Company
Business
Stem Cell Therapy
Organoid
CDMO Business
IR Resource Center
Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Results of 12-month long-term follow-up visit to OSCA Phase 1 clinical trial
19
2025.03
The clinical phase 1 high-dose group of the osteoarthritis treatment ‘OSCA’ completed a 12-month long-term follow-up visit.
The clinical phase 1 high-dose group of the osteoarthritis treatment ‘OSCA’ completed a 12-month long-term follow-up visit. In the evaluation of pain control and joint function after a single intra-articular injection, as with the 6-month mark, there were patients in both the medium and high-dose groups who showed either maintained or improved results at the 12-month point.
Kangstem Biotech employed several efficacy evaluation variables to assess improvements in pain and knee function. The VAS assessed pain experienced over the past 24 hours, the WOMAC evaluated osteoarthritis symptoms over the past 48 hours, the KOOS measured pain, joint function, and quality of life over the past week, and the IKDC evaluated knee function and activity over the past 4 weeks.
As a result, we confirmed that the pain and joint function improvements observed shortly after treatment in the medium and high-dose groups were maintained or even improved for some patients at the 12-month mark, confirming the potential for OSCA as a fundamental treatment.
In MRI imaging assessments, MOCART, which evaluates the improvement of the most damaged areas of the knee joint, showed improvement or no progression of damage(7 out of 10 improved, 1 showed no change) at the 6-month point for most patients.
In the overall structural evaluation of the knee joint through WORMS, structural improvements such as cartilage, subchondral bone regeneration, cysts, and synovitis were observed. For the low and medium-dose groups, whose 12-month imaging evaluations have been completed, the effects seen at 6 months were either maintained or showed further improvement. The analysis of the entire imaging data, including the high-dose group, will be completed after mid-April.
Furthermore, the clinical 1st phase results of OSCA, including MRI images, will be presented at the OARSI(Osteoarthritis Research Society International) conference in Songdo this April, and the 12-month data and results will be presented at the ISAKOS(International Society of Arthroscopy, Knee Surgery, and Orthopaedic Sports Medicine) conference in Munich, Germany this June.