Nature Cell Keeps Hopes Up For JointStem Despite Conditional Approval Rejection

Nature Cell remains positive on its degenerative osteoarthritis therapy JointStem as it seeks to move on to a Phase III study in South Korea, and reattempts to seek conditional approval after its initial such filing based on Phase II results was rejected earlier this year.

Render illustration of Clinical Trial title on medical documents — NATURE CELL SEEKS PHASE III APPROVAL FOR CELL THERAPY

South Korea's Biostar Stem Cell Research Institute, which is jointly operated by Nature Cell Co. Ltd. and sister firm R Bio, has filed an IND to begin a domestic Phase III study for JointStem, its stem cell therapy for degenerative osteoarthritis (OA), after national regulatory authorities rejected an earlier filing seeking conditional approval of the therapy.

Nature Cell recently filed an objection to the Central Pharmaceutical Affairs Council's decision and is seeking the conditional approval again,...