FibroCell-001

Phase I: The primary objective is to evaluate the safety of intradiscal FibroCell-001 injection in the treatment of lumbar disc degeneration. Secondary objectives are to preliminarily evaluate the efficacy of intradiscal FibroCell-001 injection in the treatment of lumbar disc degeneration, serving as a reference for the clinical dose in subsequent clinical trials; immunogenicity; and changes in inflammatory markers. Phase II: To evaluate the efficacy of intradiscal FibroCell-001 injection in the treatment of lumbar disc degeneration (180 days). Secondary objectives are to evaluate the efficacy of intradiscal FibroCell-001 injection in the treatment of lumbar disc degeneration (follow-up up to 720 days); safety, immunogenicity, and changes in inflammatory markers.