Dinslaken

Researchers are evaluating the safety and effectiveness of mesenchymal stem cells (MSC) derived from umbilical cord tissue (UC-MSC) for treating cartilage damage in the knee joint. This Phase I/IIa clinical trial is a multicenter, single-arm, open-label study involving patients aged 18 to 60 years with symptomatic cartilage defects. The study aims to monitor safety and collect initial data on the treatment's effects over a two-year period after surgery. Eligible patients will receive knee surgery on Day 0, during which the investigational product—10 to 20 million UC-MSC suspended in 1 ml and applied to a collagen carrier (Chondro-Gide®)—will be applied once directly to the cartilage defect. Follow-up visits are scheduled at regular intervals throughout the following 24 months to observe safety and gather efficacy data. Participants will undergo screening to confirm eligibility before treatment. During the study, they will be monitored through clinical assessments and data collection related to any serious adverse events within 24 months after surgery. The study focuses on safety outcomes primarily but also gathers information on treatment effects on the cartilage damage. The total participation duration for each patient is approximately two years post-surgery.