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Amniotic regenerative medicine gets Medicare approval

As first published in The Mining Journal - June 9, 2020

Written by Conway McLean, DPM, Journal columnist

Sports medicine is big business. The fitness boom has pulled the average Joe from his recliner out onto the running track and into the gym. Jim Fixx, who wrote the book that put running on the map, was a key figure in turning this fad into a way of life. Fixx espoused the concept that exercise was good for you. The “trickle-down effect” at least worked here, getting seniors and the middle-aged involved in the pursuit of exercise. And with this trend has come the aches and pains of physical activity.

Those so afflicted have been flocking to their health care provider in droves, asking to be relieved of their orthopedic pain while still being able to pursue their favorite fitness fad. The years take their toll and the hazards of life, be they working in the mines, dodging other 9-to-5’ers rushing to work, or laboring in the trenches of high school football, numerous factors often result in musculoskeletal damage. The human body needs to move but, for many, movement leads to pain.

Orthopedic surgery has advanced tremendously over time, I would say more than most specialties. We can move bones around, lengthen limbs, replace joints, the progress has been phenomenal. Still, surgery entails various difficulties and carries certain risks.

Most operations require some downtime, also known as recovery time (although this period of rest has gotten dramatically shorter with the advent of minimally invasive techniques). Infection is an ever-present risk with all surgeries, and horror stories about post-op infections abound.

Regardless of whether one is athletic or not, the ability to move one’s self, to walk, is critical to both health and quality of life. Adults are barraged on all sides with admonitions they need to exercise, and seniors aren’t exempt. But it’s hard to walk or exercise when you are in pain. A large swathe of our health care resources are directed toward the treatment of these problems, so that more of us can keep active.

Conservative sports medicine care has consisted primarily of physical therapy, bracing, and injections.

The latter has been a mainstay of traditional care of joint and muscular injuries and pain, focusing on alleviating this pain. Unfortunately, these techniques generally provide a short-term solution to a chronic condition. Naturally, a critical question is what is being injected? The standard approach is the use of a corticosteroid, often referred to as cortisone.

How much of what these medications do produces actual healing? Most health care providers will admit we are often just keeping people comfortable while nature performs its healing miracles. Surely there must be some way to jump-start the body’s reparative mechanisms. This is exactly what regenerative medical techniques are all about: facilitating healing. This new branch of therapies has received great attention of late since it promises to do just that: stimulate and boost repair.

Regenerative medicine may be defined as the process of replacing or “regenerating” human cells, tissues or organs to restore or establish normal function. This new direction looks to replace tissues that have been damaged by disease, trauma, or congenital issues rather than the older, more traditional approach of lessening symptoms.

Regenerative techniques hold the promise of replacing organs that have become damaged. By stimulating the body’s own repair mechanisms, new, healthy tissues are built. Regenerative medicine may even enable scientists to grow an organ in the laboratory and safely implant it when the body is unable to heal itself.

The tools utilized to realize these benefits include tissue engineering, genetic manipulation, cellular therapies, and artificial organs.

Another beneficial characteristic of this class of therapies is the lack of contraindications, meaning there is rarely any medical reason one of these cannot be implemented. For those patients who have attempted one of these and had only a partial response, any of the others can be used.

They are also an excellent option for patients who are taking multiple medications, such as blood thinners. This is a significant concern in those considering surgical intervention. Patients do not have to stop these and other medicines when treated with these therapies.

Efforts to enhance healing have generated several new injection therapies such as platelet-rich plasma (PRP), and bone marrow aspirate. Some other examples of regenerative medicine include adipose tissue transfer, extra-corporeal shockwave therapy, and prolotherapy. One of these techniques entails the administration of substances derived from placental tissues and would seem to have many practical and versatile applications. Cryopreserved biologic amniotic tissue has an emerging role in orthopedic medicine, and appears to be beneficial for a host of varying conditions. But these substances do not provide actual living stem cells as has been sometimes claimed. Instead, it provides growth factors, which stimulate the body to mobilize its own stem cells. In case you missed it, stem cells are the holy grail of orthopedic medicine since they can become any kind of tissue, be it bone, skin, or muscle. And they turn into new tissue, meaning normal and healthy.

The first approved product was a preparation of amniotic membrane, the lining of the placenta, for dermal injuries. The first recorded clinical use of amnion tissue was for use in a skin transplantation procedure in 1910. But these amnion allografts (meaning not from self) have grown to become commonplace in ophthalmic surgery, orthopedics, plastic surgery, and especially wound care.

The latest application brought to market is amniotic fluid as a treatment for musculoskeletal problems. A variety of beneficial, biologically-active factors are provided. These factors include proteins, growth factors, and more. Studies as early as 1935 demonstrated benefits to healing. It was previously thought amniotic fluid was beneficial because of the presence of stem cells but clearly this is not the case. As is so often the case in nature, it’s the delicate interplay between the multiple constituents of amniotic fluid which furnishes the benefits. The uses are many, such as acting as a scaffold for tissue growth, improving tissue organization in healing, and in treating an arthritic joint.

The greatest obstacle to the use of regenerative medicine has been a practical one. It has not been a covered benefit of most insurance plans. This has significantly limited its frequency of use. Shockingly, on this topic the news is good. Medicare, our national health care plan (for those over 65 years of age) has approved the injection of an amniotic fluid preparation for the treatment of a great variety of musculoskeletal issues. For example, its track record in the treatment of plantar fasciitis, the most common cause of heel pain (by a mile), is excellent. It thus provides us with a highly effective method of treating common problems like plantar fasciitis without the complications, cost, and downtime of surgery.

Injectable therapies in sports medicine have traditionally provided a short-term solution to long-lasting pathologies. But rarely do they hold the promise of a cure. When that fails, surgery is generally offered. But a necessary factor we must consider is the cost of the operative treatment of musculoskeletal problems, which consumes a massive portion of our health care dollars. Surgery is expensive.

But amniotic materials have many applications in medicine, especially sports medicine. The beneficial properties of amniotic fluid have it poised to become a major player in the healthcare market, especially with the trend-setter, Medicare, leading the way. Regenerative medicine, in the form of an amniotic fluid injection, is now available and, to many, affordable. Chalk one up for the good guy, the average citizen, who will reap the benefits of advanced therapies like regenerative medicine.

Editor’s note: Dr. Conway McLean is a physician practicing foot and ankle medicine in the Upper Peninsula, with a move of his Marquette office to the downtown area. McLean has lectured internationally on wound care and surgery, being double board certified in surgery, and also in wound care. He has a sub-specialty in foot-ankle orthotics. Dr. McLean welcomes questions or comments

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