Birth-tissue-derived products have attracted attention in recent years as a source of multiple mediators that may be used clinically in veterinary and human medicine. Amniotic fluid is known to contain enzyme inhibitors and multiple cell types derived from the developing fetus, including broadly multipotent amniotic fluid stem cells. In addition to the cells, the extracellular matrix of the amniotic membrane is inherently rich in growth factors, cytokines, and other unique proteins.
The first report on the therapeutic use of amnion was published in 1910 when J. W. Davis, MD, described a series of cases using fetal membranes as skin grafts. Since that time, several components of birth-tissue-derived products have been identified that make them amenable to clinical applications: amniotic cells produce growth factors, cytokines, antibacterial peptides, anti-inflammatory agents, and the tissue exhibits low immunogenicity.
These products are noted to have many potentially beneficial effects when used as therapeutic agents. They have demonstrated the ability to reduce pain, scarring, and inflammation; modulate angiogenesis; and enhance tissue healing, and they possess antimicrobial properties. Additionally, the extracellular matrix can serve as a scaffold for cell proliferation and differentiation. These characteristics have led to experimental and clinical investigations of birth-tissue-derived products as therapy in many areas, including neurological, orthopedic, dermatological, ophthalmological, and dental disease. Clinical reports of positive outcomes using a variety of biologics are widespread in both the human and veterinary literature.
Thanks to advances in biotechnology, techniques of cell culture and engineering of the medium allows for a degree of selectivity for specific growth factors included in, or excluded from, an individual birth-tissue-derived product. Scientists can formulate birth-tissue-derived products for specific, targeted indications by manipulating the relative concentrations of biologic factors present. This technology also allows for products that have a consistent, known formulation with quantifiable levels of factors and may contain active factors that elute from the tissue more slowly over a period of days to weeks.
These products are formulated under strict aseptic conditions in accordance with current Good Manufacturing Practices (cGMP) and are available directly off-the-shelf. As opposed to birth-tissue-derived products’ off-the-shelf availability, most other biologically derived products require time for processing of tissue or blood from the patient and there is documented wide variability in the final composition and concentration of active factors in many of these products.
The tissues used by Hilltop Biosciences are not from “purpose-bred” mares. The tissues are harvested from privately owned broodmares that have foaled naturally. All the mares are regularly screened for infectious diseases, and USDA guidelines and recommendations for equine vaccines and serum products are followed.
Birth-tissue-derived products rely on the wide array of cytokines, growth factors, and enzyme inhibitors produced by amniotic cells, and, acting in concert, they may provide a range of beneficial clinical effects. Technological advances in the means of recovering, processing, and culturing birth tissues enables formulation of a product containing factors biologically important for promoting healing of tissues with known, consistent, and targeted factor profiles.
A Hilltop Biosciences birth-tissue-derived product has been formulated specifically for use in the management of soft tissue injuries in horses. Clinical benefits have been demonstrated in numerous horses receiving intra- or perilesional injections to the flexor tendons, suspensory ligaments, and other soft tissue injuries.