Regenerative Biologics Injection Therapy
Introduction: This topic goes by several names. As with any emerging field of knowledge and specialization, it is a work in progress. The new terminology seems to be headed toward using the phrase Regenerative Biologics Injection Therapy. It has previously been called one or more of the following: Prolotherapy, Regenerative Injection Therapy (RIT), PRP for platelet rich plasma injections, and Stem Cell Therapy when stems cells were injected. Essentially, it is about using a variety of biologically active substances to stimulate and enhance an individual's natural healing response and capacity. New, more effective biological solutions are being identified and made available to practitioners. Since these substances are 'naturally-occurring' they do not fit the current Big Pharma controlled medical-industrial economic model and system. This has led to a variety of what are, in my humble opinion, obstruction to the progress of this emerging healing modality.
The subject of regenerative medicine has exploded over the past decade. It is one of the most exciting topics in all of medicine today and it is showing promise of ushering in a new age of treatments that actually stimulates the regeneration of healthy new tissues that can 'fix' a host of issues, from various joint & sports injures (where it's already being used regularly), to chronic diseases that up until now were thought to be untreatable.
This science is still in relative infancy in the United States primarily due to FDA regulations on what can and cannot be done once the substances are harvested (more on that later). Sadly, the FDA is controlled by Big Pharma, this has been well-documented elsewhere, and as such, has a vested interest in protecting the status quo of the medical pharmaceutical cartel that also controls the entire field of medicine.
Over the years I have been involved in, and extremely impressed with the results and benefits of what we previously called Regenerative Injection Therapy (which included Prolotherapy, PRP, & Stem Cell injections). The new name being used due to various 'censoring' activities on both mainstream media and social media is 'Biologics Injection Therapy,' although I prefer 'Regenerative Biologics Injection Therapy.' From my experiences with thousands of patients, I became and remain convinced that this is the medicine of the future, and it is available NOW. This has the potential to be a bigger game changer than things like the discovery of antibiotics, once again, that is just in my opinion.
Speaking as both a physician and a patient, Ive witnessed first-hand the effects of what successful treatments can do for joint and soft tissue damage; and that was mostly using the older, standard prolotherapy solutions. Ive seen it help numerous patients who had been told that there was nothing else to try except a major surgical procedure that may work or could make them worse. Most of these people had resigned themselves to a life of chronic pain, inactivity, pain medications, and/or having to consider major surgery as their only other option (and a few who did go ahead with surgery with disappointing results).
It is important to understand that the older solutions used in Prolotherapy, PRP, and Stem cell injections DID work quite well. Using the newer refinements associated with 'biologics' helps take it to a new level in terms of the types of injuries and other conditions that can be helped. Prolotherapy already had a 90+% success rate when done properly. One of the biggest problems with prolotherapy was that there were very few well-trained practitioners. First, the doctor should have a solid foundation in musculoskeletal injuries, manual medical procedures, proper training in prolotherapy, and a good mentor to help them learn the procedures. It is vital to be able to do a good, hands-on examination of the musculoskeletal system and have well-developed palpation skills. You have to be able to properly diagnose the problem and identify the damaged structures. It is crucial to know the proper needle placement, applying solution to all f they key spots for that joint problem. It is also important to support the patient nutritionally so that their body is able to muster a strong healing response.
PRP and Stems provided similar results although they became popular and attracted many practitioners that did not have the proper training that only years of doing prolotherapy can provide. Those two, stronger solutions allowed the doctors to be somewhat sloppier in their technique and still get good results although the price tag was several times higher than for standard prolotherapy.
In the world of sports, biologics injection therapy, i.e., prolotherapy, PRP, or stem cells injections is one of the major advancements that has allowed athletes to have longer, healthier careers. In the NFL alone, many players from Chris Johnson to Prince Amukamara to Peyton Manning have undergone this treatment. Tiger Woods has been a patient for his knees. Major League baseball pitchers like Los Angeles Angles pitchers Garret Richards and Andrew Heaney have opted for this treatment plan instead of undergoing the traditional Tommy John surgery to repair damaged elbow ligaments. One prominent Midwestern physician who has performed many such procedures, mostly for high school and college pitchers (five of whom ended up in the major league), noted that, while he was selective about the patients he chose, only one of his patients ended up needing Tommy John surgery. I personally used prolotherapy on a major league pitcher over 20 years ago that extended his pitching career by several years without having Tommy John surgery.
