Product Overview
The human body relies extensively on a thin, elastic membrane network to position, tone, cover, lubricate, protect and allow articulating hard and soft tissues (e.g. muscles) to glide freely and are, therefore, critical to the body’s ability to move. The following are examples of this membrane network;

• Superficial fascia (aka hyperdermis) – between the skin and muscles
• Periosteum – covers each bone
• Perichondrium – covers cartilage
• Synovial – lines joint cavities
• Amnion – lines the placenta and covers the fetus in amniotic fluid
• Deep fascia – covers each skeletal muscle
• Meninges – covers the brain and spinal cord

Surgical intervention invariably disrupts one or more of these membranes. When that occurs the patient can experience post operative pain, reduced mobility, less lubrication between articulating tissues (e.g. bone on bone grinding or tethering of muscles or nerves rubbing with adjacent tissues) and shock absorption and a heightened risk of post operative scarring or adhesions.

While AmnioClear® is not a complete replacement for periosteum, it is the first human allograft membrane transplant for surgical use and is designed to be placed over damaged internal membranes. It is derived from the largest continuous sheet of human fascia membrane available for transplant -- the inner lining of the placenta.

AmnioClear® is recovered from human donors who are undergoing a Ceasarean Section birth. Each placental donor provides enough amniotic membrane to cover, on average, a 15 cm by 15 cm space. AFCell through its processing partners creates a variety of shapes and sizes of amniotic tissue membrane to accommodate virtually every type of membrane transplant need during surgery.

Safety and Testing
Each piece of AmnioClear is rigorously screened by a CLIA-certified lab using the following tests:

• anti-HIV-1 and anti-HIV-2
• HIV-1/Hepatitis C by Transcription Mediated Amplification
• hepatitis B surface antigen (HBsAg)
• hepatitis B total core antibody
• antibodies to the hepatitis C virus (anti-HCV)
• antibodies to human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II)
• syphilis using FDA-licensed tests. If the blood sample to be used for syphilis screening is determined and documented to be unacceptable for the screening assay (e.g. hemolysis, sample testing time restriction) then an FDA-licensed treponemal-specific confirmatory assay may be performed instead (e.g. FTA-Abs)
  

Processing
AmnioClear® is produced in accordance with the FDA regulation 21CFR1271 (GTP). Human Cell and Tissue Product (HCT/P) manufacturing records are retained in accordance with GTP regulations and copies are available upon request. All allografts are processed aseptically, sterilized and packaged to maintain the integrity of the product.

Packaging & Storage AmnioClear® is packaged in a double peel pouch and outer box. The inner peel pouch and tissue product are supplied sterile and may be placed directly into the sterile field. Included in the packaging are an Allograft Tissue Tracing Record and a set of patient labels. AmnioClear® is intended for single patient, one time use only. Product is stable at room temperature. Package should be discarded after expiration date.