Injuries to the foot and ankle are some of the most common issues for the general population and especially for athletes. The anatomical intricacy of this part of the body, including a more limited blood flow and a much more complex range of motion than any other area in the body, can make treatment extremely challenging. In addition, since the foot is basically the foundation of the lower kinetic chain, anything that happens to the foot or ankle has the potential to affect a part or multiple parts of the body higher up the chain.

When you look at that chain, toes to foot to ankle to knee to hip to pelvis to spine to shoulders to neck, it’s clear that injuries that don’t heal properly can be much more impactful than simply being a painful issue that limits movement of the foot and/or ankle. An unstable ankle, one of the signs that a seemingly simple injury is worse than previously expected, means that the patient can’t rely on that ankle and that, potentially worse, up the line there could be knee or hip or even back issues.

Foot and ankle injuries can result in damaged connective tissue, inflammation, hypermobility, reduced mobility, temporary or chronic pain.

Foot and ankle injuries include:

• Ligament sprain and tearing
• Instability from ankle sprain
• Lack of mobility
• Cartilage fractures
• Plantar fasciitis
• Torn tendons
• Achilles tendon damage
• Slow healing fractures
• Ligament tear or strain
• Osteoarthritis
• Peroneal nerve injury
• Peroneal tendon sprain/tear

Initially, conservative treatment may be the “cure,” and can include NSAIDS, splinting, orthotics, staying off the injured area, and physical therapy. If conservative treatment fails, and symptoms persist, surgical intervention may be required. Even after successful surgery, however, these procedures often result in reduced joint mobility or compromised tendon or ligament strength.

The treatment of Foot and Ankle Osteoarthritis (OAO) is a case in point. Osteoarthritis is a breaking down of a joint’s cartilage. Though sometimes referred to as a noninflammatory arthritis, inflammation can still be a result due to wear and tear.  Total ankle replacement is often prescribed as the only real cure but there are a number of studies that illustrate how often it is necessary to perform secondary surgery to attempt to “fix the fix” of an ankle replacement. Sometimes the only option is to completely remove the hardware and instead perform an ankle fusion.

Multiple types of problems can occur: components of the hardware can loosen, infection can set in, bone fractures occur due to compromise of areas where hardware is attached. New injuries can occur in parts of the foot that were previously healthy.  These include damage caused by pins inserted into previously healthy Achilles tendons, as well as other nerves and tendons in the back of the foot and ankle. In fact, total ankle replacement is considered the best option for end-stage, bone-on-bone grinding of the joint surfaces, the sad hallmark of Ankle Osteoarthritis, but is no longer recommended as a routine solution due to the potential for complications. There are a number of studies that support the use of stem cell medicine for Ankle osteoarthritis, as the first treatment. When it is determined that surgery is the only option, there is research to support the use of stem cell injections to assist the repair work performed during surgery and to aid healing.

Stem cell medicine promotes angiogenesis (the development of new blood vessels) which helps to bring needed nutrients to the site of injury. In addition, it has antimicrobial, anti-adhesive, and anti-inflammatory properties, and because of these attributes, is rapidly becoming a proven success in the treatment of many lower extremity injuries (as well as injuries and issues throughout the body). Stem cell treatments provide excellent immunomodulatory features (the ability to control the catabolic joint environment) as well as regenerative osteochondral characteristics (the ability to heal bone or cartilage defects) which are part of the mechanism of regeneration inherent to stem cell treatments.

Historically, there are clinical reports from as long ago as the 1920’s describing the use of the earliest form of stem cell treatments, amniotic membranes, which were successfully applied to a large number of medical issues. Corneal surgery, plastic surgery, including burns and wound healing, foot and ankle issues, spine repair, nerve healing, tendon repair, all were documented. Amniotic membranes were even used in general surgery.

In patients with acute tendon or musculoskeletal injuries of the foot and ankle, including posterior tibialis tendonitis, Achilles tendonitis, flexor hallucis tendonitis and anterior tendonitis, the use of injectable allograft shows excellent efficacy in reduction of pain and inflammation within six weeks of injection. In general, tendons have little chance to heal due to low blood supply, much like cartilage in people with arthritis.  Stem cell treatments are changing that. In fact, within three weeks of injection, 9 of the 10 patients in one study of acute or chronic tendonitis, had a 75% improvement in pain levels.  An added bonus is that stem cell therapy, due to its rapid results, shows promise in the ability to keep patients dedicated to the treatment regimen more than standard tendon injury treatment techniques.

As the age of the population of the US increases, the need for regenerative medicine treatments will only increase as well. There is already a growing interest in minimally invasive treatments that can replace or at least delay the need for surgery; in addition, there are stem cell treatments that may be able to mitigate or even cure injuries and diseases that were once considered permanent. With growing numbers of more active older adults, the need for these types of therapies will be in even greater demand to improve the outcomes of patients who will aim for a quicker return to activities without the need for lengthy downtime.

