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Gene and Cellular Medicine Lab
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The lab evaluates the quality and safety of cell products used in regenerative medicine.
AboutAbout the lab
Regenerative Medicine × Regulatory Science
The Division of Cell-Based Therapeutic Products has as its mission building the scientific basis for evaluating the quality, efficacy, and safety of cell-processed products derived from humans or animals, among regenerative medicine products.
Aiming to promote the prompt practical use of effective and safe cell-processed products, the division conducts scientific studies based on regulatory science and disseminates information.
The division has four sections: Sections 1 to 3 handle cell therapy products, tissue-engineered products, and iPS cell-processed products, and Section 4 handles viral safety.
The page registered as the lab website of the Gene and Cellular Medicine Lab is that of the Division of Cell-Based Therapeutic Products at the National Institute of Health Sciences, where the academic advisor, Prof. Yasuda, serves as division head.
Key terms
- Cell therapy product
- A regenerative medicine product used to treat or prevent diseases in humans and animals
- Tissue-engineered product
- A regenerative medicine product used to reconstruct, repair, and form the structure and function of the human or animal body
- iPS cell-processed product
- A regenerative medicine product manufactured by processing iPS cells
ResearchResearch themes
Aiming to ensure the quality, efficacy, and safety of the cell products (cell-processed products) used in regenerative and cell medicine, the lab conducts scientific studies based on regulatory science. It is divided into four areas of responsibility, namely cell therapy products, tissue-engineered products, iPS cell-processed products, and viral safety, and each area carries out its own tests and research.
*Illustrative imageEvaluation of cell therapy products
For cell therapy products, which are regenerative medicine products used to treat or prevent diseases in humans and animals, the lab conducts testing, inspection, trial manufacturing, and the research required for them. Keywords: mesenchymal stromal/stem cells, immune cells, quality evaluation, genomic instability, standardization.
*Illustrative imageEvaluation of tissue-engineered products
For tissue-engineered products, which are regenerative medicine products used to reconstruct, repair, and form the structure and function of the human or animal body, the lab conducts testing, inspection, trial manufacturing, and the research required for them. Keywords: mesenchymal stromal/stem cells, organoids, xenogeneic organ transplantation, quality evaluation, regulatory systems and standards.
*Illustrative imageEvaluation of iPS cell-processed products
For regenerative medicine products manufactured by processing iPS cells, the lab conducts testing, inspection, trial manufacturing, and the research required for them. Keywords: pluripotent stem cells, organoids, quality evaluation, safety evaluation, regulatory systems and standards.
*Illustrative imageViral safety of regenerative medicine products
The lab conducts tests and research on the safety evaluation of regenerative medicine products with respect to infectious agents, and on technologies for detecting, inactivating, and removing infectious agents. Keywords: viral safety, xenotransplantation, development and validation of evaluation methods, next-generation sequencers.
MembersFaculty
The members of the Division of Cell-Based Therapeutic Products consist of the division head, section heads, senior researchers, researchers, fixed-term researchers, technical assistants, and part-time staff.As of 2026
- DirectorSatoshi Yasuda
VoicesStudent voices
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Report an errorAbout the images
The top and research theme images are illustrative and were not taken at the lab. They are cropped from Wikimedia Commons images. Cropped CC BY-SA images are provided under the same CC BY-SA license as the original (version shown on each line).
- Top image: “Culture flasks cabinet in MPI-CBG 01” real name: Matylda Sęk pl.wiki: Cygaretka commons: Cygaretka / CC BY-SA 3.0 (cropped)
- Evaluation of cell therapy products: “Regenerative medicine” Andrewrgross / CC BY-SA 4.0 (cropped)
- Evaluation of tissue-engineered products: “Nanofiber-based engineered cartilage” United States NIH National Institute of Arthrits and Musculoskeletal and Skin Diseases / Public domain (cropped)
- Evaluation of iPS cell-processed products: “Human induced pluripotent stem cell colony ( )” NIH Image Gallery from Bethesda, Maryland, USA / Public domain (cropped)
- Viral safety of regenerative medicine products: “Biological Safety Cabinet (Class II, Type A2) Telstar front view” Ca.garcia.s / CC BY-SA 4.0 (cropped)
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