We see it listed all over billboards, talked about in the news, discussed on podcasts and social media, but as a patient, how do you navigate the industry of regenerative medicine / stem cell therapy, and is it something that would work for you? I am fortunate enough to work in the healthcare industry and have access to information that most patients do not, and when it comes to regenerative medicine, not all treatments or practices are the same.
I want to help those who have injuries navigate these waters and be able to get a treatment that actually works and doesn't just waste time and money.
My personal experience:
I was road biking one day and while going at a fairly fast pace my left outside knee got really tight and i heard and felt a massive “pop”. I ended up tearing my LCL. Now let me preface this story by saying I’m not a fan of needles or knives, therefore as someone who wanted to avoid surgery at all costs (which is what I was originally told would be kneeded (pun intended) to treat my injury), I decided to forego treatment altogether. Instead I altered my lifestyle over the next couple years by avoiding running, biking, and leg day at the gym, etc.…..not the ideal situation nor recommended. I was fortunate enough to work at Gulfcoast Ultrasound Institute, an ultrasound school which offers regenerative medicine training programs for doctors and other medical providers that specialize in musculoskeletal injuries (ie. Sports Medicine, Orthopedics, Pain Management, Rhuematologists, Military Doctors, etc.). Because of this, I began learning more and more about the various regenerative medicine/stem cell therapy procedures available, that if done PROPERLY, could not only alleviate my pain and weakness, but actually repair the ligament without the pain, time away from work, and recovery process that surgery would require. Needless to say, I was eager to see if a Regenerative Medicine procedure would get me back to the lifestyle I had missed so much. I had an ultrasound exam done, and it confirmed I was a candidate for Platelet Rich Plasma (PRP) treatment(s). On the ultrasound, you could see where the ligament was torn and because I put off treatment so long both ends of the tear had calcified. While the thought of a needle wasn't great, I knew it could be a promising alternative to surgery and help me get my life back.
Dr. Craig Chappell, of In2it Medical (based in Pleasant Grove, Utah) explained the procedure and what to expect then performed my PRP (I will explain PRP below) treatment using ultrasound imaging to accurately guide the needle and make sure the injury was appropriately treated. To my surprise, the procedure was not all that painful, it was a bit uncomfortable but not what I was envisioning in my head. Before injecting with PRP, he numbed the area, then stabbed the calcified areas a number of times to break it up (fenestration), he then injected the PRP solution and completely saturated the area (he could see all of this happening in real time by using ultrasound to assist in this procedure). He told me no anti-inflammatory medications for a week and that I would be seeing the effects by 6 weeks. The next day I was VERY sore but was told to use it as much as I could bear and each day thereafter it got progressively better. At first it didn't feel any different than before, however, three weeks after the injection, I definitely noticed less day to day pain. Six weeks post procedure it felt as if I never had the injury! I started running again, added in squats to my workouts, as well as more intense stretching. It has been over a year at this point and the only time I ever have a hint of that injury is if i don't run for more than a week at a time. As long as I keep it moving and stay active, I have zero pain and full mobility! Please note i am NOT a runner, when i say running i mean maybe a mile at a time or even extended walks do the trick.
Since then I have had about a dozen friends and family members get PRP treatments by Dr. Chappell, all of which have had great results with injuries ranging from knees, elbows, tendinosis, thumbs, shoulders, toes, and ankles,. Needless to say i am a big advocate for regenerative medicine/Stem Cell procedures!
Ok, into the Nitty Gritty:
First off, what are the different “Regenerative Medicine/Stem Cell” procedures being offered and what should you look for in a doctor?
The most popular types of Regenerative Medicine therapies being offered to patients are Prolotherapy, PRP (Platelet Rich Plasma), and Stem Cell therapy harvested from either Lipoaspirate (Fat), Bone Marrow, and Amniotic Cells.
With ALL of these procedures available, the most important thing to remember is to do your homework and research a reputable practice that specializes in these procedures. They might be the best Sports Medicine or Orthopedic Surgeon in your area, but regenerative medicine is a whole different science, and they may or may not have sufficient training, experience, or the equipment to perform these procedures. Also, do your research on the type of regenerative medicine treatment your doctor recommends as it relates to your specific injury and the recommended number of treatments, statistical outcomes, etc that are indicated in published studies.
. Lastly, ask your medical provider if they are using Ultrasound guidance when they perform these treatments! A practitioner that truly knows what they are doing will utilize ultrasound. First as a diagnostic tool, and secondly as a tool to guide their instruments and the biologics/medicine during the procedure. If your provider says they dont use ultrasound, walk away or at least seek a second opinion (I will explain this below).
Unfortunately, with the rise in popularity of these “billboard” procedures (and the fact that most insurance companies do not pay for them so they are “Self-Pay” procedures) there are FAR too many offices out there that are taking advantage of this additional revenue source and will recommend a treatment but may not have the training, knowledge or skills to give you the results that these procedures really ARE capable of giving patients (when done properly). Then, you find yourself in the position where you end up needing to have the doctor perform that surgery you were trying to avoid in the first place. What they may have not told you in the beginning is that different types and degrees of injuries should dictate which type of regenerative procedure is appropriate, and that your injury may require multiple treatments for you to receive the full benefits of the procedures.
