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What is regenerative medicine?
A new age of science has started to grow and take shape to help treat your condition in the early stages before surgical intervention may be necessary. More and more resources are funding scientific studies and testing new alternative options to not simply treat the symptoms of your pain and inflammation, but also target the underlying condition – the breakdown of your connective tissue.
The field of regenerative medicine has the potential to stimulate your own soft tissues to heal by providing a rich and viable source of the necessary building blocks needed to promote correct tissue repair, control inflammation, and help the body heal properly.
There are many options available today that fall under the category of regenerative medicine treatments and its important you understand the differences between all of them when talking with your physician. Read below about some of the most common options available.
Platelet Rich Plasma (PRP)
One of the most well studied and published therapy options available on the market. Originally developed by hematologists, PRP was established to treat patients with thrombocytopenia, a condition of low platelet count. Also called thrombocytes, platelets are critical to the formation of blood clots if a blood vessel becomes damaged. As the years progressed, PRP transitioned into the maxillofacial specialty as PRF, platelet rich fibrin. Scientists recognized fibrin with its potential for adherence and hemostatic properties while PRP with its anti-inflammatory characteristics stimulated cell proliferation. With this new discovery, PRP started to migrate into the field of sports medicine to treat various injuries in the musculoskeletal region. Widespread adoption was further increased after various professional athletes were using this option to treat their injuries many times showing improvement on performance and pain. Today, PRP is being used in the fields of cosmetics for aging skin and hair restoration.
The procedure involves drawing a sample of blood, sending it through a centrifuge to spin down and separating all the various components. Your plasma is placed into a needle and then injected into the diseased area such as your knee or shoulder. The isolated plasma contains rich proteins that aid in cell growth. The biggest pro for PRP therapy is the longevity and proven scientific research available. Some of the drawbacks include having to draw blood and relying on your own body’s varying degree of platelet concentration. Platelet count remains relatively stable during middle age (25–60 years old) but falls in older people. There’s a chance you may not have a full, rich platelet environment in your blood needed to help your damaged tissues in your joint spaces. It’s also possible one round of PRP therapy may not be enough and your physician may advise a second or third round to treat your condition. Studies have shown PRP to be a viable option for many younger patients, but caution should be considered if you are in your later years despite your activity level.
PRP injections are not “FDA-approved”, however it can legally be clinically offered off-label as a viable option to treat musculoskeletal conditions as deemed appropriate by a physician.
Bone Marrow Aspirate Concentrate (BMAC)
Another well-studied procedure utilizing a patient’s own cells and cellular components to treat a damaged area of the body. This therapy involves injecting a needle into your hip bone to extract the soft spongy material called bone marrow in order to isolate various proteins, stem cells, and growth factors.
This isolate concentration is then injected into the joint space to aid in the repair of your connective tissues. The major pro for this procedure is the various types of material your physician is able to gather from your bone marrow. In order for your body to heal properly, autologous cells as well as growth factors are all necessary for proper tissue repair, not just isolated stem cells. The downside of this procedure is a painful injection in your hip and having to spin down the material to provide a viable concentrate. For the same reasons as PRP, the older you are the less viable your own body’s material will be to provide the added benefit.
The FDA regulates BMAC therapy as a permissible option for patients however these techniques are not “approved.” This is due to the guidelines set forth and requires the suspension fluid to be “minimally manipulated” and not be mixed with any additional materials or grown in a lab after extraction.
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Donor Stem Cells (Umbilical Cord Blood, Amniotic Fluid) with FDA Regulation
If you’ve read anything in the news recently, you have probably read about stem cell therapies. There is a difference between a patient’s own tissues and donor tissues utilized for stem cell extracting.
PRP, BMAC, and Adipose are all therapy options that take advantage of a patient’s own tissues. Modern day science has now discovered ways to harvest mesenchymal stem cells from donor umbilical cord blood, amniotic fluids and other like tissues.
These donor tissues are handled initially through tissue banks that are regulated by the FDA as human cells, tissues, and cellular and tissue-based products (HCT/P) intended for implantation, transplantation, infusion or transfer into a human recipient, including hematopoietic stem cells.
