Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu, “Sysmex”), HEALIOS K.K. (HQ: Minato-ku, Tokyo, Japan; President and CEO: Hardy TS Kagimoto, “Healios”) and Sumitomo Dainippon Pharma Co., Ltd. (HQ: Osaka, Japan; President and CEO: Masayo Tada, “Sumitomo Dainippon Pharma”) hereby provide notice that the three companies have begun pursuing joint research and development toward the establishment of a pre-transplant immune reaction testing method for retinal pigment epithelial cells (RPE cells) derived from allogeneic induced pluripotent stem (iPS) cells.
iPS cell1 transplantation therapy is divided into two methods: autologous transplantation, where cells produced from iPS cells derived from a patient’s own body, and allogeneic transplantation, which uses cells produced from iPS cells derived from a donor who meets certain criteria (allogeneic iPS cells). Autologous transplantation already has a track record of use in therapy, but involves a number of issues. This method requires producing iPS cells from a patient’s own cells and then inducing cellular differentiation2 suitable for transplantation therapy. Producing cells for transplant requires time and the production costs are substantial.
The method of allogeneic transplantation, on the other hand, may have the potential to provide cells with assured quality for transplantation therapy timely, stably and inexpensively, because allogeneic iPS cells are stored and managed in cell banks3, and cells for transplant are produced systematically in standardized processes. However, since allogenic transplantation, —the treatment method using cells derived from allogeneic iPS cells— may induce post-transplant immunorejection4, it is necessary to develop a new testing method to confirm prior to transplantation whether cells are suitable for transplant, including the possibility to cause immunorejection.
To this end, Sysmex, Healios and Sumitomo Dainippon Pharma have commenced joint R&D on pre-transplant immune reaction testing for a regenerative medicine containing RPE cells5 derived from allogeneic iPS cells, which is jointly developed in Japan by Healios and Sumitomo Dainippon Pharma, targeting age-related macular degeneration6 and other ocular diseases.
Healios and Sumitomo Dainippon Pharma will provide Sysmex with RPE cells they have produced from allogeneic iPS cells, and Sysmex will use its proprietary imaging flow cytometers and protein analysis technology to develop a pre-transplant immune reaction testing method. It is anticipated that testing results can be reflected in immunosuppressive therapy such as optimizing immunosuppressive agent administration frequency and dosages for patients following allogeneic cell transplantation.
Sysmex, Healios and Sumitomo Dainippon Pharma will work together on technological developments to further enhance the quality and efficiency of healthcare and pursue R&D toward the commercialization of leading-edge technologies.
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