Korea’s Biostar Stem Cell Research Institute said on Aug. 28 it plans to commercialize its stem cell-based therapy for osteoarthritis patients in December that helps to repair damaged joints.
The drug candidate JointStem is an injection designed to be administrated into the glenoid cavity of patients with severe degenerative arthritis to renew their cartilage, alleviate pain, and improve joint functions.
“In the clinical trials in Korea and the United States, we found significant improvement for over 90 percent of participants’ conditions,” Ra Jeong-chan, a director at Biostar Stem Cell Research Institute, co-operated by biotech companies Nature Cell and R-Bio, said during a press conference held in Seoul.
Osteoarthritis is the most common chronic condition of the joints, affecting approximately 2.5 million Koreans. The drug candidate could offer non-surgical alternative to patients with severe conditions who are required to replace damaged joints with artificial ones.
Nature Cell, headed by Ra, is awaiting the Ministry of Food and Drug Safety’s decision for conditional approval of the drug, which completed phase 2 clinical trials here. It plans to launch the therapy in the US by 2021 after completing phase 3 clinical studies.
Generally, medicines can only be authorized after phase 3 of clinical trials, but in Korea and Japan, some proposed drugs, including rare disease treatments and severe irreversible diseases, can receive conditional marketing approval even without the last stage studies.
In the clinical trials conducted at Boramae Hospital in Seoul for the last two years, a total of 15 patients who were treated with 100 million autologous stem cells showed statistically significant improvement in knee function, pain and quality of life assessment, Ra said.
By Park Han-na (email@example.com)