The CiRA Foundation is promoting the “iPS Cell Stock Project,” which aims to produce and provide clinical-grade iPS cells. This project aspires to advance regenerative medicine with the potential to bring unprecedented treatments to patients suffering from intractable diseases and severe injuries.

The HLA-homozygous iPS cells used in this project are derived from blood or umbilical cord blood generously donated by healthy individuals. Only physicians and clinical research coordinators at Kyoto University Hospital meet the donors in person. The explanation of the study and the informed consent process are carefully conducted by these medical professionals.

Throughout this process, donors often express concerns such as, “I’m worried about my privacy would be invaded like my personal information might be identified,” or “Please make absolutely sure that I cannot be personally identified as the donor of the cell line.” In particular, when umbilical cord blood from children is donated, guardians frequently request strongly that “no future disadvantage should befall my child.”

Despite such concerns and risks, many donors have made the courageous decision to cooperate, motivated by a desire to help those suffering from serious illnesses. We deeply appreciate their generosity and have accepted their donations under the firm promise that personal identification will never occur.

At the same time, research and development in regenerative medicine represent a source of great hope for patients. Realizing these therapies requires rigorous safety evaluation of iPS cells. Since producing iPS cells involves activating specific genes, it is essential to examine whether any genetic or genomic changes have occurred. To achieve this goal, genomic analysis is conducted and, in many cases, the data is shared among researchers—this is regarded as a necessary step to advance regenerative medicine in terms of safety and efficacy.

Therefore, to respect the wishes of our donors certainly and ensure research progress is not hindered, we have now established rules for the handling of genomic and other analytical data related to blood samples, iPS cell stocks and their differentiated cells.

We recognize that there remains a very small, but non-zero, risk that sharing genomic information could lead to the identification or anything unexpected invasion of privacy of our respected donors in the future by more advanced genome sequencing method. Nonetheless, we are committed to minimizing this risk through careful and ongoing efforts.

We believe it is our responsibility to both honor the wishes entrusted to us by donors and protect their privacy, while also meeting the expectations of patients who await new regenerative therapies for long time. We are dedicated to returning the value of donor contributions back to society in a meaningful and substantial way through the social ecosystem aligned with public interest.

Moving forward, we will continue to implement practices that are reassuring to all stakeholders—donors, patients, and researchers alike.

Basic Policies and Rules for Handling Analysis Information Including iPS Cell Stocks and Genomic Data of Their Differentiated Cells

Inquiry

CiRA Foundation
Email: ips-dac*cira-foundation.or.jp
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