Pharmicell said that the Ministry of Food and Drug Safety has approved its phase 2 trial of Cellgram-ED, a stem-cell therapy for treating erectile dysfunction.
Cellgram-ED is an injection that promotes the regeneration of damaged nerves and spontaneous angiogenesis inside the corpus cavernosum. It is one of two columns of spongy tissue that runs through the shaft of the penis and the area related to erectile dysfunction, using the autologous bone marrow-derived mesenchymal stem cells.
The multicenter and randomized phase 2 clinical trial will confirm the efficacy and safety of the drug in 54 patients who have erectile dysfunction after receiving prostatectomy.
“As the safety of administration has been confirmed through previous clinical studies, the phase 2 clinical trial aims to increase the reliability of Cellgram-ED and to evaluate the effectiveness of drugs objectively,” the company said. “Erectile dysfunction is currently lacking fundamental treatments worldwide as about 30-50 percent of erectile dysfunction patients do not show any efficacy toward existing oral drugs.”
The company expects that the treatment will offer a new solution to refractory erectile dysfunction, which was incurable with existing drugs, it added.
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