published in the official international journal of the World Association for the Study of the Liver, Liver International, and the phase 2 clinical trial results were published in Hepatology, the official journal of the American Association for the Study of Liver Diseases, receiving global academic attention and recognition. As this is a highly anticipated therapeutic agent, we will focus our capabilities on successful commercialization.”
Currently, aside from conservative therapies that prevent loss of liver function, liver transplantation is the only treatment for cirrhosis. However, liver transplantation has many limitations such as donor shortages and risks of complications. This is why the development of stem cell therapies that can structurally supplement damaged liver function is required.
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