Seoul, Mar. 24 (BNA): Nature Cell, a South Korean stem cell therapy company, has announced the Topline results of the phase 3 clinical trial efficacy evaluation of ‘JointStem’.
JointStem is the world’s first treatment for severe knee degenerative arthritis using autologous adipose-derived mesenchymal stem cells, which is being developed by its affiliate Rbio.
Following an analysis of the efficacy evaluation data by LSK Global PS, a clinical research organization (CRO), both the primary evaluation indicators, WOMAC (osteoarthritis index) and VAS (pain index), were statistically significantly improved compared to placebo, confirming its superiority.
In the case of WOMAC, patients receiving JointStem decreased by 521.56 points (P value <0.0001) from an average of 1,374.69 before administration to 849.39 points after 24 weeks of administration. The treatment effect was also statistically significantly improved (P value = 0.0002) in comparison with the placebo-treated group, the company said.
In addition, in the case of VAS, patients receiving JointStem decreased by 25.16 points from an average of 57.74 points before administration to 32.65 points after 24 weeks of administration (P value <0.0001). In comparison with the placebo-treated group, it was also confirmed that the pain decreased statistically significantly (P value <0.0001).
In statistical analysis, the P value, an index that evaluates that if the result is less than 0.05, it is a success, and if it exceeds 0.05, it has failed to secure statistical significance, was significantly lower than the reference value.
JointStem, developed by Rbio and owned by Nature Cell, is a stem cell therapy that treats severe degenerative arthritis patients with K-L grade 3 or higher with a single injection.
In May 2008, it was approved by the South Korean Ministry of Food and Drug Safety (KFDA) for phase 1 and 2 clinical trials, and phase 2b clinical trials in 2014, followed by approval for phase 3 clinical trials in January 2019. In addition, it has completed phase 2 clinical trials in the United States, and has recently received approval for a phase 2b/3a clinical plan from the FDA.
In phase 3 clinical trials conducted at 13 university hospitals nationwide, including Seoul National University Hospital, Severance Hospital, and Kyung Hee University Hospital at Gangdong, 261 patients with severe degenerative arthritis were enrolled.
Of these, the final 252 patients, excluding those who dropped out and the withdrawal of consent, were randomly assigned to receive JointStem or placebo while maintaining double-blindness.
Through follow-up observation for six months, various evaluations were conducted for efficacy and safety including WOMAC and VAS.
“We will receive the final result report by May 2021, and will prepare well for the application for new drug approval," Dr. Ra Jeong-chan of the Biostar Stem Cell Research Institute, who is also in charge of JointStem research and development, said.