Pharmicell said Monday that the U.S. Food and Drug Administration has approved phase 1 clinical trials for its Cellgram, a liver cirrhosis stem-cell therapy.
Cellgram is a bone marrow-derived mesenchymal stem cell used to treat hepatocirrhosis. The drug is aimed at reducing fibrosis, a hardening of liver tissues damaged by alcohol, and restoring the function of the liver.
Pharmicell 파미셀 plans to start phase 1 clinical trials for patients with alcoholic cirrhosis at the University of Utah. The company has fully contacted with related U.S. contract research organizations (CRO) and contract manufacturing organizations (CMO) ahead of the trial.
“Liver cirrhosis is a serious irreversible disease that is increasing annually, but has no alternative treatment except liver transplant,” a company official said. “However, stem-cell therapy can enable fundamental treatment, which can give great hope to patients suffering from cirrhosis.”
Liver cirrhosis stem-cell therapy will become a game changer in the liver disease related market, and the company will do its best to finish the clinic trials successfully, he added.
Cellgram has already finished phase 2 clinical trials in Korea and plans to apply for a conditional license by the end of this year.
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