To keep up with demands of this rapidly growing medical field, Ariel Med Distribution offers their Bioactive Regenerative Fluid, one of the few injectable stem cell allograft medicines that has received FDA approval for its IND (Independent New Drug) application. This is the gold standard of quality and safety in what has, up to now, been something of a free-for-all market.  Now doctors and their clinics can confidently put aside invasive treatments and surgeries, even if temporarily, and try natural, effective stem cell therapy.

Regenerative medicine may be the fastest growing, most exciting branch of medical research and development today. It is a newer type of research and treatment focused on replacing or regenerating human cells, tissues and ultimately, organs. This is an evolving field which represents a marked shift in medicine: the idea that it is possible to heal and restore function to damaged tissues and organs that previously were considered untreatable or were treatable via surgery and/or extensive medical procedures. In addition, it is hoped that Regenerative medicine will eventually eliminate the often overwhelming demand for organs available for transplant, which will then alleviate the serious issues of dealing with potential organ rejection created when a successful transplant actually takes place.

The human body is made up of many different types of cells, and most cells are specialized to perform particular functions: such as heart muscle cells, or brain cells or bone cells or blood cells. Red blood cells supply oxygen to all the tissues of the body and remove carbon dioxide from the tissue and take it back to the lungs. Stem cells, however, are basically the body’s raw materials: they are the cells from which all other cells with specialized functions are created. Stem cells, derived from a number of different sources, and stem cell therapy, are the main focus of today’s Regenerative medicine movement.

Under the right conditions, stem cells divide to form more cells, referred to as “daughter cells.” Daughter cells either become new stem cells or they become specialized cells with a more specific function. Stem cell reproduction provides new cells for the body as it grows, and replace specialized cells that are damaged or lost. Stem cells have two unique properties that enable them to do this: They can divide over and over again to produce new cells; and as they divide, they can differentiate and change into other types of cells that make up the body. No other cell in the body has the ability to generate new cell types.

There are three main types of stem cell: embryonic stem cells, adult stem cells and induced pluripotent stem cells.

Embryonic stem cells are stem cells derived from the undifferentiated inner mass cells of the earliest stages of a human embryo, called the embryonic blastocyst. Embryonic stem cells supply new cells for an embryo as it grows and eventually develops into a baby. These stem cells are said to be pluripotent, which means they can grow, or “differentiate” into any type of cell in the body.

Adult stem cells supply new cells as an organism grows and replace cells that get damaged. These stem cells are said to be multipotent, which means they can only differentiate into some cells in the body, not any cell, for example:  Blood (or ‘haematopoietic’) stem cells can only replace the various types of cells in the blood.  Skin (or ‘epithelial’) stem cells provide the different types of cells that make up our skin and hair.

Induced pluripotent stem cells (‘iPS cells’) are stem cells that scientists create in the laboratory by taking normal adult cells, generally skin or blood cells, and reprogram them back into an embryonic-like state to become stem cells. Reprogramming happens when scientists “switch on” the signaling genes that tell a stem cell to remain in its embryo state, and “switch off” genes that signal the cells to become specialized. Just like embryonic stem cells, they are pluripotent so they can develop into any cell type, enabling the development of an unlimited source of any type of human cell needed for therapeutic purposes. Eventually, induced pluripotent stem cells generated from a patient in need of an organ transplant could be used to grow new organs that would have a lower risk of being rejected, since the immune system would not be alerted to the presence of foreign tissue.

Stem cells are used in research for a wide range of applications. They are used to help researchers understand the basic biology of how living bodies grow and develop, and how cells become specialized for specific functions in the body and what happens when this process goes wrong. Scientists are also learning what happens in different types of cells affected by disease and dysfunction, and what might be done within cells themselves to correct or change the course of a disease.

Researchers are continually expanding and developing ways of using stem cells to replace cells or tissues that have been damaged. In addition, in understanding the characteristics of stem cells and their development, scientists are working to replicate this process to create new stem cells and make it possible to create all new tissues and organs. A benefit of this research is that lab-developed tissue and organ structures grown from stem cells can be studied to find out how they function and how they are affected by different therapies and drugs. In the future, scientists hope to be able to actually replace diseased or injured tissue and organs with healthy lab-grown replacements.

A great deal of Regenerative medicine research is concerned with cells, tissues and organs that have been permanently damaged by disease, injury and genetic conditions.  Various types of stem cells are being used to generate new cells and tissue that can then be transplanted into the body to replace those that are damaged or lost. Skin stem cells, for example, are being used to generate new skin for people with severe burns.

Adult stem cells have been used for years to treat some conditions. For instance, hematopoietic (blood) stem cells can be used to create all types of blood cells and platelets and are used to provide a source of healthy blood cells for people with some blood conditions, as well as cancer patients who have lost their own blood stem cells during treatment.

Currently, there is research on stem cell therapy for age-related macular degeneration (AMD). This disease often develops because retinal pigment epithelium (RPE) cells stop working. Scientists are using induced pluripotent stem cells (iPSC) to produce new RPE cells in the lab which can replace the damaged cells.

Some of the newest and most exciting breakthroughs in Regenerative Medicine are happening with the tissue that would be considered the “by-products” after the birth of a healthy baby. Rather than using embryonic stem cells and dealing with ethical considerations and consequences, researchers and doctors are using the placenta, the umbilical cord, and the amniotic fetal membrane as a source of cells. The tissues themselves and the cells are used in research as well as in the Regenerative medicine therapies that already exist.

