Pamisel, Erectile Dysfunction Stem Cell Therapy Phase 2 Clinical Trial Approved

[Asia Economy Reporter Hyungsoo Park] Pharmicell announced on the 12th that it has obtained approval from the Korea Ministry of Food and Drug Safety for the commercialization of the erectile dysfunction stem cell therapy ‘Cellgram-ED’ for Phase 2 clinical trials.

Pharmicell's Cellgram-ED is an injectable drug using ‘autologous bone marrow-derived mesenchymal stem cells’ that is expected to promote regeneration of damaged nerves and neovascularization within the corpus cavernosum, which are causes of erectile dysfunction. Phase 1 clinical trials began in December 2015 and were completed in January 2018.

Through Phase 2 clinical trials, the efficacy and safety will be confirmed in a total of 54 patients suffering from erectile dysfunction after prostatectomy.

A Pharmicell official stated, “We confirmed safety through preliminary clinical studies, and in Phase 2 clinical trials, we aim to increase the reliability of Cellgram-ED by targeting a larger number of subjects and objectively evaluate the drug’s efficacy.”

Regarding the background of developing Cellgram-ED, they explained, “Erectile dysfunction currently has no fundamental treatment worldwide. Even injection therapy with vasodilators into the corpus cavernosum has the limitation of only temporary effects, so ultimately surgery to implant a penile prosthesis is necessary.”

They added, “Cellgram-ED will present a new solution for refractory erectile dysfunction that could not be treated effectively with existing drugs.”

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