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Effect of Autologous Ear Cartilage Micrografting in Knee Osteoarthritis
Sponsor: Regenera Activa Worldwide S.L.
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?
Official title: Effect of Autologous Cartilage Micrografting in Knee Cartilage Disease
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2023-05-22
Completion Date
2027-12-21
Last Updated
2026-08-10
Healthy Volunteers
No
Interventions
Mytocel MSK - Autologous Ear Cartilage Micrografting
Autologous Ear Cartilage micrografting using Rigenera Technology - Mytocel MSK. A 2.5 mm punch biopsy of the patient's own auricular ear cartilage is harvested under local anesthesia. The tissue is mechanically disaggregated within the device after addition of 4mL sterile physiological saline, yielding a micrograft suspension containing autologous cartilage progenitor cells - without cell culture, expansion, or enzymatic digestion. The micrograft suspension is then delivered as a single intra-articular injection. The procedure is performed once per patient, on one knee, in a single outpatient session lasting approximately 30 minutes.
Locations (1)
Semmelweis University
Budapest, Hungary