New cartilage regeneration treatment added to microfracture for knee cartilage defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional trial compares microfracture alone to microfracture plus a new MAECM transplantation-based cartilage regeneration treatment in adults with focal knee cartilage defects. Participants will undergo standard surgery, then receive follow-up imaging and clinical assessments to monitor knee motion, pain, and cartilage quality over time. The study aims to determine if the combined approach provides superior functional outcomes and safety, relative to standard care. Imaging, including MRI, will be used to evaluate regeneration of new cartilage and structural integrity. Enrollment targets adults aged 19 to under 65 with specific lesion sizes and ICRS grades, at multiple Korean centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yeungnam University Medical Center
  Daegu, Daegu, South Korea Recruiting
• Catholic University of Korea Bucheon St. Mary's Hospital
  Bucheon-si, Gyeonggi-do, South Korea Recruiting
• Hanyang University Guri Hospital
  Guri-si, Gyeonggi-do, South Korea Recruiting
• Chung-Ang University Gwangmyeong Hospital
  Gwangmyeong, Gyeonggi-do, South Korea Recruiting
• Bundang Seoul National University Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• Gachon University Gil Medical Center
  Incheon, Incheon, South Korea Recruiting

Study contacts

• Study coordinator: Geunpyung Jung
• Email: geunpyung.jung@rokit.co.kr
• Phone: +821084840182

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.