Despite its vital role in many areas of life, the placenta is a source of great mystery and potential. The National Institute of Child Health and Human Development calls the placenta “the least understood human organ and arguably one of the more important.”
Yet, the placenta is no doubt a phenomenally rich source of growth factors, which help cells regenerate. Advances in the preparation of amniotic tissues as well as the amniotic fluid have unveiled applications across a broad range of therapeutic categories including ophthalmology, burns, spine, chronic wounds, dental, orthopedic surgery, sports medicine, and urology.
“It may come as a surprise how valuable the placenta is, not only to newborns’ health but as the basis of regenerative medicine for people throughout their lives,” says Charles Zelen, DPM, who has conducted extensive clinical research on use of dehydrated human amnion/chorion membrane (dHACM) and is a podiatrist at Foot & Ankle Associates in Salem, Virginia. “Published clinical evidence in support of its value in wound care, particularly in patients with diabetes, is mounting and that’s only the beginning.”
Regenerative medicine is now one of the most exciting areas of healthcare; the Mayo Clinic considers it “game-changing.” It is also one of the most potentially lucrative. The opportunity in diabetes alone is estimated at more than $3 billion. Some estimate regenerative medicine to mature into a $24.7 billion market by 2017.
Over A Century of Healing
As new as it seems, the human placenta has been traditionally used in Chinese medicine for centuries, the earliest study published in 1593. The first reports showing that the placenta also harbors powerful stem cells, eventually giving rise to their potential use in regenerative medicine, were published many years later. The two outside membrane layers of the placenta were first used as a biologic scaffold in 1910 for the treatment of skin wounds. It wasn’t until 1938 that use of amniotic fluid as a treatment for orthopedic conditions was recorded.
Amniotic Membrane: What It Is, How It Works
Human amniotic membrane is a naturally derived, biologically active and mechanically robust barrier comprised of two distinct but conjoined layers—the amnion, which faces the fetus, and chorion, which faces the uterus. These are organized, collagen-rich extracellular matrices, governed by growth factors, cytokines and chemokines. When applied to wounds, in the form of allografts, these growth factors work by attracting the body’s own cells so they can proliferate and aid in tissue regeneration.
Early Challenges and New Solutions for Clinical Practice
Among the earliest challenges with using the placenta in healing were issues relative to obtaining, preparing, and storing this tissue for use in clinical practice, as well as concern regarding the potential for infectious disease transmission. Sterilizing and processing this delicate tissue is critical for companies active in this space.
Advanced wound care products originally contained living cells that have been employed to aid in growth factor production. These tissue-engineered products introduced about 15 years ago by companies such as Organogenesis, Inc. were considered breakthrough technology and the treatment of choice. Living cells, however, are fragile and vulnerable, surviving for only about 72 hours. They also require refrigeration, thawing, and careful clinician handling—dramatically increasing the space requirements in clinician offices, the potential for waste, and the cost of use per patient.
Technology has considerably advanced since then. A proprietary processing technique was developed by MiMedx in 2011 to gently process, sterilize, and dehydrate donated placental tissue obtained from screened and tested pregnant women scheduled to undergo Cesarean deliveries. This proprietary process creates a dehydrated human amnion/chorion membrane allograft (EpiFix®, AmnioFix®) that can be stored at ambient temperature for up to five years.
Amniotic fluid, in utero, is predominantly composed of water that is derived from maternal plasma and contains growth factors, carbohydrates, proteins, lipids, electrolytes and other nutrients as well as hyaluronic acid (HA), a principle component that provides viscosity and lubrication in the synovial fluid that surrounds joints.
Amniotic fluid has been proposed as a potential therapy for osteoarthritis of the knees and preliminary studies have been encouraging.
Existing Markets and Emerging Opportunities
The wound care market, including burn care, for amniotic membrane products is estimated to be $7.7 billion. A significant portion of that market currently consists of treatment of diabetic foot ulcers (DFUs), a common complication developing in up to 25% of people with diabetes. These wounds are notoriously slow to heal and even in cases in which primary healing is achieved, ulcers frequently recur. An optimal treatment for DFUs would support both rapid and long-term healing.
Scientific and clinical trials demonstrate the clinical and cost effectiveness of dHACM in the effective, safe, and rapid closure of DFUs.
The first, multicenter, randomized comparative-effectiveness study was published in 2014 and examined side-by-side the performance, outcomes, and utilization of standard of care and two advanced amniotic membrane therapies, Apligraf® and EpiFix, for treatment of chronic lower-extremity DFUs. The healing rate with EpiFix was greater than 90%, healing the majority of wounds in an average of just over two weeks, significantly faster than both other options.
The next frontier for products derived from the placenta includes surgical applications, a market estimated to be nearly $3 billion. Procedures in which advanced therapy with amniotic membrane products are expected to play a significant role in healing at the surgical site include urology, OB/gynecology, plastic surgery and reconstruction, as well as general, orthopedic and colorectal surgery.
Interest in, and utilization of, amniotic membrane tissue allografts has been steadily escalating. As with any new technology with significant promise and market opportunity, issues can arise, especially given the complexity involved. Ongoing rigor and a commitment to the discipline of scientific and clinical testing will help safely and appropriately unlock the potential benefits of the unique qualities and possibilities of amniotic membrane to enhance healing, reduce scar tissue formation, and modulate inflammation.
Millions of placentas are discarded as waste every day. But if ever there was an evidence-based medical solution for conditions from pre-cradle to pre-grave, the placenta is it.