Effect of Autologous Ear Cartilage Micrografting in Knee Osteoarthritis

NCT07755579 | Active Not Recruiting

• 4 other identifiers: MYTOCEL-KNEE-OA-052023Official Research Registrationref. BM/1298-3/2024OGYÉI/67359-9/2023
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

ear to knee; mytocel; mytocel msk; autologous micrografting; osteoarthritis; rigenera technology

Outcome Measures

Primary Outcomes (1)

• Change in Knee Osteoarthritis Outcome Score (KOOS)

  Change from baseline in KOOS subscale scores (including Pain and Symptoms/Stiffness), scored 0-100 with higher scores indicating better knee-related quality of life and function. Assessed via repeated-measures analysis across follow-up visits relative to baseline

  Baseline, 1 week, 3 months, 6 months, 12 months, and 24 months

Secondary Outcomes (2)

• Change in knee cartilage thickness on MRI

  Baseline, 6 months

• Baseline synovial fluid and cartilage tissue cytokine concentrations

  Time of the procedure

Study Arms (1)

Intervention Group

OTHER

Autologous Cartilage Micrografting is performed to all subjects with moderate knee osteoarthritis

Device: Mytocel MSK - Autologous Ear Cartilage Micrografting

Interventions

Mytocel MSK - Autologous Ear Cartilage Micrografting DEVICE

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.

Also known as: Mytocel MSK, Autologous Micrografting, Rigenera Technology

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed knee OA L-K grade II-III
• Symptomatic knee OA (with pain)
• Reduced mobility

You may not qualify if:

• Knee OA L-K grade IV
• Systemic Joint Disease (e.g. rheumatoid arthritis)
• Active autoimmune disease
• Active Oncologic process
• If other orthobiologic treatments administered in the last 3 months

Sponsors & Collaborators

• Regenera Activa Worldwide S.L.: lead
• Orthosera Kft.: collaborator
• Semmelweis University: collaborator

Study Sites (1)

Semmelweis University

Budapest, 1085, Hungary

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Zsombor Lacza, Dr

  Prof. of Sports Science at University of Sports Science, Budapest, Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A disposable medical device used in regenerative medicine based treatment protocols

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: May 22, 2023
• Primary Completion: December 21, 2025
• Study Completion (Estimated): December 21, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

HU (1)