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The Biology Behind BioXclude ®
The Biology Behind BioXclude®
The Biology Behind BioXclude ®

The Amniotic Sac
The amniotic sac is formed by a thin pair of membranes, the amnion and chorion, which hold a developing embryo (and later fetus) until shortly before birth. In conjunction with the placenta, the amniotic sac creates an enclosed, fluid-filled bag that protects the developing fetus from biological threats as well as mechanical stresses.
  • Dynamic Barrier Membrane: The amniotic sac is the barrier between the mother and developing child, requiring that it have a unique combination of strength and flexibility to maintain its integrity while simultaneously allowing fetal movement and growth
  • Infection Prevention: Soluble factors present in the chorion layer of the amniotic sac are thought to limit uterine infections, helping to maintain a healthy environment throughout the pregnancy
  • Immune Privilege: The tissues of the amniotic sac employ biological “cloaking” mechanisms to prevent the mother’s immune system from attacking what It could perceive as a foreign body
  • Growth Factors: The amnion and chorion layers are continually expanding to accommodate the rapid growth of the fetus, requiring that the tissues maintain high levels of growth factors to continually activate tissue development.
First and foremost, BioXclude is a dynamic barrier membrane, with tough but flexible physical properties that make it an ideal membrane product for use in a range of dentoalveolar surgical procedures. The Collagen IV- and laminin-rich basement membrane layers of BioXclude provide robust barrier function as well as a natural substrate for cellular attachment, movement, and proliferation. Basement membranes are found throughout the body, acting as key delineators between different tissue types. In this way, cells of the body are programmed to recognize basement membranes, helping them to orient themselves within tissues. This is particularly important in wound healing processes where basement membranes are either damaged or missing altogether. The use of BioXclude in surgical applications, the intact basement membranes of the amnion and chorion membranes can act as a provisional barrier and provide critical cues to cells involved in wound healing and tissue regeneration/repair processes.

Active infections will delay or prevent the progression of wound healing and tissue regeneration/repair processes. If infections are present, the body is forced to direct its energy at fighting the infection, leading to destructive inflammatory processes that accompany the immune system’s infection fighting response. Inflammation is a natural stage of acute wound healing progression, but when inflammation persists, as would occur if there is an active infection, wound healing will be delayed. The presence of infection-fighting peptides found in BioXclude, which are thought to contribute to preventing uterine infections during pregnancy, can help to prevent the re-establishment of infections within surgical sites, allowing wound healing to progress without delay.

Allograft tissues are often associated with a significant risk for eliciting adverse immune responses in recipient. This occurs because everyone’s immune system is tuned to identify “self” from “non-self”. When cells of the immune system encounter things that they identify as “non-self” (bacteria, virus, splinters, etc.), they attempt to destroy and remove the invader. Transplanted allograft tissues (skin, heart, lung, kidney, etc.), though of human origin, can still be identified as “non-self” by the recipient’s immune system and, therefore, cause an immune response against it. Placental membranes, however, are specifically built to avoid detection by the mother’s immune system. In this way, they “cloak” the developing baby and prevent an immune attack that would jeopardize the pregnancy. Because they do not present signals that would alert the immune system of the recipient, placental allograft tissues are uniquely suited for use in medical applications.

Inflammation, a direct result of the body’s immune system responding to the presence of pathogens or injury, is an active, aggressive process aimed at eliminating the cause of cell injury, clearing out damaged cells and tissues, and initiating tissue repair. Though a critical stage in fighting infections and initiating wound healing processes, excessive or prolonged inflammation can result in damage in the surrounding tissues. Because of this, excessive or prolonged inflammation within the womb presents a clear danger to developing fetus. Immunomodulatory cytokines that are naturally present in the membranes of the amniotic sac can act to temper inflammatory processes, helping to maintain a healthy environment for fetal development. The rich blend of cytokines that temper inflammatory processes in the womb are the same factors that temper inflammation during wound healing. By maintaining and preserving these factors within the amnion and chorion membranes of BioXclude, our proprietary process creates an allograft membrane product with high levels of these immunomodulatory cytokines.

Growth factors are well-known for their ability to stimulate cellular activities, including proliferation, migration, differentiation, and matrix deposition. These activities are critical to wound healing processes. Though the amniotic sac would not be considered a wound healing tissue, it does contain a reservoir of growth factors involved in the maintenance and growth of the membrane throughout the pregnancy. Because tissue growth and development involves many of the same processes as wound healing and tissue repair/regeneration, there is considerable overlap between the growth factors involved in directing these seemingly different biological events. To date, over 200 growth factors have been identified in BioXclude that are known to play active roles in cellular proliferation and migration, stem cell recruitment, and matrix deposition. Moreover, these factors, when released from rehydrated, processed amnion-chorion membranes have been shown to remain active, eliciting growth responses in cultured cells.

Ultimately, the biology behind BioXclude lies in the biology behind the amniotic sac. What makes the amniotic sac special is the same thing that makes BioXclude special.