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RECRUITING
NCT07639424
PHASE4

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

Sponsor: ROKIT Healthcare

View on ClinicalTrials.gov

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.

Official title: A Prospective, Randomized, Multicenter, Open-Label, Assessor-Blinded, Parallel-Group Clinical Trial to Compare the Efficacy and Safety of Microfracture Alone Versus Microfracture Combined With a Cartilage Regeneration Platform in Patients With Knee Cartilage Defects

Key Details

Gender

All

Age Range

19 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2025-12-29

Completion Date

2027-09-30

Last Updated

2026-06-10

Healthy Volunteers

No

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.

Locations (13)

Yeungnam University Medical Center

Daegu, Daegu, South Korea

Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

Bundang Seoul National University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Catholic University of Korea Incheon St. Mary's Hospital

Goyang, Incheon, South Korea

Gachon University Gil Medical Center

Incheon, Incheon, South Korea

Inha University Hospital

Incheon, Incheon, South Korea

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, Seoul, South Korea

Chung-Ang University Hospital

Seoul, Seoul, South Korea

Ewha Womans University Seoul Hospital

Seoul, Seoul, South Korea