Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair (TCW)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cartilage Defects of the Knee
• Intervention / Treatment: Procedure: Micronfracture; Procedure: MAECM transplantation

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Geunpyung Jung; Phone Number: +821072423752; Email: geunpyung.jung@rokit.co.kr

Study Locations

• South Korea
  • Daegu
    • Daegu, Daegu, South Korea, 42415
      • Recruiting
      • Yeungnam University Medical Center
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea, 14647
      • Recruiting
      • Catholic University of Korea Bucheon St. Mary's Hospital
    • Guri-si, Gyeonggi-do, South Korea, 11923
      • Recruiting
      • Hanyang University Guri Hospital
    • Gwangmyeong, Gyeonggi-do, South Korea, 14220
      • Recruiting
      • Chung-Ang University Gwangmyeong Hospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Bundang Seoul National University Hospital
  • Incheon
    • Goyang, Incheon, South Korea, 21431
      • Not yet recruiting
      • Catholic University of Korea Incheon St. Mary's Hospital
    • Incheon, Incheon, South Korea, 21565
      • Recruiting
      • Gachon University Gil Medical Center
    • Incheon, Incheon, South Korea, 22332
      • Recruiting
      • Inha University Hospital
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, South Korea, 54907
      • Recruiting
      • Jeonbuk National University Hospital
  • Jeollanam-do
    • Hwasun, Jeollanam-do, South Korea, 58128
      • Recruiting
      • Chonnam National University Hwasun Hospital
  • Seoul
    • Seoul, Seoul, South Korea, 5278
      • Recruiting
      • Kyung Hee University Hospital at Gangdong
    • Seoul, Seoul, South Korea, 6973
      • Recruiting
      • Chung-Ang University Hospital
    • Seoul, Seoul, South Korea, 7804
      • Not yet recruiting
      • Ewha Womans University Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

  1. Sterilization procedure of the participant or partner (vasectomy; bilateral oophorectomy and salpingectomy/tubal ligation; hysterectomy)
  2. Intrauterine device (IUD), including copper IUD or hormone-releasing intrauterine system
  3. Non-oral hormonal contraception or spermicide used in combination with a barrier method
  4. Cervical cap or diaphragm used in combination with a male condom
• Pregnant or breastfeeding.
• Participation in another clinical trial and receipt of an investigational medical device within 6 months prior to Visit 1.
• Any other condition that, in the opinion of the principal investigator (or delegated study staff), makes the participant unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; only Microfracture on Knee cartilage defect site	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.
Experimental: Test; Microfracture with Micronized Auotologous ExtraCellular Matrix	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.; Other Names: Dr.INVIVO; AID REGEN; AI REGEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline KOOS total score at 1year	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in KOOS total score, assessed at 3, 6, and 9 months	Baseline, 3 months, 6 months, and 9 months
MOCART score assessed by an independent evaluator at 6 and 12 months	Baseline, 6 months, and 12 months
Change from baseline in 100-mm VAS pain score at 3, 6, 9, and 12 months	Baseline, 3 months, 6 months, 9 months, and 12 months
Change from baseline in IKDC score at 3, 6, 9, and 12 months	Change from baseline in IKDC

Collaborators and Investigators

• Sponsor: ROKIT Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: B-2511-1011-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No