Supporting the Path to Medical Applications

"There are numerous regulations and guidelines that must be followed when moving basic research toward clinical application," said Shigemasa. "My role is to ensure these procedures are handled smoothly so that research projects can proceed without issues."

Shigemasa is deeply involved in planning research that aims to apply CiRA’s research findings to medicine. Each clinical research¹⁾ is subject to different laws and regulations, requiring the identification of the appropriate systems and rules and a proper response accordingly. In the case of regenerative medicine research, there are often many unprecedented cases, and planning and documentation for non-clinical studies²⁾ often require consultation with regulatory authorities.

Ensuring Safety Before Efficacy

"When using cells or drugs in humans for the first time, unexpected health risks can arise—sometimes even life-threatening ones," Shigemasa explained. "That’s why safety must be thoroughly examined before evaluating efficacy. In addition, materials used in basic research may not be suitable for human use."

When transitioning to non-clinical trials form basic research, it is essential to switch to safe materials and verify that they still yield reliable and reproducible results. Shigemasa often conducts detailed investigations into the composition and manufacturing processes of materials, sometimes under confidentiality agreements with suppliers.

"These investigations are labor-intensive," she noted, "but the findings can benefit future research. I hope to share this information with other researchers at CiRA whenever possible."

Experience-Driven Support

Shigemasa’s journey began in 2014 when she joined Professor Koji Eto’s lab at CiRA as a technician. She helped prepare for a clinical study involving iPS cell-based autologous platelet transplantation for a patient with thrombocytopenia. That experience laid the foundation for her current role.

"Back then, everything—from cell transport to ethics applications—was new. That trial-and-error experience is invaluable now."

Researchers at CiRA often express the need for support in preparing documents and navigating procedures for medical applications. In response, the Research Plan Support Group was formed, with Shigemasa at the helm.

Looking Ahead

Her work involves coordinating with other departments, including the CiRA Ethical Review Committee, to ensure smooth progress. "Even if one procedure goes well, the research cannot move forward unless everything else is ready," she said. "The best moment is when everything aligns and we can say, 'It worked!'"

Now in its third year, the group is a trusted resource for many researchers. "When I talk to researchers, they share a wide range of needs. I want to expand our services as much as possible and be someone they feel comfortable coming back to—not just for medical applications support, but for any research-related consultation."

As a bridge between basic research and clinical application, the Research Plan Support Group continues to evolve and support CiRA’s mission.