The my iPS Project aims to realize regenerative medicine using autologous iPS cells, which are generated from a patient’s own cells.
When regenerative therapies using iPS cells become widely available in the future, producing transplantable cells from a patient’s own iPS cells is expected to minimize the risk of immune rejection, as the cells are genetically identical to the recipient.
However, current iPS cell manufacturing relies on labor-intensive manual processes performed in specialized facilities, resulting in extremely high production costs—often reaching tens of millions of yen per manufacturing run.
The CiRA Foundation’s clinical-grade iPS cell stock (iPSC Stock), which consists of allogenic iPS cells and is also produced using these conventional processes, faces the same challenge in terms of per-batch manufacturing costs.
By contrast, allogeneic iPS cells offer an important advantage: because pre-manufactured, quality-assured iPS cells can be shared among multiple patients, the cost per-patient can be significantly reduced.
Nevertheless, depending on a patient’s individual characteristics or disease, there are cases in which generating transplantable cells from autologous iPS cells may be more suitable than using allogeneic iPS cells.
To address this challenge, we are working to automate the complex manufacturing processes that have traditionally relied on manual labor, with the goal of producing high-quality autologous iPS cells at significantly lower cost.
Ultimately, we aim to establish a system capable of supplying autologous iPS cells to research institutions and companies at a cost of approximately 1 million yen per patient.

Our ultimate goal is to expand regenerative medicine using autologous iPS cells into a form of treatment that anyone can access.
We aim to establish a system that enables the provision of iPS cells for individual patients at a cost of approximately 1 million yen to research institutions and companies, and to support the initiation of clinical trials by recipient institutions by the end of March 2029.
To achieve this, it is essential not only to reduce manufacturing costs but also to verify the safety and efficacy of cells produced through automated manufacturing. As a first step, the CiRA Foundation will conduct non-clinical (safety) studies prior to human use, ensuring that the cells can be used with confidence in clinical trials conducted by collaborating medical institutions.

We are advancing research and development to enable automated cell production using closed automated processing systems, which allow cells to be expanded while protecting them from contamination—replacing processes that were previously performed manually.
Our specific initiatives include:

1. Development of systems that automate processes from iPS cell generation through differentiation into target cell types
2. Establishment of three-dimensional (3D) culture methods optimized for automated systems
3. Kit-based integration of reagents and materials compatible with automated devices
4. Development of non-destructive quality assessment methods using image-based analysis

By realizing these technologies, we aim to enable the production of cells at substantially lower cost while maintaining high quality.