Amniotic Fluid (AFA) functions as both a supportive cushion to the fetus and provides a protective environment. AFA is a rich source of nutrients, cytokines, growth factors and mesenchymal stem cells that help promote fetal development. These components of AF have been found to have the biologic properties to fight infection and assist in the repair of damaged tissues outside of the womb and are useful for reparative and regenerative treatment in patients. Amniotic fluid is donated by healthy donors at the time of c section and it's safety is ensured by all donors being screened medically and serologically for transmissible disease. It is processed and procured in accordance to the standards established by the American Association of Tissue Banks (AATB) and US Food and Drug Administration (FDA). Once processed for clinical use it has been shown not to have stem cells present, yet its composition has been shown to have favorable cytokines, growth factors and hyaluronic acid that promote joint homeostasis, decrease joint inflammation and provides a means for tissue repair.
Product
Amniotic fluid functions as a supportive cushion and a protective environment including rich sources of nutrients, cytokines and growth factors that are required for development and maturation. Our manufacturer's proprietary process preserves the original relevant characteristics of the amniotic fluid. Amniotic fluid possesses properties that make it attractive for use in clinical applications (FGF, EGF, PDGF, VEGF, TGFbeta, HA, IL-1 RA, TIMP-1 and TIMP-2). Our amniotic fluid products are ethically collected in accordance with current good tissue practice standards (cGTP), donor and fluid are confirmed negative by FDA registered and CLIA-certified labs (HBsAg, HBcAb, HVCAb, HIVI/2 Ab, HCV NAT, HIV NAT, HBV NAT, RPR/STS, HTLVI/11, and WNV), and terminally sterilized for patient safety. The products are shelf stable and are currently in FDA IND-approved, Phase II multi-center trials (PGF201.)