By Bryan T McConnell, ND, DO
Medicare has begun to cover amniotic membrane allograft product from specific companies for musculoskeletal pathology recently, and a Q code has been assigned to this product. A Q code is assigned to identify drugs, biologicals, and medical equipment or services, and is confirmation that Medicare has recognized the usefulness of this particular Amniotic product.
At the Nature Cure Clinic we are now using BioLab’s Fluid Flow™, an ambient temperature amniotic liquid allograft derived from the amniotic liquid within the placenta to advance soft tissue repair, replacement, and reconstruction.
Relevant Conditions Treated with Fluid Flow Include:
- Degenerative joint disorders such as:
- Sports Injuries
- Joint pain
- Inflammatory conditions such as:
- Soft tissue injuries such as:
- Ligament & Tendon sprains
- Muscle & Meniscus tears
To appreciate how truly innovative this aspect of regenerative medicine is, a person must first understand what amniotic tissue and fluid and amniotic injections are and how amniotic injections, including knee injections and other joint injections, work.
The amniotic membrane is a thick basement membrane and an avascular stromal matrix that together make up the inner layer of the placenta. Amniotic fluid is the fluid that surrounds a baby in the womb before birth. Amniotic fluid protects a fetus and facilitates the exchange of water, nutrients, and biochemical products between the mother and the child she’s carrying.
The amniotic membrane and amniotic fluid are sources of allograft tissue. Allograft is a word meaning that tissue is taken from one individual and given to another, in this case, in the form of BioLab’s Fluid Flow™.
The process is safe for both the donor and the recipient. Potential donors submit their medical and social histories, and the medical team undertakes a thorough risk assessment. This ensures that only healthy mothers donate at the time of their scheduled C-sections.
The FDA has certified that amniotic injections are safe for the recipient as long as the product is minimally manipulated, as BioLab’s Fluid Flow™ is, and as long as it’s homologous. Homologous means that after the amniotic injections, the product performs essentially the same role in the recipient’s body that it did in the donor’s body.
Patients can derive additional peace of mind from knowing that although doctors have only recently found exciting new uses for amniotic injections, amniotic tissue-based products have been in use for over a century.
How Do Amniotic Injections Work?
Amniotic injections contain abundant substances that promote healthy tissue regeneration. These components include cytokines, growth factors, fibrinogen, collagen, hyaluronic acid and messenger RNA.
This stem cell recruitment process is of particular value when a patient receives amniotic injections of BioLab’s Fluid Flow™ to help the body heal.
Generally speaking, amniotic injections can be described as consisting of a multipotent tissue matrix. As such, they function to fill, cover, and protect a defect or void in human tissue.
What Conditions Do Amniotic Injections Help?
Essentially, amniotic injections help with wound care, controlling pain, and orthopedic uses like facilitating repair of tendons, fascia, capsules, and ligaments. They can help chronic tendinopathies, synovial surfaces, tendonitis, and chronic fasciitis (an inflammation of the fascia, which is the connective tissue surrounding muscles, blood vessels and nerves).
To break it down still further, amniotic injections can help patients deal with issues like ACL and MCL tears, biceps and triceps tendonitis, tendinosis, epicondylitis, knee scopes, rotator cuff surgery, facet osteoarthritis, foot and ankle arthroplasty, acromioclavicular joint inflammation, ACL revisions, herniated discs, AVN of the hip and other problems with the knees and hips, plantar fasciitis, post-operative pain resulting from orthopedic and spinal surgery, and the need for tendon and cartilage repair.
How Do Amniotic Injections Work in Wound Care?
In wound care in particular, amniotic injections work well to fight inflammation and promote re-epithelialization, the production and migration of cells to provide temporary protection. Amniotic injections provide a new basement membrane to facilitate the latter process. Additionally, the amniotic injections inhibit TGF-beta signaling and thus, in turn, fibrosis development (a good thing to avoid).
Is There a Risk of Rejection with Amniotic Injections?
Amniotic injections carry no risk of rejection. That’s because they don’t contain HLA-A, -B, or –DR antigens, and these are the substances in the chorion (a membrane that contributes to the formation of the placenta) that can trigger an antigen response. They are extracted during processing.
Do Amniotic Injections Carry Other Risks?
You may have heard that some patients who received a product called Infuse experienced difficulty with bone growing where it didn’t belong. This can’t happen with BioLab’s Fluid Flow™ amniotic injections because the cells inside them are self-signaling. That means they’ll grow bone, but only if and where it’s needed.
How Do Biolab’s Fluid Flow Amniotic Injections Compare to Products Offered to Treat Similar Conditions?
Platelet Rich Plasma (otherwise known as PRP) is extracted from venous blood via centrifuging. It contains some growth factors, but the number of mesenchymal cells present is limited by the donor’s age, his or her medical history, and mechanical degradation in the centrifuge. Amniotic injections don’t come with these limitations. Generally speaking, the younger the tissue being processed, the more MSC’s it’s likely to contain, and of course amniotic tissue is quite young indeed.
Cortisone is used because of its supposed anti-inflammatory properties. But it has not yet been the subject of randomized controlled studies, and it has over 100 potential side effects including muscle and tissue atrophy, heightened glucose levels, and tendon rupture. In an effort to prevent these complications, doctors put a lifetime limit of 3 cortisone injections in any one anatomic area. In contrast, BioLab’s Fluid Flow™ amniotic injections have no side effects, so patients can take them as often as necessary, and there’s no maximum dose.
Does Medical Insurance Reimburse for Amniotic Injections?
Insurance companies sometimes reimburse for amniotic injections. The first step is to send your insurance information and your diagnosis for VOBs (Verification of Benefits). As it stands currently, Medicare picks up 80% of the cost and your secondary insurance usually picks up the remaining 20% of the cost, as long as you have met your deductible. If you have any feeling that BioLab’s Fluid Flow™ amniotic injections might help you, you should definitely discuss the possibility with your physician or Dr McConnell, at Nature Cure Clinic, Phone (520) 399-9212
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