Safety Evaluation office is responsible for evaluating the safety of regenerative medicine products when they are used in medical treatment or research. Specifically, this department conducts tests to check for contamination with general bacteria, fungi, mycoplasma, endotoxins, viruses, etc., in order to prevent harmful reactions due to bacterial infection, viral infection, or endotoxins that may accompany the administration of regenerative medicine products.

Now, regenerative medicine products are defined as those specified by government ordinance, which are (1) human or animal cells that have been processed by culturing or other means, and which are used for the purpose of a) rebuilding, repairing, or forming the structure or function of the body, b) treating or preventing disease, or (2) being introduced into human cells for the purpose of gene therapy.

Tokai University Hospital 's regenerative medicine efforts, led by Professor Masato Sato of the Department of Orthopedic plastic surgery, Tokai University School of Medicine, include "cartilage regeneration therapy using autologous cell sheets" for patients with knee osteoarthritis as Advanced Medical Treatment B. This involves creating a cartilage cell sheet from harvested joint tissue (cartilage and synovial tissue), which is then transplanted into the cartilage defect during high tibial osteotomy. Platelet-rich plasma (PRP) therapy for joint diseases is also provided to many patients.