Phase 12a Study Testing Safety and Effectiveness of Umbilical Cord Tissue-Derived MSCs for Knee Cartilage Damage Treatment

What this Trial Is About

Researchers are evaluating the safety and initial effectiveness of mesenchymal stromal cells MSCs derived from umbilical cord tissue to treat cartilage damage in the knee joint. This prospective, multicenter, single-arm, open-label clinical trial focuses on patients with symptomatic cartilage defects who are candidates for surgical cartilage regeneration. The study aims to provide detailed safety data and early efficacy outcomes over a two-year period following treatment. Eligible patients will undergo arthroscopic or minimally invasive knee surgery during which the investigational product, called MesemCart, containing 10 to 20 million UC-MSCs applied to a collagen carrier, will be placed once directly on the cartilage defect. All participants receive this same treatment and are followed up regularly for 24 months. The study includes a single treatment arm without any placebo or comparison groups. Participants will be monitored through scheduled visits up to two years after surgery to assess safety, including serious adverse events, and to evaluate cartilage regeneration using imaging scores and patient-reported outcomes. These outcomes include pain levels, knee-related quality of life, symptoms, stiffness, activities of daily living, and physical resilience during sports, measured at 12 and 24 months. Safety will be tracked continuously, with all adverse events documented and assessed throughout the study.

Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint