MEDIPOST's CARTISTEM Achieves All Primary Endpoints in Japan Phase 3 Trial for Knee Osteoarthritis
核心洞察
MEDIPOST (搜索)'s stem cell therapy CARTISTEM demonstrated statistically significant improvements in both pain/function and cartilage regeneration compared to hyaluronic acid control in a 52-week Japan Phase 3 trial.
The randomized controlled study enrolled 130 participants across 13 Japanese hospitals, with CARTISTEM meeting all primary and secondary efficacy endpoints.
Results strengthen CARTISTEM's global commercial prospects, with the company planning to file a biologics license application in Japan in the second half of 2026.
MEDIPOST (搜索) announced positive results from its Japan Phase 3 clinical trial of CARTISTEM, a stem cell-based treatment for knee osteoarthritis, demonstrating statistically significant efficacy across all primary and secondary endpoints compared to standard-of-care control. The results mark a significant milestone for the South Korean biotechnology company's global expansion strategy and support plans for a biologics license application filing in Japan later this year.
Trial Design and Patient Population
The randomized, controlled study was conducted at 13 hospital sites across Japan, enrolling 130 participants with knee osteoarthritis. Patients were randomized into two groups: 59 participants received CARTISTEM treatment, while 61 participants received hyaluronic acid (HA) as the active control. The trial followed participants for 52 weeks to evaluate both efficacy and safety outcomes.
The study design ensured balanced baseline characteristics between treatment groups, with mean patient ages of 61.3 years in the CARTISTEM group and 62.2 years in the control group. Baseline clinical parameters, including Kellgren-Lawrence Grade for osteoarthritis severity, International Cartilage Repair Society (ICRS) Grade for cartilage defect severity, and pain scores, showed no statistically significant differences between groups, enhancing the reliability of the clinical findings.
Primary Endpoint Results
CARTISTEM demonstrated statistically significant improvements over the hyaluronic acid control group on both co-primary endpoints. The treatment achieved a p-value of less than 0.0001 for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which measures knee pain and function. Additionally, CARTISTEM showed significant improvements in International Cartilage Repair Society (ICRS) grade compared to control, with a p-value of 0.0002.
The results indicate that CARTISTEM not only improved patient symptoms including pain and function but also demonstrated measurable cartilage regeneration, addressing both symptomatic relief and underlying tissue repair in knee osteoarthritis.
Regulatory and Commercial Implications
Based on these positive Phase 3 results, MEDIPOST (搜索) is accelerating preparations for its biologics license application filing in Japan, scheduled for the second half of 2026. The successful completion of this pivotal trial strengthens CARTISTEM's global commercial prospects as the company continues its international expansion strategy.
MEDIPOST (搜索), led by CEO Wonil Oh, positions itself as a global leader in stem cell biotherapeutics. The Japan Phase 3 success represents an important milestone in the company's efforts to bring CARTISTEM to international markets beyond its current approvals.