Groundbreaking Results in Knee Arthritis Treatment

On this 17th, Nature cell achieved success in a third phase clinical trial for “JointStem,” the world’s first knee degenerative arthritis medication based on mesenchymal stem cells extracted from autologous fat that is in development by RBio.

JointStem has been developed using domestic original technology. It is innovative because it only requires one injection to treat degenerative arthritis without the need for similar medications or surgery.

According to Nature Cell, clinical trial results from LSK Global PS, a contract research organization, that was received on the 14th confirmed statistically significant pain reduction and joint function improvement as well as safety in K-L3 level knee degenerative arthritis.

Osteoarthritis Index (WOMAC) and pain index (VAS), which are the primary endpoints of JointStem, significantly improved in each index 24 weeks after the injection compared to pre-dose. P-values below 0.05 are considered not statistically significant in general statistical analysis. However, JointStem showed significantly lower values than reference values in both endpoints. In particular, the two endpoints had p=0.0002, p<0.0001 respectively, which are both significantly large.

Moreover, the secondary endpoints, including subgroups of WOMAC (pain and stiffness, difficulties in performing daily activities), KOOS (Knee Injury and Osteoarthritis Outcome Score), SF-36 (Assessing quality of life), X-rays and MRI, and evaluations of uses and dosages of the drug, have shown clear improvements.

MRI analysis also revealed that the depth and surface area of cartilage defect, size of the damage in bone marrow, damage in subchondral bone, size of the subchondral cyst, and improvement or maintenance of subchondral cyst were higher in the group injected JointStem than the control group.

“There has been no significant adverse reaction that can be attributed to JointStem,” said CEO Ra Jeong Chan. He explained, “JointStem will prepare the quality and GMP aspects of the licensing process and apply for drug approval within a few months.”