title: Nonclinical safety strategies for stem cell therapies.
abstract: Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.
authors.affiliation: Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ, UK. michaela_sharpe@yahoo.com
authors.forename: Michaela E
authors.initials: ME
authors.lastname: Sharpe
authors.forename: Daniel
authors.initials: D
authors.lastname: Morton
authors.forename: Annamaria
authors.initials: A
authors.lastname: Rossi
mesh_terms: D000818:Animals; D006084:Graft Rejection / Q000276:immunology; D006801:Humans; D051379:Mice; D009369:Neoplasms / Q000209:etiology; D061214:Patient Safety; D039904:Pluripotent Stem Cells / Q000276:immunology; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D013234:Stem Cells / Q000276:immunology; D013724:Teratoma / Q000209:etiology