Athletes know that their 'job performance' revolves around their bodies working well. Their tools are their arms, legs, torso, hands, and feet, they are like a carpenter's saw, drill, hammer, and screwdriver. For a pro athlete, any 'tool' in his/her kit that doesn't function well means an inability or diminished ability to work, which may mean forfeiting thousands or even millions of dollars. Most pro athletes today are well educated on the avoidance of popping anti-inflammatories and taking multiple steroid shots to stay active, having seen the toll these actions have taken on their unfortunate predecessors. Regenerative medicine procedures such as biologics injection therapy are a major reason we now see so many pro athletes playing competitively into their 30s and 40s.
Biologics injections are a huge source of hope and healing for those with chronic sports or other injuries, so why is there so much negative attention and even controversy surrounding these approaches in the last few years? There are a few reasons but the most crucial one is that it doesn't support the current medical-industrial model that is focused on medications and expensive surgical procedures. Think about the revenue lost to orthopedic surgeons and hospitals for every surgery that is not needed because some simple injections stimulated the body to heal itself.
There are several different Biologics/Biological Treatment Substances from various sources.
Here's a quick checklist of some of the most common substances used in biologics injections:
Dextrose & Lidocaineare the basic components of standard prolotherapy. Although prolotherapy may not technically be considered to be a 'biologics injection procedure' by some, it is in my book. It is the granddaddy of all regenerative injection therapies and STILL works extremely well. The concentrated dextrose solution simply acts as an osmotic irritant that activates the body's natural healing cascade of controlled inflammation and collagen repair. It is still one of the best choices when someone isn't in a major rush, or the damage isn't too severe. When either of those factors are involved, that is when it is worth taking a serious look at adding a more powerful biologic solution. *Note, for anyone that is concerned about using dextrose for whatever reason, there are alternative solutions.
PRP - Platelet Rich Plasmawas the first biologic used in place of the standard prolotherapy solutions. It works well and can often stimulate the healing rate 2 or more times than the basic dextrose solution. The downside is that it is significantly more expensive, requires a blood draw, processing of the blood, and reinjecting it. The actual injection procedure is typically much more uncomfortable (painful) than treating the same area with the standard prolotherapy solution.
Autologous (i.e., coming from one's own body) regenerative tissues were typically taken from the bone marrow or adipose (fat) cells.Since they come from an individual and are 'processed' and then reinjected into the same individual there is no risk of rejection by the body, however, the procedure to harvest bone marrow or fat cells is a bit tricky, expensive, a bit painful, and risky. Drilling a hole into bone, typically the pelvis, to get bone marrow, and making an incision in the abdomen to macerate, or 'mash up' adipose cells, in effect a mini liposuction, can cause pain, bleeding, and even serious infection given the degree of bone and soft tissue penetration. And, let's face it, many of the individuals that these procedures are being done on aren't in tip top shape like the pro athletes mentioned earlier.
Additionally, it's well-documented that the stem cells sought in doing such procedures drop severely in number as we age. A study by AI Caplan et. al. showed that the percentage of mesenchymal stem cells, or MSCs to bone marrow cells, drops from around 1 in 10,000 at birth, to 1 in 100,000 by the teenage years, to as low as 1 in 400,000 by age 50 and 1 in 1,000,000 by age 70. While some physicians have claimed to be able to boost this number in older patients by selective exercises and a nutrition program, the concern still exists that you're going through a long, uncomfortable ordeal without much yield to show for it.
Umbilical cord regenerative cells & substances.Some of the most well-known biologics today are those that come from the umbilical cord (the tube attached to a baby's navel that provides oxygen, food, a blood supply, and waste removal up until birth). Properly screened mothers are able to donate their umbilical cords for medical purposes that would otherwise be thrown away or destroyed. The umbilical cord contains several valuable substances that are being used at the cutting edge of regenerative medicine today.
