Science of Amniotic Tissue
The human body has a near continuous network of membranes from top to bottom, front to back which cover virtually every muscle, nerve, bone and internal organ. The function of these internal membranes is to cover, protect and allow adjacent structures to glide against each other without sticking or tethering. When those membranes are disrupted by trauma or surgery the protective covering function of those membranes is lost.
During gestation and in the development stage of the mesoderm, bone, muscles, nerves, tendons and fascia membranes develop as one basic tissue with varying degrees of elasticity, stability and mutability. These are the family of fascia membranes which include amnion and these are the most elastic membranes in the human body and change most extensively when injured.
There are different types of fascia membranes – superficial fascia which house much of the body fat and stretch and adjust to strains of all kinds. Superficial fascia is what allows an athlete’s muscles to glide so well under the skin. Deep fascia is a denser material and functions to permit structures to glide and slide over each other. An example of deep fascia is Dural membrane which covers the spine.
When these membranes are injured, stressed or cut as part of a surgical intervention, it can leave underlying tissue exposed. Exposed muscle, bone, tendons, nerves, and internal organs can be re-covered by wrapping or enveloping the exposed tissue with a similar membrane. Just as human bone allografts are used to fill voids in human bone, a human membrane allograft would be used to re-cover an injured human membrane. AFCell offers a human membrane material similar to that of this injured sheathing.
Over the years many products have been introduced to help counteract the post operative problems that are created by damage to this membrane network. These products are almost always either polymer based, bovine collagen based or hyaluronic acid based and they all work to varying degrees.
AmnioClear® is an additional tool the surgeon can effectively use to re-cover internal structures with a consistently processed, sterile and properly sized human membrane.
Clinical History
The fetal membrane including amnion and chorion has been used in surgeries documented as early as 1910. See Trelford and Trelford-Sauder, The Amnion in Surgery, Past and Present, 134 AM J. OBSTET. GYNECOL 833 (1979). Amnioplastin, an isolated and chemically processed amniotic membrane, was used for continual dural repair, peripheral nerve injuries, conjunctival graft and flexor and tendon repair. See e.g., Chao et al., “A New Method of Preventing Adhesions: the Use of Amnioplastin after Craniotomy,” The British Medical Journal, March 30, 1940.
The amnion has been used as a covering for damaged membranes, e.g., as a graft in surgical reconstruction forming artificial vaginas or over the surgical defect of total glossectomy, as a dressing for burns, and on full-thickness skin wounds or in omphalocele.
In recent years, there have been renewed interests in the application of amnion as a covering in ocular surface reconstruction, for example, as an allograft for repairing corneal defects. See, for example, Tsai and Tseng, Cornea. 1994 Sep;13(5):389–400.
Despite the clear clinical and published record regarding the use of amnion in surgery as a covering, issues regarding reproducibility, safety and the precise form of amnion for each prospective indication have prevented amnion from achieving broad commercial distribution.
AFCell was formed to systemically address these issues and to locate and work with suppliers to implement improved methods for preparing and supplying amnion as well as such other birth tissue products as Chorion and amniotic fluid. Amnion is the human allograft raw material for addressing the heretofore ignored surgical issue of human fascia membrane transplant.
The following table illustrates the large body of clinical papers describing the use of human placental tissue transplants in surgery as a membrane cover.
Peer Review Journals Have Been Publishing Case Studies of the Clinical Use of Amniotic Materials as a membrane covering.
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