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

24 de julio de 2026 actualizado por: ROKIT Healthcare

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

104

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Corea del Sur
    • Daegu
      • Daegu, Daegu, Corea del Sur, 42415
        • Reclutamiento
        • Yeungnam University Medical Center
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Corea del Sur, 14647
        • Reclutamiento
        • Catholic University of Korea Bucheon St. Mary's Hospital
      • Guri-si, Gyeonggi-do, Corea del Sur, 11923
        • Reclutamiento
        • Hanyang University Guri Hospital
      • Gwangmyeong, Gyeonggi-do, Corea del Sur, 14220
        • Reclutamiento
        • Chung-Ang University Gwangmyeong Hospital
      • Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
        • Reclutamiento
        • Bundang Seoul National University Hospital
    • Incheon
      • Goyang, Incheon, Corea del Sur, 21431
        • Aún no reclutando
        • Catholic University of Korea Incheon St. Mary's Hospital
      • Incheon, Incheon, Corea del Sur, 21565
        • Reclutamiento
        • Gachon University Gil Medical Center
      • Incheon, Incheon, Corea del Sur, 22332
        • Reclutamiento
        • Inha University Hospital
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Corea del Sur, 54907
        • Reclutamiento
        • Jeonbuk National University Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Corea del Sur, 58128
        • Reclutamiento
        • Chonnam National University Hwasun Hospital
    • Seoul
      • Seoul, Seoul, Corea del Sur, 5278
        • Reclutamiento
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Seoul, Corea del Sur, 6973
        • Reclutamiento
        • Chung-Ang University Hospital
      • Seoul, Seoul, Corea del Sur, 7804
        • Aún no reclutando
        • Ewha Womans University Seoul Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control
only Microfracture on Knee cartilage defect site
Procedimiento: 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
Procedimiento: 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.
Otros nombres:
  • Dr.INVIVO
  • AID REGEN
  • AI REGEN

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change from baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 1year
Periodo de tiempo: Baseline to 12 months
Baseline to 12 months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score, assessed at 3, 6, and 9 months
Periodo de tiempo: Baseline, 3 months, 6 months, 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
Periodo de tiempo: Baseline, 6 months, 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
Periodo de tiempo: Baseline, 3 months, 6 months, 9 months, 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
Periodo de tiempo: Change from baseline in IKDC
Change from baseline in IKDC

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

ROKIT Healthcare

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de diciembre de 2025

Finalización primaria (Estimado)

30 de junio de 2027

Finalización del estudio (Estimado)

30 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

5 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • B-2511-1011-003

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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