- Wharton's jelly this makes up much of the substance, or tissue, of the umbilical cord that provides most of the support around the blood supply (umbilical artery), and yes, it looks like clear jelly. This is composed of a multitude of 'scaffolding' proteins (which provide an 'anchor' or network for the other injected substances to stick to and not drain away), growth factors, chemical messengers, and in some cases (depending on the preparation) live stem cells that can stimulate your body's own healing factors to repair damaged tissue. One of the best things about using these cells, nutrients, and growth factors is that they pose no legal or ethical issues. They are not fetal; they are from the mother and would have been discarded if not used.
- Umbilical cord blood: this is one of the newer biologics available, and it contains a variety of different cells, which, like the Wharton’s jelly products noted above, contain a bounty of growth factors. Additionally, the blood forming cells within the cord blood have the ability to develop into a variety of more specialized cells in line with what is needed for recovery and healing in the damaged area.
- Exosomes: these are tiny vesicles that “bud” off from live cells, that are the newest exciting frontier in regenerative medicine. Exosomes are composed of messenger-RNA (mRNA, which sends a “code” to the host’s cells to begin repair), micro-RNA (which helps to regulate mRNA and has anti-inflammatory properties), cytokines (small proteins that act as messengers for cell-to-cell signaling that can, among other things, strengthen the immune system, carry growth factors, and provide instructions from one cell or cells to others). Because of their small size, they can cross the blood-brain barrier, and have higher concentrations of growth factors than adult stem cells.
- Placental products. Another treatment option (or one that can be used in conjunction with the biologics given above) consists of what is known as placental products (i.e., from the placenta, the “birth sac” that houses and protects a developing baby, that is harvested after birth. These products have biologic growth factors and cellular components from sources such as placental tissue that are derived from stem cells. These growth factors, much like those found in PRP (fibroblast or epidermal or transforming growth factor) as well as other elements are useful in tissue healing, like collagen, laminin, fibronectin, hyaluronic acid, etc. Hyaluronic acid is extremely important as the “lubricant” in the joint spaces; it’s “thick” enough to resist pressure as a shock absorber, and works with the other substances to collectively provide a strong anti-inflammatory effect (i.e., less pain). Like umbilical cord biologics products, these substances can provide excellent healing benefits.
When to Consider Biological Injections Therapy vs regular Prolotherapy?
As you might guess, there’s no single, easy way to answer that question. Most people who come in seeking biologics injection therapy have joints or body parts that are severely degenerated, and they’ve usually seen several specialists after being on the typical rest, pain medication, steroid injection, more pain medication cycle. Many have even tried other forms of regenerative medicine such as Prolotherapy or PRP with limited success; it is always challenging to know the true reason the prior treatments failed, in many cases I suspect it was due to a relatively inexperienced practitioner with poor technique. Generally, both Prolotherapy and PRP have very high success rates, but there are wide variations in a practitioner’s skill level and the patient’s healing response. Others have undergone surgery, only to find that the operation did not get rid of their pain; unfortunately this is not that unusual since surgery does NOT address or fix the damaged fibro-osseous junctions between either ligaments and bone or tendons and bone.
Another group of patients are athletes, either competitive or recreational (which may also be quite competitive) whose physical demands on their bodies are high and want the best option available to heal and get back to their sport or activities in general. With these individuals, I always do my best to consider whether adding biological regenerative solutions might be a reasonable option for them to consider. Over my 45+ years of clinical experience, I’ve seen miraculous effects of a combination of manual medicine, nutritional support, and standard prolotherapy, however, full healing takes time and biological regenerative solutions can dramatically speed up the process and may be justified for a number of reasons.
For example, a recreational runner with mild to moderate pain and degeneration in the patellar tendon might be just fine with a prolotherapy or PRP injection series, but a Spartan Race or Tough Mudder competitor who trains nearly year-round (and has the joint wear and tear to prove it) might indeed be a candidate for a stronger biological regenerative cocktail. Another situation that might fit this category is a gentleman in his 60s who loves alpine skiing at a high level—an activity that’s hard enough on the body when you’re younger, let alone in your seventh decade —adding a stronger biological regenerative injection therapy to his knees might be just what is needed to give him another several years at this sport.
