Kangstem Biotech has secured the final report from its Phase 2a clinical trial for a stem cell treatment targeting knee osteoarthritis. The company is now accelerating subsequent clinical trials and global technology transfers. In addition to reaffirming pain relief and improved joint function, magnetic resonance imaging (MRI) analysis results suggest potential improvements in joint structure.
On Tuseday, Kangstem Biotech announced the receipt of the final clinical study report (CSR) for its knee osteoarthritis treatment OSCA (PureStem-OA Kit). This comprehensive report includes the main clinical results disclosed in July, along with additional analysis findings.
The trial encompassed 113 patients with moderate knee osteoarthritis, comparing mid-dose and high-dose OSCA groups against a placebo group. The company reports that OSCA treatment groups demonstrated statistically significant differences in various metrics assessing pain and knee function compared to the placebo group at the 24-week mark. Notably, improvements were observed as early as 4 to 12 weeks post-treatment and persisted through week 24.
MRI-based assessment of joint structure also yielded promising results. The MOCART 2.0 total score, which evaluates cartilage repair tissue condition, showed statistically significant improvement in the mid-dose group compared to the placebo. The WORMS analysis, which evaluates joint structure changes, observed positive shifts in certain indicators, including bone marrow lesions.
While these results suggest the possibility of improved joint structure, further verification in subsequent clinical trials is necessary to definitively prove cartilage regeneration or disease progression inhibition. The company also noted changes in inflammatory cytokines and cartilage metabolism-related biomarkers, providing a foundation for exploring the treatment’s mechanism of action.
Leveraging this final report, Kangstem Biotech aims to refine its subsequent clinical development and global commercialization strategies. The company plans to conduct long-term follow-ups to assess the durability of effects and changes in joint structure, as well as present research findings at international conferences. Next year, they will engage in pre-consultation discussions with the U.S. Food and Drug Administration (FDA) to shape the design of follow-up clinical trials and key evaluation criteria.
Simultaneously, Kangstem Biotech will continue negotiations for technology transfers and joint development with global pharmaceutical and biotech firms. The company intends to utilize the clinical results and additional analysis data from the final report in negotiations with potential partners.
A Kangstem Biotech spokesperson stated that the final report has reinforced the consistency of the existing top-line results. With data indicating not only pain relief and functional improvement but also potential joint structure enhancements based on MRI, it’s poised to refine the subsequent clinical development and effectively communicate OSCA’s clinical value to global partners.
In the near term, Kangstem Biotech plans to present these clinical results at the upcoming ACR Convergence in Florida this November. Looking ahead, the 12-month follow-up results are slated for disclosure at the 202 EULAR and ISAKOS conferences.
