Written by Dr. Monte Hessler
Regenerative medicine refers to therapies that are able to repair, restore and regenerate damaged tissues in the body. These treatments represent a significant advancement from traditional ones that only offer symptom relief as a proverbial “band-aid”. Regenerative procedures come in two forms. Those that require a biologic harvest from the patient (bone marrow or adipose tissue), or those that come from an external source (e.g. PRP Therapy, amniotic fluid/membrane, and umbilical cord blood/tissue). There are significant myths and misinformation that have been propagated regarding the external source regenerative biologics. A lot of these myths are disseminated by industry competitors who have presented biased and manipulated data to confuse prospective patients.
Known as the “products of conception”, the regenerative materials from amniotic and umbilical tissue include the following:
- Amniotic Fluid
- Placental membrane
- Umbilical Cord Tissue
- Umbilical Cord Blood
- Wharton’s Jelly
Research performed on the products of conception have shown several benefits to what the materials contain including:
- High numbers of Stem Cells
- Concentrations of Growth Factors
- High numbers of Cytokines
- Additional elements including exosomes, microsomes, secretomes, mRNA. The best analogy applicable is that the products of conception produce regenerative materials that contain a full “orchestra” of components to treat patients!
How are they acquired? The amniotic and umbilical cord tissues are obtained from healthy, consenting donors who are under the age of 35 and undergoing a scheduled c-section. The FDA strictly regulates the process of how these tissues are acquired, tested, processed and stored to ensure the highest level of patient safety. During a normal, scheduled c-section, the products of conception are normally discarded. This includes the amniotic fluid, placenta, umbilical cord and accompanying materials. In this case, the products of conception are donated by the mother, with the baby being fine. The materials are placed in a sterile container and taken to the nearby FDA registered, certified laboratory right away.
What conditions benefit from their use? In the research literature there are benefits being shown for:
- Arthritis: All Types
- Soft Tissue Conditions: Tendonitis, Bursitis, Ligament Injury (e.g. Achilles, Knee, Rotator Cuff)
- Sports Injuries
- Neurologic Conditions:
- Trigeminal Neuralgia
- Migraines and Cluster Headaches
- Post Herpetic Neuralgia
- Pelvic Pain
- Back Pain
- Lyme Disease
- Plantar Fasciitis
- SI Joint Pain
- Tennis/Golfers Elbow
The list of conditions that benefit from amniotic/umbilical procedures is extensive and continues to grow. With the way these biologics are regulated by the FDA, they may be used for conditions where physicians deem them to be safe and clinically useful. Our disclaimer is consistent: No treatments mentioned here have been evaluated by the FDA. As with any medical treatment, R3 Stem Cell does not guarantee any particular outcome. No treatment protocol or specific biologic indication has been evaluated or approved by the FDA.
What is the difference between stem cell injections and PRP Therapy? PRP stands for platelet rich plasma and involves a simple blood draw from the patient. This blood is placed into a kit and spun quickly for 10-15 minutes in a centrifuge machine. What this does is separate the blood into several layers. The middle layer is termed the “buffy coat” and contains concentrated platelets, white blood cells, and 8-12 growth factors. There are minimal stem cells in PRP, if any. It is a very helpful regenerative biologic but not a regenerative therapy.
Amniotic and umbilical materials are very consistent. When the processing occurs at first rate labs certified by the FDA, the amount of cells are very high and extremely consistent. Unlike adipose and bone marrow, where the cell counts drop big time with aging and the quality of those cells diminishes as well. One thing that should be noted is the MYTH that there are no live cells in processed amniotic fluid. The FDA does not require the material to be radiated, and if a low amount of preservative is used the cells survive the processing. In addition, cryopreservation does not kill cells. (If it did, egg donor programs would go out of business.) So labs that don’t radiate and use minimal preservative get plenty of live cells! There are too many studies to count looking at the effectiveness of amniotic/umbilical tissue to treat musculoskeletal conditions.
Are all amniotic and umbilical cord products the same? The short answer is no. While the actual biologic material from the donor is extremely similar, the processing can vary. All donors are heavily screened for diseases and are under the age of 35. The DNA factors are removed to prevent rejection, making the biologic material immunologically privileged. The main differences occur when the material is processed at the FDA Certified lab. While the FDA is strict about how the materials are processed, there are some significant differences that can take place. For instance, some labs will radiate the biologic which essentially kills all the cells. Others will use a LOT of preservative which will kill all the cells instead of preserving them.