Manufacturers of these stem cell products must adhere to strict FDA licensing requirements. They must demonstrate proper handling, and verify the appropriate steps are taken to ensure potency and efficacy. Your physician may offer donated stem cells as a form of therapy treatment, but there are multiple reasons to be concerned.
Not all stem cell products derived from donor tissues are made the same and many of them lack the additional biologic components necessary to maximize the results needed to help regenerate tissues. The FDA also provides strict guidelines, specifically the criterion of minimal manipulation and homologous use.
These harvested stem cells must not be altered in any way during the processing and must be implanted into tissues having an identical function as the donor. In other words, if you take a stem cell from a donated tissue, it must be intended for the SAME function in your own body.
Think of a writing pen. If I “donate” a writing pen to you, the “recipient” in this example, then the writing pen must be used to write ONLY. It can not be used as a paper weight and you can not alter its appearance. It must look and act the same as it was originally intended. If your doctor is offering these options, ask him where these products come from, if they are licensed by the FDA and meeting all the guidelines required. There are hundreds of stem cell companies manufacturing products and making eccentric claims. Be very mindful and research these products ahead of time.
Currently, the only stem cell therapies approved by the FDA use cells from bone marrow or cord blood to treat cancers of the blood and bone marrow.
Adipose-derived Stem Cell (ASC)
The third most common form of regenerative medicine treatment is known as adipose-derived stem cell injections. This procedure requires the physician to extract fat tissue from your abdomen or other area of the body to isolate out stem cells.
These cells are then injected back into the damaged area of your body to help the body repair and heal the surrounding tissues. The advantage for using bone marrow aspirate concentrate vs. adipose-derived is that like adipose, BMAC contains a specific type of stem cell called mesenchymal stem cells (MSCs) that can stimulate wound healing, reduce inflammation, and modulate inflammation, but unlike adipose, it also contains significant numbers of other cell types that can induce new blood vessel growth and reinvigorate tissue that doesn’t have adequate blood supply. The bone marrow cells include cells that can induce angiogenesis; new blood vessel formation. Without new blood vessel formation, no tissue heals properly or completely.
As mentioned earlier, like BMAC therapy, adipose-derived stem cell (ASC) therapy also requires an invasive needle technique to extract your body’s own tissues with may be painful for some. Also, ASCs obtained from older donors appeared to have a slower rate of proliferation, which may have an effect on the quantity of stem cell concentration the physician is able to remove from your fat tissues.
Extracellular Matrix Therapy (ECM)
A fourth form of regenerative medicine therapy options focuses on supplementing and replacing the missing elements that are lost as we age such as collagen, growth factors, and various signaling molecules. The procedure has many names but most commonly goes by ExtraCellular Matrix (ECM), Connective Tissue Matrix (CTM) or Placental Tissue Matrix (PTM) Therapy.
Like all the above, this procedure is performed in a physician’s office and involves a simple injection into the injured area. No painful draws, and no flare or reaction. The materials found in the ECM/CTM are derived from healthy human placental tissues, the richest biologic source known to science and contains all of the native biological components.
The benefit of using donor tissues allows your physician to know exactly how much biologic content is placed into your affected area. Whether you are a young adult or active older patient, you will get the same concentration of content placed into your body to jump start your body’s repair and healing process. This therapy option is a safe alternative with scientific research to support its effectiveness. ECM/CTM therapy has been used by celebrities, professional athletes and our special forces, with the goal to get back to daily activities.
In regards to FDA regulations, these connective tissue matrix or extracellular matrix products are human tissue allografts intended for homologous use to supplement or replace damaged or inadequate connective tissue. Like the options above, these therapy options are considered “investigational” and not “approved” by the FDA. These products are not intended to cure, treat or prevent any disease.
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An alternative solution
Fortunately, there are alternative treatment options that are NOT isolated forms of cryopreserved stem cells and meet all the requirements necessary by the FDA. Our solutions are focused on treating your symptoms in the early stages of deterioration and can provide a variety of health benefits to treat your condition.
These products are designed to help patients who may be suffering from a variety of medical conditions including pain, inflammation, hair loss, and sexual health. Addressing these conditions early may prevent you from having surgery in the future, but always discuss your options with your physician before making any decisions.
We aim to get you back feeling like yourself again.