Balancing tissue and tumor formation in regenerative medicine.
A set of general principles can guide preclinical testing strategies for evaluating the tumorigenicity of regenerative medicine products.
Office of Cellular, Tissue, and Gene Therapies, Center for Biologics Evaluation and Research, FDA, Rockville, MD 20852, USA. alexander.bailey@fda.hhs.gov
Alexander M
AM
Bailey
D000818:Animals; D001688:Biological Products / Q000627:therapeutic use; D002471:Cell Transformation, Neoplastic / Q000473:pathology*; D006801:Humans; D044968:Regenerative Medicine / Q000379:methods*; D023822:Tissue Engineering; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products