Method for increasing the safety of tissue engineered products for clinical useRegenerative medicine is the replacement of diseased tissues or organs with laboratory-made cellular products (tissue engineered products = TEPs). In recent years stem cells have emerged as the most important source for TEPs. However, stem cell therapies (e.g. TEPs) carry the risk of uncontrolled cell growth (teratoma formation). In order to solve this problem, the present invention uses radiation as a non-genetic and easily practicable approach of mitotic inactivation without loss of function. Upon irradiation, there are no chemical or genetic residues or traces as with other processes that are highly problematic for a cell product from a regulatory point of view. ChallengeThe goal of regenerative medicine is the replacement of diseased tissues or organs with laboratory-made cellular products (tissue engineered products = TEPs). In recent years stem cells have emerged as the most important source of "replacement cells". However, uncontrolled differentiation can lead to tumors (teratomas). This is a critical safety issue in using any cellular product of pluripotent stem cells. Potential solutions to this problem include positive or negative selection of therapeutical cells (e.g. via antibiotic resistance, suicide genes, fluorescent reporter genes, surface marker-based selection). However, these procedures are costly and it is unclear whether they would be applicable from a regulatory point of view. Thus, there is a need for a reliable, easy-to-perform method for mitotic inactivation of cellular products from pluripotent stem cells. Our SolutionThe present invention uses radiation as a non-genetic and easily practicable approach of mitotic inactivation. Irradiation is a suitable method for mitotic inactivation in TEPs, especially muscular TEPs, without loss of function. Two alternative approaches are chosen for this: Advantages
![]() ApplicationsRegenerative medicine (replacement of diseased tissues). Developmental StatusProof of concept in laboratory setting. Patent StatusWe have filed a German priority patent application (Applicant: Georg-August-Universität Göttingen public law foundation). ContactDr. Stefan Uhle |