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Amniotic Fluid is a biological acellular product that is derived from the human amnion. The fluid is rich in Growth Factors and Cytokines including Growth Factors (EGF), transforming Growth Factor Alpha (TGF Alpha), transforming Growth Factor Beta-1 and Insulin-like Growth Factor 1 (IGF1). Importantly, Amniotic Fluid contains factors related to the innate immune system including a spectrum of antimicrobials affective against bacteria, fungi, protozoa and viruses.
Amniotic Fluid is a Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 C.F.R. § 1271.