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

NCT07639424 | Recruiting Phase 4

• 1 other identifier: B-2511-1011-003
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 13

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 1year

  Baseline to 12 months

Secondary Outcomes (4)

• Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score, assessed at 3, 6, and 9 months

  Baseline, 3 months, 6 months, and 9 months

• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score assessed by an independent evaluator at 6 and 12 months

  Baseline, 6 months, and 12 months

• Change from baseline in 100-mm Visual Analog Scale (VAS) pain score at 3, 6, 9, and 12 months

  Baseline, 3 months, 6 months, 9 months, and 12 months

• Change from baseline in International Knee Documentation Committee (IKDC) score at 3, 6, 9, and 12 months

  Change from baseline in IKDC

Study Arms (2)

Control

ACTIVE COMPARATOR

only Microfracture on Knee cartilage defect site

Procedure: Micronfracture

Test

EXPERIMENTAL

Microfracture with Micronized Auotologous ExtraCellular Matrix

Procedure: MAECM transplantation

Interventions

Micronfracture PROCEDURE

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.

Control

MAECM transplantation PROCEDURE

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.

Also known as: Dr.INVIVO, AID REGEN, AI REGEN

Test

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 19 years to \<65 years at the time of consent.
• Cartilage lesion severity of the target knee is ICRS grade 3 or 4.
• Focal cartilage defect size in the target knee is ≥5 cm² and ≤10 cm².
• The target knee is clinically considered to require microfracture, or microfracture with high tibial osteotomy (HTO).
• Able and willing to provide written informed consent after receiving a full explanation of the study.

You may not qualify if:

• Traumatic or secondary osteoarthritis (Secondary OA) in the target knee.
• Inflammatory arthritis in the target knee (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, gout, pseudogout, Behçet's disease, etc.).
• Currently receiving immunosuppressive therapy or having a serious systemic disease (e.g., severe cardiovascular disease; long-term use of immunosuppressants; cancer patient receiving chemotherapy; systemic autoimmune disease; severe liver or kidney disease; uncontrolled endocrine disease, etc.).
• Advanced severe osteoarthritis in the target knee (Kellgren-Lawrence \[KL\] grade 4).
• Lower-limb malalignment that may affect the surgical plan (e.g., varus deformity with varus angle ≥15°).
• Within 5 years prior to Visit 1, a history of osteomyelitis of the target knee, a diagnosis of malignancy, or recurrent malignancy (participants with benign tumors may be eligible if the investigator judges that there will be no impact on study conduct during the study period).
• Body mass index (BMI) ≥35 kg/m².
• Clinically significant knee instability in the target knee that is not expected to be improved by the study procedure (e.g., complete or partial tears of major ligaments such as the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament).
• Prior surgery for treatment of a cartilage defect in the target knee (diagnostic arthroscopy only is allowed).
• History of major structural surgery of the target knee (diagnostic arthroscopy only is allowed). Participants with prior HTO may be eligible at the investigator's discretion if the knee structure is stable without critical defects.
• Intra-articular injection of any biologic or pharmacologic agent into the target knee within 3 months prior to Visit 1 (e.g., hyaluronic acid, corticosteroids, platelet-rich plasma, autologous cell therapy, cytokine inhibitors, etc.).
• Use of systemic corticosteroids within 1 month prior to Visit 1.
• Participant or partner is a woman of childbearing potential and the participant does not agree to use an effective method of contraception during the study period, including any of the following:
• Sterilization procedure of the participant or partner (vasectomy; bilateral oophorectomy and salpingectomy/tubal ligation; hysterectomy)
• Intrauterine device (IUD), including copper IUD or hormone-releasing intrauterine system

Sponsors & Collaborators

• ROKIT Healthcare: lead

Study Sites (13)

Yeungnam University Medical Center

Daegu, Daegu, 42415, South Korea

RECRUITING

Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

RECRUITING

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, 14220, South Korea

RECRUITING

Bundang Seoul National University Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Catholic University of Korea Incheon St. Mary's Hospital

Goyang, Incheon, 21431, South Korea

NOT YET RECRUITING

Gachon University Gil Medical Center

Incheon, Incheon, 21565, South Korea

RECRUITING

Inha University Hospital

Incheon, Incheon, 22332, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

RECRUITING

Kyung Hee University Hospital at Gangdong

Seoul, Seoul, 5278, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, Seoul, 6973, South Korea

RECRUITING

Ewha Womans University Seoul Hospital

Seoul, Seoul, 7804, South Korea

NOT YET RECRUITING

Central Study Contacts

Geunpyung Jung

CONTACT

+821084840182; geunpyung.jung@rokit.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

KR (13)