Amnion FAQ: Top 10 things you should know about the latest in regenerative technologies for animals.

By Brandon Ames, Founder, and CEO of AniCell Biotech

There has been a lot of talk in recent years about regenerative technologies and many are being presented as alternatives to traditional standards of care. Today, there is a new proven human biotechnology emerging in veterinary medicine.

Here are the top 10 things to know about Amnion Regenerative Technologies.

1. What is a regenerative veterinary product?

Regenerative biology deals with the “process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function” [Mason C and Dunnill P (2008). A brief definition of regenerative medicine. Regenerative Medicine. 3 (1): 1–5.]. Regenerative veterinary biology extends this concept to the animal world. In many cases, this emerging biotechnological discipline can be thought of as a branch of tissue engineering applied towards finding solutions for structural repair of tissue damage that best utilizes the body’s own processes.

2. What are the latest types of regenerative therapies?

There are many forms of regenerative technologies such as concentration, in vitro growth, banking, stimulation, or collection.

Platelet Rich Plasma (PRP) – PRP is a concentration technology that starts with a large quantity of whole blood drawn from the animal. The blood is centrifuged to concentrate platelets, the contents of which are sometimes extracted, and reintroduced into an animal at a site of injury. This autologous (self-derived) treatment is believed to help curb inflammation and rebuild damaged tissue due to the action of protease (protein-damaging) inhibitors and fibrin protein, amongst other important biomolecules present.

In vitro growth and transplantation – This process involves harvesting stem cells from an animal’s tissue (e.g. blood or fat tissue), expanding their numbers by allowing growth in tissue culture, and reintroducing them into the animal.

Tissue stimulation – Injured areas can be stimulated using mechanical devices such as Shockwave, Low Light, or Cold Lasers, to spur low-level inflammation and trigger the body’s own healing processes.

The newest biotechnology is the use of Amnion.

3. What is amnion and where does it come from?

Amnion is the tissue that makes up the innermost membrane of the birth sac connected to the placenta that contains the developing animal, prior to birth.  The membrane and surrounding fluid serve to nourish, cushion, and protect the fetus by forming this barrier between the gestational environment and the outside world.  The tissues associated with the amnion are considered “immune privileged” since they do not evoke an immune response from the mother’s system that would otherwise reject the “foreign” body growing during pregnancy.  These tissues are also rich in structural building blocks important to nearly all tissues including a mix of biomolecules such as collagen, hyaluronic acid, carbohydrate-rich proteins (proteoglycans) and other assorted macromolecules.

Amnion is collected non-invasively during the birthing of healthy animals. Animal owners with pregnant pets consent to the collection during the normal birthing of newborns. All deliveries are veterinarian assisted with the health and safety of the animals as the paramount concern.

4. What is the history of the use of amnion as a regenerative treatment?

Amniotic material has been used on skin burns and wounds since the early 1900s. And ophthalmologists began using amnion for eye wounds in the 1940s. [de Rötth, A. (1940). Plastic repair of conjunctival defects with fetal membranes. Arch. Ophthalmol. 23, 522] The FDA recognizes human amnion as an HCT/P (human cells, tissues, and cellular and tissue-based products) when used as a wound covering, regulated under Section 361 of the Public Health Service Act. This designation was reaffirmed for ocular repair in 1999. [Silini AR, et al, (2015) The long path of human placenta and its derivatives in regenerative medicine. Frontiers in Bioengineering and Biotechnology 3: 162]

5. How and why does this technology work?

The amniotic membrane has several properties that make it suitable as a wound covering or “biological bandage”. These include:

1) Biocompatible – Low or non-immunogenicity of the tissue impedes rejection by the animal host [Hori J, et al. (2006) Immunological characteristics of amniotic epithelium. Cornea 25: S53-S58]

2) Durable – The complexity and unique arrangement of specialized structural proteins (collagen, laminin, elastin, proteoglycans, glycoproteins, glycosaminoglycans, etc.) provide substantial mechanical integrity and viscoelasticity, properties that are important for forming a barrier that protects and separates the wound from the outside environment. [Niknejad H, et al. (2008) Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater 15: 88-99]

3) Hydratable – The high concentration of carbohydrate side-groups in the extracellular matrix molecules that comprise the amniotic membrane allow for generous hydration of the biomaterial, which can be beneficial for decreasing wound dehydration and requiring fewer dressing changes [Loeffelbein DJ, et al. (2014) Evaluation of Human Amniotic Membrane as a Wound Dressing for Split-Thickness Skin-Graft Donor Sites. BioMed Res Int 2014: Article ID 572183]

4) Resorbable– Since the natural amniotic membrane biomaterial is resorbable, it does not have to be physically removed from the wound after application which could perturb the wound bed and generate greater trauma. [Branski LK, et al. (2008) Amnion in the treatment of pediatric partial-thickness facial burns. Burns 343: 393-399]

5) Adhesive – As a naturally adhesive substrate and biomaterial, the amnion is adherent to wounds and permissive to cell adhesion and ingrowth, acting as a scaffold when the animal’s body is building new tissue. [Koizumi N, et al. (2007) Comparison of intact and denuded amniotic membrane as a substrate for a cell-suspension culture of human limbal epithelial cells. Graefes Arch Clin Exp Ophthalmol 24: 123]

6) Semipermeable – Gas exchange through the membrane material provides a healthy environment for allowing the animal’s own healing mechanisms to progress. [Hopf HW and Rollins MD. (2006) Wounds: An overview of the role of oxygen. Antioxid Redox Signal 9: 1183-1192]

6. What can these products be used on?

These products perform the same function in the recipient as they did in the donor. In the donor animal, the amniotic membrane provided multiple functions: 1) a barrier function, separating an external and internal environment; 2) a cover function, surrounding the enclosable area; and 3) a protection function, in a durable biocompatible material that is difficult to breach or penetrate. In the recipient, as a wound covering, AniCell’s amniotic membrane-based products provide the same functions. Whether applied to superficial wounds or ocular lesions, the products provide the same great benefits.

7. How long does it take?

Most of the products can be effective with a single application and a one-time visit to the veterinarian. In eyes, the material is applied in the form of a membrane or drops and for superficial wounds, the material topically adheres to form a biological bandage. Recovery times can vary depending on the age and health of the animal.

8. What are the risks?

If we draw a comparison between AniCell’s amniotic tissue-based products to those used in humans, there are few risks. Since 1910, there have been no documented serious adverse events in scientific literature.  Some patients experienced injection point selling or initial discomfort but all have subsided within 24-72 hours.

9. Is the use of amnion invasive like other regenerative products?

No. Due to its anti-reactive properties, amnion is not invasive at all. AniCell’s products can be banked by your veterinarian and used the same day as the diagnosis in the field during a farm call. These products are administered topically for superficial wound during cleaning and debridement or as an implantable for tendon and ligament injuries.

10. Where can I find Amniotic Treatments?

The use of amnion must be performed by a veterinarian. Simply ask your veterinarian about this type of regenerative technology and whether it could be a suitable alternative to the typical standard of care.