Fujifilm Announces the Start of a New Phase III Clinical Trial in Japan Targeting Patients with Meniscus Injuries

TOKYO, February 14, 2023 – FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) announces the start of a new Phase III clinical trial in Japan for its stem cell therapy candidate “FF-31501” (development code) based on autologous synovial mesenchymal stem cells (MSCs)^*1. The Phase III clinical trial^*2 targets patients with meniscus injuries indicated for meniscectomy.

As part of the trial, FF-31501 effects on restoration of meniscus function and structure in addition to reduction of knee symptoms and pain will be verified 52 weeks after transplantation, using the Lysholm Knee Scoring system^*3 as a primary endpoint, as well as MRI and arthroscopic image diagnosis as secondary endpoints. The clinical trial is already underway on the first patient at the Tokyo Medical and Dental University Hospital. The target enrollment is 18 patients.

FF-31501 involves arthroscopic treatment with suspension of autologous synovial MSCs, a cell transplantation technology developed by Professor Ichiro Sekiya, the director of the Center for Stem Cell and Regenerative Medicine, Tokyo Medical and Dental University (TMDU). It is expected to preserve the injured meniscus by the implanted MSCs promoting injury healing, possibly resulting in reduced risk of developing osteoarthritis of the knee. 

TMDU and Fujifilm conducted the joint research on the stem cell therapy based on the technology developed by Professor Ichiro Sekiya targeting meniscus injuries granted by the Japan Agency for Medical Research and Development (AMED)^*5. In addition, a feasibility clinical trial^*6 targeting meniscus injuries for meniscectomy was performed at TMDU under AMED’s support^*7, suggesting the promising results in the Lysholm Knee Scoring system as the primary endpoint. Fujifilm obtained the exclusive worldwide license from TMDU for development, manufacture, and sales for the stem cell therapy based on this technology in 2019.

• *1 Mesenchymal stem cells produced by a patient’s own synovium; MSCs are multipotent progenitor cells with high proliferation and multilineage differentiation potential and immune-modulatory properties.
• *2 FUJIFILM Corporation commissions FUJIFILM Toyama Chemical Co., Ltd., to conduct the clinical trial and the Foundation for Biomedical Research and Innovation at Kobe to manufacture investigational products used in the trial.
• *3 Representative evaluation of knee functions and symptoms such as pain, instability, and locking.
• *4 Osteoarthritis, a major type of degenerative joint disease involving progressive cartilage degradation, affects more than 20 million patients in Japan. 
• *5 “Development of MSC-based regenerative medical therapy for osteoarthritis of the knee (cartilage, meniscus),” set by AMED in their regenerative medicine application research project (Support period: FY2015-FY2017)
• *6 [Feasibility clinical trial] (UMIN000026383)
• *7 “Investigator-led clinical testing for the use of autologous MSCs on torn meniscus,” set by AMED in their regenerative medicine application project (Support period: FY2018-FY2019)

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