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TOKYO – Fujifilm will apply for authorization as early as this exercise to conduct clinical trials on a stem cell-derived adult tissue therapy, aiming to become the first Japanese company to test cells for practical use in regenerative medicine .
The unit Fujifilm Holdings aims to begin testing therapy for patients suffering from severe complications of leukemia treatment in 2019 and hopes to obtain authorization to manufacture and commercialize the therapy in 2022. The discussions Preliminary discussions with the supervisory agencies are almost complete.
The therapy uses induced pluripotent stem cells, or iPS cells – reprogrammed adult cells to an essentially embryonic state from which they can be used to produce any type of cell of the body. These cells are highly sought after for their promise in the field of regenerative medicine, and companies are working to create businesses around cells, as has been done with drugs and medical devices.
Fujifilm's trials would target dozens of patients with acute graft-versus-host disease, a condition affecting about 40% of bone marrow transplant recipients. The condition can cause inflammation of the skin and liver, as well as diarrhea and vomiting, and occasionally death. There are about 1,000 cases in Japan, including more than 10,000 internationally, including the major Western countries.
The Japanese company aims to exploit the experience of the Australian company Cynata Therapeutics, in which Fujifilm holds a stake. Cynata has ongoing clinical trials in the UK, with 14 of the 15 patients until now fully recovered or showing improvement.
The therapy involves using iPS cells to make mesenchymal stem cells – a variety that can form tissues such as cartilage or fat. Injection of patients with such cells probably suppresses their immune system and prevents the immune cells of the transplanted marrow from attacking their body.
In the future, Fujifilm intends to apply for a trial in the United States and carry them around the world. It would mass produce mesenchymal stem cells made from iPS cells, prepare them as pharmaceuticals and market them to medical and other institutions.
Mesenchymal stem cell transplants are considered effective in treating conditions such as stroke; ulcerative colitis, which can cause severe diarrhea and bloody stools; and critical limb ischemia, possibly resulting from hardened arteries or severe diabetes. Cell transplants are a topic of research in various countries.
Japanese research institutions are conducting trials on iPS-related treatments, although these efforts are more focused on safety testing than on achieving practical use. The government-backed Riken laboratory performs iPS cell transplants for patients with incurable eye disorders, while Osaka University predicts severe heart failure.
In addition to Fujifilm, companies such as Sumitomo Dainippon Pharma and the pharmaceutical group Healios are also considering applying for authorization for clinical trials.
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