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Effect of Autologous Ear Cartilage Micrografting in Knee Osteoarthritis

NCT07755579 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-08-10

No results posted yet for this study

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?

Conditions

  • Osteoarthritis
  • Osteoarthritis (OA) of the Knee
  • Moderate Osteoarthritis

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Orthosera Kft.

    collaborator OTHER

  • Semmelweis University

    collaborator OTHER

  • Regenera Activa Worldwide S.L.

    lead INDUSTRY

Principal Investigators

  • Zsombor Lacza, Dr · Prof. of Sports Science at University of Sports Science, Budapest, Hungary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-22
Primary Completion
2025-12-21
Completion
2027-12-21

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755579 on ClinicalTrials.gov