Age, as you might imagine, is a factor in the decision as to whether to add more potent biologics such as one containing stem cells. While standard prolotherapy and PRP injections can attract the body’s own local stem cells (pericytes) to enhance the healing process, these diminish in quantity and quality as we age as discussed previously. Chronic inflammation of a joint can, and will, deplete & wear these cells out. Another issue is the joint being treated – some joints (e.g., hips) tend to need a more robust treatment plan than other joints that on average tend to heal faster and better. Hip joints are also more difficult to treat thoroughly, and many doctors have not mastered needle placement at the depth required to touch the hip ligament structures properly.
A “typical” biologics regenerative injection patient tends to be either someone that has suffered a severe injury and has not fully recovered despite a lengthy rehab process and all the standard treatments, or someone with a chronic, nagging joint issue whether due to a known trauma or wear and tear. The most common areas are the low back (actually the sacral-iliac area is the most common, but most people and doctors refer to it as their low back), knees, shoulders, and necks. These are common sites of sprain injuries which are simply abnormal or excessive stretching of the supporting ligaments. The shoulder is the exception where the main damage is primarily to the tendons. Damage to these connective tissues rarely heals back to 100% strength, typically it only achieves 50-75% of the preinjury strength. Anyway, these injuries lead to an increase in the joint’s normal ‘play’ or movement when the joint is used under load. Often, despite throwing everything and the kitchen sink at the injury to fix it, the pain, instability, and reduced function continue. Physical therapy, massage, chiropractic, acupuncture, steroid injections, rhizotomy (elective burning of joint nerve ending), etc.—nothing worked.
While there are some patients who are not, medically speaking, good candidates for this treatment, I have been amazed at the improvement that this treatment plan can provide in pain reduction and increased function in what at first glance seems like a “hopeless” case. If a person has significant co-morbid medical issues they need and can potentially benefit from various regenerative biologics even more, however, I typically recommend a program to enhance their overall health, circulation, energy, and nutritional status first to maximize their chances of deriving maximal benefits from the procedure(s).
Is Regenerative Biologics Injection Therapy for Everyone?
NO, each patient must be properly evaluated to help advise them as to whether this procedure is worth the extra cost over basic prolotherapy for them or not. There are only a couple of circumstances where it may not be advisable although even those cases must be considered individually based on the potential benefit to risks.
Most would assume that a contraindication would be active or recently active cancer or possibly in cases of chronic infection. However, if a patient knows the odds, has no absolute contraindications to treatment, and is willing to follow the protocol, as a rule, I believe that they should be given the choice for an increased chance or recovery. No physician is ethically justified in denying a patient treatment that has a potential to help them. It is their body, their health, and their choice. I just want to make sure that it is an informed choice and that moving forward has at least a reasonable chance of success. For example, although one of the above conditions would seem to be a contraindication, what if they have no other reasonable options? Are they to be denied a chance at prolonging their life and risking a complication? Stems could, and should, enhance their immune system’s functioning (along with the right nutritional interventions) so why not let them make an informed decision? We simply can’t say at this point whether stem cell or other biologics might not be helpful in such situations.
Some doctors who are utilizing new and controversial therapies and procedures “cherry pick” the best or ideal candidates for those therapies, in this case regenerative biologic treatment, thereby skewing the data to make it look like the treatment helps the highest percentage of patients. That may look good in an advertisement or a clinical trial, but it means that they are likely excluding people that this could be their last hope of getting out of life-altering pain or disability. For a man or woman with chronic low back pain that they rate as an 8 out of 10 in severity (i.e., so bad you don’t want to move and it’s hard to focus on anything besides the pain), a treatment that may lower one’s pain level to 3-4 can feel just shy of miraculous. It can literally give them their life back!