Regenerative medicine is the new frontier of medicine.  The FDA refers to the products created and used here as “Human cell and tissue based products and therapies” (HCT/Ps); it considers this field to be so broad, so complex, and to have so much potential, that there is a continual shift in the regulations that affect the creation and use of stem cell treatments and medicines. As Regenerative medicine products and treatments become more and more prevalent in the healthcare industry, understanding how they repair tissue and provide therapeutic benefit, AND how they are used properly and safely is a vital concern. Ariel Medical is on the forefront of this new frontier, working only with labs that are in compliance with the FDA, and offering the safest and most effective Regenerative medicine available.

We speak to doctors and patients all the time about what we do here at Ariel, and the main question we answer most often is, “What exactly is Bio-Active Regenerative Fluid/liquid allograft/stem cell medicine?” And it’s back-up question is often something along the lines of, “Is it real/ethical/questionable/related to something I read about on the internet/something yucky and unethical/does it work?”

Let’s get down to the facts. Another name for Bio-active regenerative fluid is amnion-derived fluid, and let’s address the “yuckiness” question right away – it is not Amniotic fluid. Amniotic fluid is the liquid a developing fetus floats around in for 9 months. Amniotic fluid is made up of water, proteins, lipids, hormones, urine and other metabolic waste, and electrolytes. Now, there actually ARE labs that create stem cell products derived from amniotic fluid, but the work involved, the filtering required, and the fact that the stem cells are floating around with a multitude of other items non-essential byproducts and waste products does not make it an attractive or optimal choice for us as a high quality product for our doctors and their patients.

We want to use provide THE most potent stem-cell derived medicine products available. In contrast to amniotic fluid, amnion-derived fluid is produced from the culturing of amniotic mesenchymal stem cells and amniotic epithelial cells that are obtained from the amnion of the amniotic membrane. The amnion is the inner layer of the amniotic membrane in which the growing fetus develops – the internal lining of the placenta, and the chorion is the outer layer of the placenta. The amnion layer of the placenta is rich with healthy stem cells that provide growth factors that assist in a fetus’s growth. When these two layers are peeled apart in the lab, the innermost mesenchymal and epithelial stem cells (from the amnion layer) are then released from the amniotic membrane using enzymes.

After the enzymatic release of the cells, these cells are centrifuged, then isolated to be cultured in an expansion medium. That culturing, or growing, of the stem cells is notable because it creates a rich, concentrated “bath” of the most powerful stem cells with no contaminants. The resulting expansion medium becomes conditioned by the cells growing inside it and the cells release a wide variety of desirable growth factors; these growth factors are harvested as amnion-derived fluid.

This description of amnion-derived fluid addresses another cringe-inducing question, and one that also gets into the realm of ethics. “Does this mean you use embryos?” Absolutely not. In fact, our amnion derived bio-active regenerative product is derived from the nutrient rich, ethically sourced, placenta of a healthy baby born by cesarean section.

Another question we are asked regularly: “Is this like stem cells that you can get from my body? I heard you can pull my own stem cells from my hip bone and inject them back into me and it’s supposed to be amazing!” We all have stem cells throughout our bodies, including the types you may have heard of, such as those extracted from our blood and bone marrow. We also have stem cells in our hearts and brains, and other organs and tissues. Mainly, bone and blood stem cells are currently primarily used in stem cell treatments; they are extracted and processed and then injected into the injured area of your body. This can be expensive, it can be painful, and the whole process takes time. There are many names for these various types of treatment; PRP, BMAC, Adipose, etc.

There have been studies on PRP (using the stem cells derived from your blood) and BMAC (using the stem cells derived from your bone marrow) that show the quality of this type of stem cell therapy is affected by many factors including age and sex of the patient, and the handling of the cells by the technician who does the processing. In fact, even in samples from the same patient, there can be a wide latitude of difference of in quality of the extracted cells and therefore wide latitude in the efficacy of the final stem cell treatment.

Another, perhaps more compelling consideration: these are the stem cells of an adult, and unlike the stem cells originating in the amniotic environment, they have limited ability to perform as well as stem cells from the amniotic environment. Your own stem cells don’t have the high level of regenerative or anti-inflammatory properties of compared to stem cells derived from the amnion.

An extraordinary transformation takes place in that rich amniotic environment that starts with 2 cells and ends only 9 months later with a full grown healthy baby. Thinking of potency and quality as our goals, it would seem like the only option to consider, of all possible stem cell types and origins, would be to work with these already powerful amnion-derived stem cells that are then cultured to be more potent than any others. Why would you we use anything less?

Oh, and let’s not forget the last thing: Does stem cell therapy really work? We have many patients and doctors with terrific success stories, and there are growing numbers of clinical trials, case studies, and white papers that prove the efficacy of stem cell therapies. This cutting-edge medicine is used for everything from joint pain, to eye problems, to knee injuries that might ordinarily need surgery, to kidney disease and osteoarthritis.

So yes, it works.