CiRA Foundation will commence research involving the creation of specified embryos, known as animal aggregation embryos, following official approval from Japan’s Ministry of Education, Culture, Sports, Science and Technology (MEXT).
On July 4, 2025, in compliance with the Act on Regulation of Human Cloning Techniques, the Foundation submitted a “Notification for the Creation of Specified Embryos” to MEXT. Under the Act, creation of such embryos is prohibited for 60 days from acceptance of the notification unless the restriction period is shortened by ministerial decision. On August 8, MEXT officially notified the Foundation that the restriction period would be shortened to that date, enabling the immediate start of the research.

Advancing the “my iPS Cell Project”

Since early 2025, the Foundation has relocated its Research and Development Center to Nakanoshima, Osaka, to fully advance the “my iPS Cell project”. This initiative involves generating induced pluripotent stem (iPS) cells from a patient’s own cells for use in personalized regenerative treatments.
“my iPS Cells” offer the potential to reduce immune rejection and increase treatment safety.
However, producing patient-specific iPS cells is time- and cost-intensive, limiting clinical accessibility.
To address this, the Foundation is pursuing automation and mechanization of the entire workflow—from iPS cell production to creation of transplant-ready cells—thereby enabling more patients to benefit from regenerative therapies.
In the long term, the Foundation aims not only to create transplantable cells from patients’ own cells, but also to generate organs such as hearts for use in regenerative medicine.

Addressing a Global Donor Organ Shortage

This work is driven by the critical shortage of donor organs worldwide. For pediatric patients, the challenge is even greater, as organs must match growth stage and body size. Tragically, some patients pass away while waiting for a suitable donor.
Xenotransplantation—the transplantation of animal organs into humans—has emerged as a potential new approach. In the United States, research teams have attempted to transplant genetically modified pig hearts and kidneys into humans, with promising results but ongoing challenges in preventing immune rejection*1.

The Role of Chimera Technology

The Foundation seeks to use chimera technology—introducing human iPS cells into pig embryos—to generate organs that match the size and function required for pediatric patients.
In the newly authorized study, the Foundation will follow methods reported by a Chinese research group*2 to determine the optimal conditions for human cells to develop in pig embryos. This includes introducing specific genes into human iPS cells and optimizing culture conditions to improve cell compatibility and engraftment rates. The expected outcome is a foundational technology for producing organs such as hearts and kidneys within pigs.

The Role of Chimera Technology

“Our Foundation is undertaking this research out of a strong desire to reduce the number of patients who lose their lives while waiting for transplants. For pediatric patients in particular, the lack of size- and growth-matched organs is a serious problem. This study represents the first step toward the stable production of human-compatible organs and aims to create new options in transplant medicine. From the earliest stages, we are prioritizing both safety and ethics, and we aspire to contribute to the advancement of regenerative medicine worldwide.”

Compliance and Ethics

At this stage, the Foundation is not conducting experiments involving the transfer of created embryos into the uterus of pigs, nor any research using human embryos or oocytes. Should such work become necessary in the future, it will be carried out strictly in accordance with applicable laws and regulations.

References

*¹ Reports on Xenotransplantation in the United States
•Heart Transplant (University of Maryland, January 2022)
On Jan 7, 2022, Dr. Bartley P. Griffith and colleagues transplanted a genetically modified pig heart into a human with terminal heart failure. The patient survived about 60 days, demonstrating feasibility. (NEJM, 2022)

•Second Heart Transplant Attempt (University of Maryland, Sept 2023)
Sept 20, 2023, the second patient to receive a pig heart maintained function for a time but succumbed to immune rejection.

•Kidney Transplants (NYU Langone / UAB, Brain-Dead Models)
NYU reported α-Gal knockout pig kidney transplants in brain-dead humans functioning for up to 32 days (longest to date). UAB reported a 77-hour function in 2021.

*² Report from a Chinese Research Team
Pig embryos genetically modified to lack kidney development (SIX1/SALL1 knockout) were complemented with human iPS cells engineered with anti-apoptotic genes (MYCN, BCL2) and cultured under optimized conditions. After 28 days, kidney precursor structures (mesonephros) formed with 50–65% human-derived cells. (Cell Stem Cell, 2023)