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Kangstem Biotech Publishes Phase 1 Clinical Results of OSCA in a Nature Portfolio Journal
04
2026.05
- Peer-Reviewed Data Demonstrate OSCA's Potential as a Disease-Modifying Osteoarthritis Drug (DMOAD)
Kangstem Biotech announced that the Phase 1 clinical trial results of its investigational knee osteoarthritis treatment, OSCA, have been published in the international scientific journal, Experimental & Molecular Medicine(EMM).
EMM is an international journal under the Nature Publishing Group that focuses on innovative therapeutic strategies bridging molecular and cellular medicine with both basic and clinical research. It has an Impact Factor(IF) of approximately 13, and journals with an IF above 10 are generally regarded as highly influential and prestigious within the academic community.
The published study reports the results of a Phase 1 clinical trial of OSCA administered as a single intra-articular injection in patients with knee osteoarthritis. The findings demonstrated not only an excellent safety profile, but also trends toward improvement in pain and functional outcomes, particularly in the mid-dose and high-dose groups. In addition, MRI-based analyses revealed signals indicative of cartilage structural improvement, suggesting the potential to go beyond symptomatic relief and address underlying disease structure.
These results are interpreted as early clinical evidences supporting OSCA’s potential as ‘DMOAD’, a category for which no definitive therapy currently exists in knee osteoarthritis. In particular, OSCA’s mechanism—combining cell therapy with cartilage acellular matrix—differentiates it from conventional symptom-focused treatments by potentially improving the damaged cartilage microenvironment and promoting tissue regeneration.
The Head of Clinical Development at Kangstem Biotech stated, “The publication in EMM is highly meaningful as it represents international academic recognition of OSCA’s safety and its potential structural improvement effects. We believe this will also play an important role in future development strategies and global licensing opportunities.” He added, “According to our recently analyzed 24-month follow-up study from the Phase 1 trial, participating patients have shown sustained improvements in pain and joint function for up to two years post-treatment. Notably, imaging-based endpoints indicate that structural improvements become more pronounced over time, which clearly differentiates OSCA from existing therapies.”
Meanwhile, the ongoing Phase 2a clinical trial of OSCA aims to validate statistical significance through a randomized study involving both the investigational drug and placebo in 113 patients—approximately ten times larger than the Phase 1 study. Patient dosing was completed last November, and topline data are expected to be announced around the end of July. The company stated that, based on statistical simulations incorporating placebo effects reported in prior studies, the Phase 2a results are expected to be highly encouraging.