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Announcement of the start of Phase III clinical trials of IK-01 for the treatment of osteoarthritis of the knee

We, CynosBio, are pleased to announce that we have started enrollment of subjects in a Phase III clinical trial for IK-01 (development code), a 3D matrix-type autologous chondrocyte-processed product, for the treatment of osteoarthritis of the knee.IK-01 is a regenerative medicine product that is expected to promote regeneration of autologous chondrocytes, repair damage, and inhibit the progression of osteoarthritis when transplanted into the damaged area of knee cartilage. We have been conducting an open-label, multicenter, exploratory clinical trial (Phase II clinical trial) to evaluate the efficacy and safety of IK-01 for knee osteoarthritis since 2022, and have obtained favorable results in terms of both safety and efficacy so far.