Clinical Trial

Effect of Autologous Ear Cartilage Micrografting in Knee Osteoarthritis

Study acronym: EAR2KNEE
Active, Not Recruiting
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Summary
The goal of this clinical trial is to learn if a single injection of autologous cartilage micrografts suspension, obtained through processing with a specialized technology patient's own small piece of ear cartilage, can improve knee osteoarthritis in adult men and women aged 18-75 with confirmed moderate knee osteoarthritis. The main questions it aims to answer are: * Does a single intra-articular injection of autologous ear-cartilage micrografts improve patients' clinical symptoms and knee function over 12 months? * What percentage of patients experience improvement in their complaints following treatment? * Do MRI scans show measurable improvement in knee cartilage condition 6 months after treatment? * Do inflammatory cytokine levels (IL-1β, IL-1α, IL-6, TNF-α) in joint fluid and cartilage tissue correlate with treatment response?
Trial Details
NCT Number NCT07755579
Lead Sponsor Regenera Activa Worldwide S.L.
Collaborators: Orthosera Kft., Semmelweis University
Conditions Osteoarthritis, Osteoarthritis (OA) of the Knee, Moderate Osteoarthritis
Enrollment 33 participants
Start Date 2023-05-22
Primary Completion 2025-12-21 (estimated)
Study Completion 2027-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-08-10