- Case review of non-clinical study using stem cell in Chemon Inc.
Non-clinical tests are an essential process to obtain information on clinical trials in the course
of developing new drugs and are not an exception to the development of stem cell-based
therapeutics. Since stem cells differ from general small molecular drugs, the specificity of non-
clinical trials should be considered a lot. There is also a difficulty because the history of drug
development is short and historical data is not accumulated. Of particular concern are animal
models, methods of administration, in vivo distribution and microenvironment, tumorigenicity tests,
in vivo differentiation and immune rejection and persistence. In this presentation, we will look at
examples of non-clinical tests using stem cells performed by Chemon Inc. so that we can refer
them to future development of new stem cell drugs.