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Human platelet-derived growth factor-BB (hPDGF-BB) is a basicpolypeptide growth factor released from platelets at the injury site. It is amultifunctional molecule that regulates DNA synthesis and cell division and inducesbiological effects that are implicated in tissue repair, atherosclerosis, inflammatoryresponses, and neoplastic diseases. This paper is an overview of the toxicology datagenerated from a broad testing platform to determine bone, soft tissue, and systemicresponses following administration of rhPDGF-BB. Moreover, the systemic and localtoxicity of recombinant human PDGF-BB (rhPDGF-BB) in combination with eitherbeta-tricalcium phosphate (β-TCP) or collagen combined with β-TCP was studied todetermine dermal sensitization, irritation, intramuscular tissue responses,pyrogenicity, genotoxicity, and hemolytic properties. All data strongly suggest thatrhPDGF-BB either alone or in combination with β-TCP or collagen with β-TCP isbiocompatible and has neither systemic nor local toxicity, supporting its safe use inenhancing wound healing in patients

journal of tissue engineering

Preclinical Toxicology Studies of Recombinant Human Platelet-Derived Growth Factor-BB Either Alone or in Combination with Beta-Tricalcium Phosphate and Type I Collagen