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Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair
Sponsor: ROKIT Healthcare
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
Conditions
Interventions
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.
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