Suffice it to say that not all of these products are the same once processing is complete. So it is critical to receive treatment from an expert provider who is using a quality product.
Why are regenerative procedures so popular? For starters, we don’t harvest from adipose tissue (fat) or bone marrow. Bone marrow derived stem cell procedures require an aspiration from the patient’s iliac crest (pelvis). Studies have shown a 29% incidence of chronic pain from the aspiration procedure along with potential for additional complications such as nerve/vessel injury, bowel perforation, fracture. In addition, as one ages the quantity and quality of stem cells obtainable from the bone marrow drops exponentially. It is illegal in the US to culture one’s bone marrow to amplify cell counts. At birth, 1 in 10,000 cells in one’s bone marrow is a stem cell. This drops to 1 in 2 million by age 70. No matter how much one’s bone marrow is concentrated, the cell counts are a problem.
Adipose derived stem cell procedures require a mini-liposuction from the abdomen or buttock. The first problem with this is that plenty of patients simply do NOT have significant adipose tissue to spare. The second problem with adipose procedures is interesting. Adipose tissue contains VERY HIGH numbers of stem cells. However, once the adipose is processed and moved to your area of treatment, over 80% of them die within two days. So they do not even get a chance to help!
Studies have shown that bone marrow aspiration procedures have a high incidence of complications. Twenty nine percent of patients end up with chronic pain, which is a real problem when the objective is to actually rid patients of pain. Can you imagine that conversation, “Hey doc my knee feels awesome but “WHAT DID YOU DO TO MY HIP?!”
How exactly do these materials work? The father of modern regenerative therapy is Dr. Arnold Caplan, a researcher at Case Western Reserve University. His extensive work has shown that the regenerative materials used are predominantly acting as signals to one’s body, telling the body to “get to work” and repair itself. He actually recommends changing the abbreviation of MSC’s, which normally stands for Mesenchymal Stem Cells, to Medicinal Signaling Cells. The goal is to “more accurately reflect the fact that these cells home in on sites of injury or disease and secrete bioactive factors that are immunomodulatory and trophic (regenerative) meaning that these cells make therapeutic drugs in situ that are medicinal.” He continues, “It is, indeed, the patient’s own site-specific and tissue-specific resident stem cells that construct the new tissue as stimulated by the bioactive factors secreted by the exogenously supplied MSCs.”
For more information on regenerative therapy you can perform a search at pubmed.com and find multiple studies on the subject.
Having healthy cells is not a passive process. Active, regular tuning-up of our cells is not only feasible, but also necessary to slow aging and reduce the risk of cell dysfunction. We are, after all, only as healthy as our cells. Imperceptible cell dysfunction that is not corrected early can lead to disease. Fine-tuning can be done daily in only minutes, using pulsed electromagnetic fields (PEMFs). In addition, when there is a known imbalance (when symptoms are present) or there is a known disease or condition, PEMF treatments, used either alone or along with other therapies, can often help cells rebalance dysfunction faster.
PEMFs work to:
- Reduce pain, inflammation, the effects of stress on the body, and platelet adhesion.
- Improve energy, circulation, blood and tissue oxygenation, sleep quality, blood pressure and cholesterol levels, the uptake of nutrients, cellular detoxification and the ability to regenerate cells.
- Balance the immune system and stimulate RNA and DNA.
- Accelerate repair of bone and soft tissue.
- Relax muscles.
Pulsed electromagnetic field (PEMF) therapy is FDA-approved to fuse bones and has been cleared in certain devices to reduce swelling and joint pain. Transcranial Magnetic Stimulation (TMS) and Magnetic Resonance Imaging (MRI) work on the same physics.
This therapy has been used to treat pain and edema in soft tissue for over 60 years. The technology stemmed from radio frequency (RF) diathermy, which utilized a continuous electromagnetic field to produce heat in soft tissue.
A moving – or resonating – magnetic field can create currents without heating and thus directly alter cellular signaling. It has been firmly established that tissues including blood, muscle, ligaments, bone and cartilage respond to biophysical input, including electrical and electromagnetic fields. New studies show that with the proper field intensity and frequency, treatment with PEMF appears to be disease-modifying. The stimulation provided by PEMF treatments favorably affects cartilage homeostasis.
What sets us apart? In our office we follow up stem cell injections with applications of guided PEMF. We use the Electrons Plus unit so we can guide the electromagnetic wave by hand to specifically treat the area of interest. The thought is that if we are regenerating tissue, lets charge the treated area with guided PEMF to create the healthiest tissue possible.