Preclinical testing in animal models, whenever feasible, is especially important for SC based approaches because SCs can act through multiple mechanisms. Physiological

integration and long-lived tissue reconstitution are hallmarks of SC based therapeutics for many disease applications. Animal CBL-0137 supplier models will be important to assess possible adverse effects of implanted cellular products. The need for animal model P5091 manufacturer is especially strong in the case of extensive ex vivo manipulation of cells and/or when the cells have been derived from pluripotent SCs. It should be acknowledged, however, that preclinical assays, including studies in animal models, may provide limited insight into how transplanted human cells will behave in human recipients due to

the context dependent nature of the cell behavior and recipient’s immune response. These uncertainties must be borne in mind during the independent peer review of the preclinical data. Only when the compelling preclinical data are available, careful and incremental testing in patients is justified. Preclinical studies must be subject to rigorous and independent peer review and regulatory oversight prior to the initiation of the clinical trials, in order to ensure that the performance of the clinical studies is scientifically and medically warranted. Because new and unforeseen safety concerns SB-715992 molecular weight may arise with the clinical translation, frequent interaction, between preclinical and clinical investigators, is strongly encouraged. The clinical trials of SC based interventions must follow internationally accepted principles governing the ethical conduct of the clinical research and the protection of the human subjects. Key requirements include regulatory oversight, peer review by an expert panel independent of the investigators and sponsors, fair subject selection, informed consent and patient monitoring. However, there is a number of important SC related issues that merit a special attention Tobramycin [269]. The guidelines concerning the preclinical studies (animal model), clinical

studies have been summarized in the “”Guidelines for the Clinical Translation of Stem Cells”" published in 2008. Conclusions This review shows the most interesting clinical trials in SC biology and regenerative medicine [270–272]. Promising results have been described in disorders, such as diabetes [273] and neurodegenerative diseases [274, 275], where SCs graft can reestablish one or more deficit cellular lineages and, generally, a healthy state. Notably, many clinical studies have underlined the immunomodulatory effect of SCs in autoimmune diseases, such as multiple sclerosis [275], organ transplants [276] and in uncontrolled immune-inflammatory reactions [277–279]. Probably, SCs induce immune suppression and inhibit proliferation of alloreactive T cells [280].