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UnicoCell Seeks US FDA Protocol Amendment for Phase 3 Knee Osteoarthritis Trial
UnicoCell Biomed (TPE:6794) has applied to the U.S. Food and Drug Administration (FDA) to amend the Phase three clinical trial protocol for its adipose-derived stem cell therapy ELIXCYTE-OA, for the treatment of knee osteoarthritis.The company said it originally submitted the Phase three trial to the FDA on Sept. 13, 2022, and is seeking the amendment to support subsequent verification and registration processes.UnicoCell did not disclose the accumulated R&D spending, citing licensing negotiations, and said the timeline for completing the trial will depend on the project's progress.
TPE:6794
