Development code: IK‐01

Collagen matrix containing cultured autologous chondrocytes (development code: IK-01) is a product produced from cells collected from the patient’s own cartilage tissue of the knee joint and then seeded and cultured in a collagen gel. This product features the ability to realize a simple surgical procedure by using a collagen matrix having a reasonable strength as a 3D-scaffold. An investigator-initiated trial with IK-01 was conducted in 2012 in subjects with traumatic knee cartilage damage at the Department of Orthopaedic Surgery, Kove University School of Medicine, and at the Foundation for Biomedical Research and Innovation at Kobe (FBRI). We originally entered into a joint development agreement for IK-01 with FBRI in 2015, and a confirmatory trial was started in 2018, mainly at Department of Orthopaedic Surgery, Kove University School of Medicine, and Department of Orthopaedic Surgery, Hirosaki University School of Medicine, and has been completed. In addition, more recently, a clinical study in subjects with knee osteoarthritis has been undertaken.

IK‐01 (Collagen gel matrix)

IK‐01 (Collagen gel matrix)

黒田良祐 先生

Dr. Ryosuke Kuroda

Professor, Department of Orthopaedic Surgery, Kove University Graduate School of Medicine
Chairperson, The Japanese Knee Society (since 2023)
Director, The Japanese Orthopaedic Association (since 2021)
Auditor, Japan Sports Orthopaedic Association (since 2023)
Medical Committee Member, Japan Tennis Association (since 2023)
Team doctor, Orix Buffaloes, Vissel Kobe, Kobelco Kobe Steelers, and other teams

Promoted an investigator-initiated trial (from 2012 to 2016) in collaboration with FBRI to explore the safety and efficacy of the regenerative medicine for knee cartilage using IK-01 transplantation. Also participated as a medical expert in subsequent confirmatory trial and clinical trials in knee osteoarthritis.

石橋恭之先生

Dr. Yasuyuki Ishibashi

Professor, Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine (since 2012)
Chairperson, Japan Sports Orthopaedic Association (since 2023)
Auditor, The Japanese Knee Society (since 2023)
Medical advisor, Kashiwa Reysol

Participated as a coordinating investigator and a principal investigator in a confirmatory trial in traumatic cartilage damage and an exploratory trial in knee osteoarthritis with IK-01.

Treatment strategies for knee cartilage with IK-01

  • (1)

    Chondrocytes are collected from a healthy site of the patient.

  • (2)

    Chondrocytes are cultured using collagen as a scaffold (for 14 days).

  • (3)

    Cultured chondrocytes are shaped tailored to the site of damage.

  • (4)

    A wide area of damage (2 to 9 cm2) can be covered.

  • (5)

    Adhesion with fibrin glue enables an easy surgical procedure.

IK-01による膝軟骨の治療戦略

Status of development

Target disease Stage of development Application Approval
Exploratory trial Confirmatory trial
Traumatic cartilage damage/osteochondritis dissecans     In preparation  
Knee osteoarthritis Ongoing