Medipost Reports Positive Phase 3 Results for CARTISTEM in Japan’s Knee Osteoarthritis Trial

(서울=뉴스1) 문대현 기자 = Medipost announced on Wednesday that its umbilical cord-derived allogeneic mesenchymal stem cell therapy, CARTISTEM®, has successfully met all primary and secondary efficacy endpoints in its Phase 3 clinical trial in Japan. The results confirmed significant improvements in clinical pain relief, functional recovery, and cartilage regeneration.

This breakthrough demonstrates Medipost's global competitiveness in Japan, a country with one of the world's highest proportions of elderly citizens aged 65 and above. The company is now poised to accelerate its application for product approval in the latter half of the year.

Medipost held a press conference at the Four Seasons Hotel in Seoul's Jongno district to unveil the results of CARTISTEM's Phase 3 clinical trial for knee osteoarthritis treatment in Japan.

Lee Seung-jin, Head of Global Business and Chief Executive Officer (CEO) of the Japanese subsidiary, reported that they've achieved clear statistical significance across all primary and secondary efficacy endpoints in the Japanese Phase 3 trial.

Lee added that the Japanese Phase 3 results reaffirm CARTISTEM's exceptional efficacy and safety profile. The consistency observed across both primary endpoints and all secondary variables is particularly significant from a clinical perspective.

According to Lee, the Japanese Phase 3 trial demonstrated statistically significant results across all primary and secondary efficacy endpoints, marking a clinical success.

The Phase 3 trial in Japan involved 130 patients with moderate to severe knee osteoarthritis (Kellgren–Lawrence Grade 2-3) across 13 medical institutions. Participants were divided into two groups: 59 patients received CARTISTEM, while 61 received hyaluronic acid (HA) injections.

The trial was designed as an open-label, randomized study, using sodium hyaluronate (HA) injections as the control. Safety and efficacy were evaluated through a one-year (52-week) follow-up period after administration.

To ensure objectivity, the study employed a randomized design, evenly distributing demographic characteristics between the two groups.

The trial achieved a balanced distribution of key factors between the groups, including average patient age (61.3 years for CARTISTEM, 62.2 years for control), osteoarthritis severity indicators like Kellgren–Lawrence Grade, cartilage defect degree (ICRS), and baseline pain scores. This meticulous allocation enhanced the reliability of the clinical outcomes.

A notable aspect of the study design was the inclusion of two primary efficacy endpoints. These simultaneously assessed cartilage regeneration through arthroscopy and patient-reported outcomes (PROs) for pain and functional improvement one year post-CARTISTEM treatment.

The clinical results revealed that CARTISTEM significantly outperformed the control group in both secondary evaluation indicators: improvements in knee pain and function (Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores), and the rate of ICRS Grade 1 or higher improvement (WOMAC p-value

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