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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Imminent Announcement of 12-Month MRI Results from OSCA Phase I Clinical Trial
11
2025.04
The clinical trial of the osteoarthritis treatment drug “OSCA” has entered the final stages of the 12-month MRI evaluation, which includes the high-dose group in Phase 1.
The clinical trial of the osteoarthritis treatment drug “OSCA” has entered the final stages of the 12-month MRI evaluation, which includes the high-dose group in Phase 1. This evaluation is being independently conducted by RadMD, a U.S.-based radiology expert evaluation company with extensive experience working with the FDA. In addition, further evaluations by domestic radiology specialists are being carried out to enhance the objectivity and reliability of the data.
Yo-han Bae, Head of Clinical Development at Kangstem Biotech, stated, “We have currently received the 12-month MRI evaluation data for the high-dose group from RadMD, and we are in the process of comparing and analyzing the MOCART and WORMS results at the baseline and 6-month time points to assess improvements in the most damaged areas of the knee joint and the overall structural evaluation of the knee joint. Once data analysis is complete, additional evaluations of MRI images, including cartilage regeneration, will be conducted by domestic radiology experts." He added, "In the global market, there is a trend to require at least 12 months of data on symptoms, function, and structural improvement to confirm the fundamental therapeutic effect. Therefore, the 12-month data from this Phase 1 trial will be a key piece of evidence that can help OSCA be recognized as a potential fundamental treatment for osteoarthritis in the global market.”
Meanwhile, the 6-month MRI evaluation showed that, in MOCART, most patients demonstrated improvement or no progression of damage (7 out of 10 showed improvement, 1 showed no change). In WORMS, structural improvements were observed through regeneration of cartilage, subchondral bone, cysts, and synovitis
(inflammation of the synovial membrane). Additionally, the low-dose and mid-dose groups showed a tendency for the effects at the 6-month mark to be maintained or further improved based on the 12-month data.
※OSCA: The name “OSCA” is a combination of Kangstem Biotech's stem cell international nonproprietary name ‘OSiramestrocel’ and cartilage acellular matrix ‘CAM’ It is the technical platform brand name for the stem cell combination product, Furestem-OA Kit.