NatureCell, JointStem Receive US FDA Approval for Phase 2b and 3a Clinical Trial Plans
[Asia Economy Reporter Eunmo Koo] Naturecell announced on the 20th that it has received approval from the U.S. Food and Drug Administration (FDA) for the Phase 2b/3a clinical trial plan of JointStem, a stem cell treatment for severe degenerative arthritis.
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The company stated, "It is classified as an autologous cell therapy that harvests and isolates adult stem cells from one's own adipose tissue, then activates and proliferates them through culture without additional genetic modification or physical and chemical changes, so no separate immune rejection occurs." They added, "With a single direct local injection into the knee joint cavity without surgery, it is expected to reduce knee pain and improve joint function, minimizing patients' resistance and increasing satisfaction in terms of ease of use."
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