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Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair

NCT07639424 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-07-28

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are:

Does the treatment help the knee work better and lower pain more than the standard surgery?

Is the treatment safe and does it help grow stronger new cartilage?

Researchers will compare participants who get the standard surgery (microfracture) to participants who get both the standard surgery and the new treatment. This is to see if the new treatment leads to a better and faster recovery.

Participants will:

Have a surgery to treat their knee cartilage damage.

Visit the clinic for check-ups to see how well their knee moves.

Take imaging tests, like an MRI, so researchers can look at the new cartilage.

Conditions

  • Cartilage Defects of the Knee

Interventions

PROCEDURE

MAECM transplantation

This intervention is a multi-step, autologous tissue-based regenerative procedure. Arthroscopic debridement is first performed at the focal cartilage defect. Microfracture is then performed at the defect bed according to standard technique. Infrapatellar fat pad (IFP) tissue is subsequently harvested through a small incision. The harvested autologous tissue is processed intra-operatively to generate micronized autologous ECM and prepared as a printable formulation. A patient-specific patch is fabricated using a 3D bioprinting system and implanted to cover the focal cartilage defect. The study evaluates patch integration and regenerative outcomes following implantation.

PROCEDURE

Micronfracture

This intervention consists of arthroscopic debridement of the focal cartilage defect followed by microfracture performed at the defect bed according to standard technique. The study evaluates clinical and structural outcomes following microfracture.

Sponsors & Collaborators

  • ROKIT Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-29
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • South Korea

Study Locations

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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 NCT07639424 on ClinicalTrials.gov