Fujifilm and Tokyo Medical and Dental University conclude the patent licensing agreement on the world's first autologous mesenchymal stem cell transplantation technology targeting meniscus injury

- Accelerating measures towards early commercialization of meniscal conservative treatment using regenerative medicine

March 05, 2019
FUJIFILM Corporation
Tokyo Medical and Dental University

FUJIFILM Corporation (President: Kenji Sukeno; hereinafter “Fujifilm”) and Tokyo Medical and Dental University, a national university corporation (President: Yasuyuki Yoshizawa; hereinafter “TMDU”), concluded today a patent licensing agreement on a technology to transplant autologous mesenchymal stem cells* targeting meniscus injury. The technology uses an arthroscope that enables surgery with minimal invasion to administer, to meniscus injury patients, cell suspensions that use synovium-derived** autologous mesenchymal stem cells (hereinafter “synovial membrane stem cells”). The technology was developed, for the first time in the world, by Professor Ichiro Sekiya, director of the Center for Stem Cell and Regenerative Medicine at TMDU. It is expected to make preservation of the meniscus possible while alleviating the patients' physical burden during treatment.
Based on this agreement, Fujifilm will obtain from TMDU the exclusive right to develop, manufacture and commercialize, throughout the world, regenerative medical products that make use of synovial membrane stem cells, created through this technology. TMDU, in turn, will receive an upfront payment, development milestone payments, and royalty on sales from Fujifilm.

The meniscus is a crescent-shaped piece of cartilage found inside the knee. It acts as a cushion to reduce the burden on the knees. Meniscus injuries occur when the meniscus snaps apart and tears as a result of a strong impact, aging and other factors during sports and daily living. The current recommended treatment of a meniscus injury is a meniscus suture*** that can preserve the meniscus. In addition, since an arthroscope is used, a meniscus suture has low invasiveness. However, the sites and condition of the tear to which this technique can be applied are limited. If the technique cannot be applied, meniscus removal*4 or conservative therapy is employed. These techniques, however, have issues in certain cases. With meniscus removal, because the meniscus is resected, the cartilage of the knees becomes worn out through friction, increasing the risk of causing osteoarthritis of the knee*5. In particular, patients in their 40s and older, for whom meniscus removal is often employed, are called high-risk groups for developing osteoarthritis of the knee. On the other hand, conservative therapy is a symptomatic treatment that uses analgesics and other drugs, and cannot expect to produce therapeutic effects. Given this situation, there is now an increasing need for new treatment methods.

The patent licensing agreement which Fujifilm and TMDU have concluded on this occasion pertains to a technology to transplant synovial membrane stem cells into the part of the meniscus that has become torn. The technology combines a low-invasive surgery using arthroscopes, and cell transplantation, and is an innovative technique targeting patients for whom a meniscus suture is not employed, that can expect to see symptoms improve while preserving the meniscus. In the treatment using this technology, arthroscope is first employed to suture the part that had become torn and adjust the shape of the meniscus. At the same time, some synovial membrane inside the knee joints is extracted. Later, synovial membrane stem cells that have been isolated from the synovial membrane are cultured for approximately two weeks to prepare a cell suspension, which is then administered to the part of the meniscus that has become torn (see diagram below). The synovial membrane stem cells in the cell suspension are engrafted onto the meniscus and speed up the repair process. By so doing, they work to improve clinical symptoms such as pain, jerkiness and instability felt when bending and stretching the knees, and when standing up. Preserving the meniscus, moreover, can be expected to suppress the onset of osteoarthritis of the knee.
Going forward, in addition to this technology, Fujifilm will make use of the engineering technologies it has fostered and evolved through a wide range of products, as well as the technologies and expertise related to cell culture and quality control owned by Japan Tissue Engineering Co.,Ltd. (hereinafter “J-TEC”), its subsidiary that launched Japan's first-ever regenerative medical products onto the market, to promote the practical application of regenerative medical products using synovial membrane stem cells targeting meniscus injury.

[Figure]Treatment method using synovial stem cell transplantation

Since 2015, TMDU has been carrying out joint research with Fujifilm on meniscus injury using transplantation technology employing synovial stem cells, as part of the R&D project*6 of the Japan Agency for Medical Research and Development (AMED), under an industry-academia collaboration setup. Since 2017, moreover, it has been carrying out investigator-initiated clinical trials*7 on regenerative medical products that use this technology. J-TEC has been commissioned to manufacture investigational products being used for this trial.

Fujifilm will collaborate with J-TEC and other group companies, make use of its broad-ranging technologies to accelerate the R&D of regenerative medical products, and contribute to industrializing regenerative medicine as quickly as possible.
TMDU, as the only comprehensive medical graduate school and university in Japan engaged in the practice of innovative medicine through the fusion of medicine and dentistry, will create “the artistry of knowledge and healing,” and contribute to enhancing people's health and social welfare.

Reference data
The number of meniscus-only surgeries by age in Japan (Source: 2016 NDB Open Data)

[Figure]Reference data

  • * Mesenchymal stem cells extracted from the patients' tissues. They are a type of stem cells that exist in vivo, and have certain differentiation and proliferation capabilities. Clinical studies are being carried out with over 1,000 subjects to examine their use in the treatment of a variety of diseases including cerebral infarction, cartilage damage, ischemic heart failure, and lower limb ischemia. They are expected to demonstrate diverse effects, and, at the same time, are verified to have a high level of safety.
  • ** A synovial membrane is a membrane that wraps the joints. By secreting joint fluid, it helps move the joints smoothly and provides nutrition to the part of the joint called articular cartilages.
  • *** This is a surgical method that sutures together damaged meniscus pieces. The operation is performed using an arthroscope.
  • *4 This is a surgical method that resects a damaged meniscus either partially or wholly. The operation is performed using an arthroscope.
  • *5 A disease characterized by the wear of articular cartilage. It is estimated that 25 million people have this disease in Japan, including potential patients. If a patient develops osteoarthritis of the knee, he/she cannot hope to recover completely with treatment alone. At present, the only treatment methods available for them include symptomatic treatment to alleviate pain, as well as osteotomy and artificial joint replacement.
  • *6 Name of research project: “Regenerative Medicine Commercialization Research Project.”
  • *7 A clinical trial in which a physician himself/herself draws up a protocol, and carries out/supervises all operations, from implementation of a clinical trial to compilation of the findings.

For inquiries on information in this media release, contact:

Media Contact:
Corporate Communications Division, FUJIFILM Corporation
TEL :+81-3-6271-2000
Public Relations Office, TMDU
TEL :+81-3-5803-5833
Email :kouhou.adm@tmd.ac.jp
Inquiries related to the license agreement:
Regenerative Medicine Department, FUJIFILM Corporation
TEL :+81-3-6271-3030
Inquiries related to treatment methods:
Ichiro Sekiya, Center for Stem Cell and Regenerative Medicine, TMDU
TEL :+81-3-5803-4017