I’ve seen hundreds of patients where this was the case with a thorough series of standard prolotherapy treatments. Adding regenerative biological solutions to the prolotherapy procedure supercharges it thereby allowing for faster and more complete healing. In my experience, prolotherapy works over 95% of the time but it typically takes 4-6+ sessions spaced out 1-3 weeks apart. That means that the process can take several months. Adding regenerative biological solutions to the procedure can cut the time by one half to two-thirds.
One patient of a colleague who was suffering from chronic pain in his feet put it this way: “You’re the quarterback of your team in the championship game, you’re down by 4 points with 6 seconds left to play, and you’re 30 yards from the end zone. The opponent’s defensive end is about to sack you, but your receiver running towards the end zone isn’t clear of his defender. Do you throw the ball in the hope your receiver will make the grab, or take the sack and lose for sure?”
One of the most dominant athletes in his sport of all time, Michael Jordan, put it slightly differently:
“You miss 100% of the shots you don’t take.” i.e., you can’t score if you don’t take the shot.
Here are some select examples of real patients who underwent Regenerative Biologics Injection Therapy
CASE #1 – BIOLOGICS INJECTION THERAPY FOR HIP PAIN
Brenda K. was in her mid-50s and suffered from severe left hip pain, which had gotten worse with inactivity and the weight gain that resulted from it. She was using a cane to help her get around and had pain with every step. She did not want to have a hip replacement and did not want to be stuck on a regimen of heavy-duty pain medications for the rest of her life. She was ready and willing to do what was physically necessary to avoid surgery and limit her pain. After being properly informed she decided that if stem cell therapy could help her at least somewhat, she was all in.
On examination, she had severe hip pain that radiated to her groin, pain with weight bearing on her affected (left) leg, a very limited range of motion, plus a flare up of discomfort when her leg was internally rotated. Her X-ray, not surprisingly, looked awful. Where a normal hip shows a “ball and socket” configuration with the head of the femur (ball) and the acetabulum (socket), Brenda’s joint looked like a ball that had smashed into its socket doing 90 mph, there was zero space left.
There was bony growth all around the head of the femur and the acetabulum, and no joint space between the two to speak of. In truth, this was one of those cases where I was second-guessing myself as to whether or not I did the right thing by attempting this procedure instead of referring her to an orthopedic surgeon.
Brenda received an injection of 2 milliliters of cellular Wharton’s jelly with 1 milliliter of amniotic tissue into her hip and the surrounding support ligaments. Six weeks later she came back, per our protocol, for a booster prolotherapy injection to keep the regenerative process & fibroblast production moving along. After a period of rest, she began a gentle home exercise program and physical therapy. When I saw her a few weeks later, she reported with a smile that most of her pain was gone. She still had a slight limp, but was able to get around without a cane, and while her hip range of motion remained limited, there was no pain when it reached its end range, even when I applied extra pressure.
Several months later Brenda reported that her hip pain was “nowhere near what it was before” and as a result of her increased ability to ambulate and exercise she had lost 75 lbs. since her last visit!
At about 2 1⁄2 years after her injections, she reported that her hip pain is a 0 on the pain scale and she hasn’t used her cane since about 3-4 months after her treatments. Whenever I have a case that I’m on the fence about for doing biologics injection therapy with a patient who fully understands the risk that it may not work, I think of cases like Brenda’s and what biologics injection therapy has done for her. How could I not offer this treatment to someone looking for a similar healing miracle?
CASE #2 – BIOLOGICS INJECTION THERAPY FOR KNEE PAIN
Here’s a great example of knee pain in someone that you might not think is a good candidate for Regenerative Biologics Injection Therapy. Nick was an 88-year-old gentleman with a long history of right knee pain and degenerative arthritis. He had a history of having fractured his right kneecap twice, once in childhood and once when in the army, and in his own words, the X-ray of his patellofemoral compartment looked like a dog had chewed on it. Despite the obvious degeneration on his right knee in all compartments, he was an amazingly active gentleman with very few complaints of pain and was in excellent health.
