DEVELOPMENT
DEVELOPMENT
R&D
Cellular Products by Cyfuse
The development pipeline (line-up of developed products) at Cyfuse originates from needs in the medical setting that come from doctors and researchers working in the medical field.
“Bio 3D Printing,” the platform technology of Cyfuse, has garnered appreciable attention in the field of regenerative medicine in Japan and abroad, having been extensively published in articles in Japan and elsewhere, and featured in presentations and lectures at major academic conferences, for example.
“3D Cellular Products,” which are tissues and organs fabricated entirely from nothing but cells by the Bio 3D Printer, have thickness and elasticity closely approximating that of actual tissues and organs, have functions approximating those of the living body, and also enable surgical treatments. No three-dimensional regenerative medical product produced solely from cells is available in current state-of-the-art medical practice. The creation of new treatment options such as the 3D cellular products by Cyfuse will help to build new markets.
Regenerative Medicine
Osteochondral Regeneration
Articular cartilage has a very poor self-regenerating capacity because it is devoid of any vasculature; once cartilage is damaged, injuries tend to progress due to the lack of self-regeneration. The only damage repaired by conventional cartilage products is the thin cartilage layer on the surface of the joint. Therefore, if the damage extends to the subchondral bone layer supporting the cartilage layer, the only available option is symptomatic therapy, which involves replacement with an artificial joint or follow-up.
The cell-based osteochondral structure currently under clinical development by Cyfuse is grafted to a defect. It has been shown that after grafting, the cells themselves gradually differentiate into cartilage and bone, and simultaneously regenerate the various tissues of the subchondral bone supporting the cartilage and cartilage layer, thus showing considerable promise for improving the QOL (quality of life) of patients for whom effective treatment has been thus far unavailable.
Regenerative Medicine
Revascularization
Cyfuse is working on the development of new treatment options for minimizing the risk and toll of infections, for which “small-diameter cell-based blood vessels” are transplanted as alternatives to artificial blood vessels in patients who require blood transfusions due to renal failure, for example.
The results of research on cell-based vascular structures currently under joint clinical development by Cyfuse and Saga University Hospital, with the support of AMED, have been published in Nature Communications, etc., and indicate that these types of infection-resistant and highly elastic cell-based blood vessels show considerable promise as new treatment options for dialysis patients with vascular disorders, including diabetes.
Regenerative Medicine
Nerve Regeneration
Cyfuse is working on the development of a new treatment option for regenerating torn nerves for sensory nerve and motor nerve enhancement, wherein “cell-based nerve conduits” are grafted in patients needing limb function recovery from peripheral nerve damage, for example.
The results of research on cell-based neural structures (nerve conduits) currently under joint clinical development by Cyfuse and Kyoto University Hospital, with the support of AMED, have been published in Scientific Report, Cell Transplants, Microsurgery, etc., as well as in the electronic US academic journal PLOS ONE and the US science journal Newton; they indicate that these structures show considerable promise as new treatment options for promoting the regeneration of native nerves without sacrificing native healthy tissue in people with torn nerves from accidents or tumor resection and those for whom autologous nerve grafts are not feasible.
Drug Discovery Support
Liver Structures
Current evaluation of the hepatotoxicity and metabolites of new drug candidate compounds under pharmaceutical development is based on evaluation test systems using (primarily) mice, and in vitro evaluation systems using primary cultured human hepatocytes. However, a major drawback is that functionality is lost in only a few days.
When a new drug candidate compound (drug) is added to a cultured medium of 3D liver structures created solely from human hepatocytes, currently under development by Cyfuse, the drug is taken up through the medium and metabolized by enzymes in the hepatocytes, allowing the hepatotoxicity of the drug to be estimated on the basis of the metabolites. The use of these 3D liver structures in safety studies, etc., in the preclinical stage may enable early detection of human-specific hepatotoxicities, which have been difficult to detect in the animal studies used thus far and in existing in vitro evaluation systems, and may make it possible to predict adverse events (associated with candidate drugs) that can potentially occur in the human liver. 3D liver structures hence show considerable promise as a new evaluation model with long-lasting hepatic function.
DEVELOPMENT