OVERVIEW OF PLACENTAL TISSUE
The placenta is a maternal-fetal organ that develops from the fetus and attaches to the uterus during pregnancy. The placenta is responsible for, among other things, providing the growing fetus with oxygen and nutrients while at the same time removing toxins.1 It also serves as a barrier between maternal and fetal compartments. Once the baby is born, the placenta detaches from the uterine wall and is expelled from the body. Placental tissue can be harvested after a healthy, concluded birth and then processed into a human, placental tissue allograft.
ACELLULAR PLACENTAL ECM TISSUE ALLOGRAFTS
An acellular, placental extracellular matrix allograft is a soft connective tissue graft generated by a decellularization4 process that preserves the intact extracellular placental matrix. Upon implantation, this structure may serve as a scaffold to support the repair, reconstruction, replacement, or supplementation of the patient’s own tissues
PLACENTAL TISSUES ARE FDA REGULATED
Placental-derived tissue is regulated by the FDA under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.
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PLACENTAL ALLOGRAFTS DISCLAIMER
Disclaimer: Certain placental allografts consist of acellular, minimally manipulated tissues intended for homologous use to supplement patient’s own tissue. Tissue allografts are classified by the Food and Drug Administration (FDA) as Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 361 of the Public Health Service (PHS) Act. As an HCT/P regulated solely under the Section 361 of the PHS Act, tissue allografts are exempt from FDA pre-market review, clearance, and approval from FDA. Please consult your doctor to see if a tissue allograft is right for you. No medical advice has been offered herein. None of the statements in this brochure have been evaluated by the FDA. Placental-derived allografts are not intended to diagnose, treat, cure or prevent any disease and should not be used for the treatment of COVID-19.