Nick had already received Prolotherapy, PRP, and even PRP with placental tissue to his right knee in the past several times with only limited success. He remained optimistic, however, kept a good weight and active lifestyle for his age, and after explaining the option of stem cell therapy to him he agreed to the procedure. Nick received 2 milliliters of cellular Wharton’s Jelly and 1 milliliter of placental tissue into his knee and surrounding structures. As he lived out of town, contact with him regarding his knee was limited and he was not able to make it back in for the a “booster” injection as ideally recommended. When evaluated him for a different musculoskeletal condition some months later, however, he stated that knee no longer gave him any trouble, and he had not thought it for some time.
Nick’s case is a great example of how you should never judge a book by its cover— just because a patient is elderly doesn’t disqualify them from undergoing stem cell
therapy. Of course, using the newer biologic solutions derived from umbilical cords makes a lot more sense than harvesting one’s own stem cells, and other growth factors, due to the assumed reduced viability of those substances from someone in their 70s or 80s. This even applies to PRP and helps to account for why it works so well in some and not others. All blood is not the same in terms of the health and viability of one’s platelets.
Further, when determining who might be a candidate for Regenerative Biologics Injection Therapy, you need to look at a host of other factors—their weight, diet, overall health, fitness, degree of pathology in the area to be treated, etc.— before telling the patient your best estimate on improving their quality of life. In Nick’s case, both his advanced age and joint arthritis were secondary to his remarkable vigor for an 80-something who had done all the right things with his health prior to his procedure. Without this therapy, his life would have been that much more difficult with the discomfort his knee was giving him.
BIOLOGICS INJECTION THERAPY AND THE FUTURE
In summary, Regenerative Injection Therapy shows great promise as a new, major additional tool in our work to help people overcome their health challenges and achieve their health, performance, and appearance goals.
There are even reports of its use outside the US (where they are not as limited by the medical-industrial complex) for treating spinal cord injury patients, some of whom are regaining motor function in their limbs they thought were gone forever. Even a couple of degenerative nervous system diseases such as ALS (aka Lou Gehrig’s Disease) have shown real promise of providing hope in an otherwise hopeless condition.
The future is truly bright for many people suffering from chronic disease with the advent of biologics procedures... and we’ve just scratched the surface.
Please remember that Regenerative Biologics Injection Therapy is not a ‘miracle’ or a panacea, it is simply another powerful tool that, when used properly, can open up a whole new level of cellular and tissue regeneration by one’s own body.
The body is the only thing that heals the body, our role is to support it and get out of its way. That means starting with a solid foundation and building on it. That solid foundation involves proper diet and nutrition, exercise and activity, proper sleep, rest and relaxation, and properly supporting our circulatory systems.
Very few doctors or people understand that compromised microcirculation is at the heart of virtually all chronic disease processes. When microcirculation is reduced, as it is in the vast majority of the population over about 30-40 years of age, efficient nutrient exchange and waste removal simply can’t take place. This leads to reduced oxygen delivery to the mitochondria and begins a cascade of reduced cellular energy, incomplete maintenance, and repair, and therefore degeneration. And yes, there are effective tools and strategies to correct this problem, it is called EWOT or exercise with oxygen therapy. We offer two of the most recent advancements in EWOT called the Trifecta system (whole body vibration, light therapy, and high-flow oxygen) and PPOT (Peak Performance Oxygen Training) that combines high intensity altitude training with strength, endurance, and flexibility training finishing with high flow oxygen.
A series of EWOT sessions is, in my opinion, one of the best things a person can do to assist their body in overcoming virtually any health challenge. It pairs beautifully with Regenerative Injections Therapy.
Examples of what kinds of conditions Regenerative Injection Therapy can help with include:
- Virtually any musculoskeletal injury or painful condition that has failed to heal properly on its own or is getting worse like osteoarthritis.
- Virtually any chronic disease process where the body is not able to must sufficient healing resources to halt or reverse the process.
- Many aesthetic applications, such as hair regrowth or skin rejuvenation.
- Sexual enjoyment & performance via the Next Gen Penis shot or the Next Gen Vag-O shot.
To learn more about our comprehensive approach to supporting your body to heal and attain your health and performance goals, see our writeups and explanations about the 4Ms.