Below, I am going to describe these Regenerative Medicine procedures (using terminology that the average patient would understand). These procedures are also in the order of what is generally used for least to most severe injuries treated. They key basis behind the science of regenerative medicine/stem cell therapy is that these procedures revolve around the body’s natural inflammatory response. When you get hurt, your body sends cells to that area to naturally signal healing. So in theory, if you can have a higher concentration of these cells around that specific injury, it will actually increase your inflammatory response (swelling), but will actually decrease healing time, regenerate the damaged tissues and have you back in action sooner. The key is determining how severe your injury is and which therapy would work best for you.
What is it: Prolotherapy, which is essentially sugar water, is usually step one in injury treatment and is also the cheapest option. Even though it is the most basic treatment in this arena, I have also seen it used on a severe case of TMJ and had really great results stopping the “clicking” and reducing chronic migraines! Did you know that sugar is so inflammatory it can be used to signal this response? This is also why people that eat a lot of sugar are prone to joint pain, bloatedness, and general discomfort… you eat / drink sugar your whole body can become inflamed. With Prolotherapy they are basically injecting a sugar based substance directly into your injured area causing the inflammation and signaling your body to send cells to start the repair process.
Pre--Treatment: NO Anti Inflammatory medications 4 days prior to treatment (Tylenol is ok if needed) Post Procedure: NO anti inflammatory medications 1 week after. Ice is NOT recommended. Avoid water activities for 3 days (Tylenol is ok if needed) Healing Time: Varies by injury type but generally speaking, even though you may be sore, you should still use the treated area. NO strenuous weight training exercises for 1 week.You will feel the effects in 6-8 weeks if this procedure has worked. Multiple treatments are sometimes needed.
Platelet Rich Plasma (PRP):
What is it: PRP is using your body's own blood cells to supercharge the healing process. Once you are determined to be a candidate, you will go into the office and they will draw your blood into a few vials. These vials are then placed in a centrifuge which causes the red and white cells to separate and concentrate. The practitioner then injects the concentrated healing cells directly in and around the injured area supercharging the healing process. Depending on the injury, you may require multiple PRP treatments to fully heal the injury, which is something you should always discuss with your doctor up front so you can be fully informed on what to expect throughout this process. Remember, in this treatment process inflammation is good!
Pre--Treatment: NO Anti Inflammatory medications 4 days prior to treatment (Tylenol is ok if needed) Post Procedure: NO anti inflammatory medications 1 week after. Ice is NOT recommended. Avoid water activities for 3 days (Tylenol is ok if needed) Healing Time: Even though you may be sore, you should still use the treated area. NO Weight bearing exercises for 1 week.You will probably notice a slight difference in 3 weeks but should will not be fully healed until 6+ Weeks. Multiple treatments are sometimes needed. It is normal to experience soreness at the injection sites and you may experience an increase in pain and soreness after the numbing wears off for about 2-5 days after your procedure. The initial inflammatory phase lasts 7 days and the second phase can last up to 14 days.
Lipoaspirate (Fat derived Stem Cells):
What is it: One area of your body that contains a very high concentration of healing cells is in our fat. Studies have shown that fat derived stem cells can regenerate tissues along with other benefits (even at a higher degree than PRP (blood). During lipoaspirate procedures, the doctor will use a harvesting needle and remove some fat cells from your body. It is then processed to concentrate these healing cells which are re-injected into the injured area. This procedure much pe performed in a sterile enviroment, therefore the costs of this treatment are higher. This treatment is usually reserved for more severe injuries that require higher concentration on stem cells to heal the injury..
Pre--Treatment: NO Anti Inflammatory medications 4 days prior to treatment (Tylenol is ok if needed) Post Procedure: NO anti inflammatory medications 1 week after. Ice is NOT recommended. Avoid water activities for 3 days (Tylenol is ok if needed) Healing Time: Even though you may be sore, you should still use the treated area to avoid stiffness. NO strenuous weight bearing exercises for 1 week.You will notice a difference at 4+ weeks. It is normal to experience soreness at the injection sites and you may experience an increase in pain and soreness after the numbing wears off for about 2-5 days after your procedure. The initial inflammatory phase lasts 7 days and the second phase can last up to 14 days.
Bone Marrow Derived Stem Cells:
What is it: Bone marrow is chocked full of healing regenerative stem cells, unfortunately to get these they have to puncture a hole using a large needle usually into your pelvis and extract the bone marrow.The bone marrow is then processed to derive the concentrated stem cells which are injected into the injury site. This procedure must also be performed in a sterile enviroment and is the most invasive of the procedure. While this doesn't sound fun it could still be a great option for patients with severe pain / injury or who may not be a surgical candidate due to various health restrictions, age, etc. or athletes that need a faster recovery process (and the recovery is still MUCH better than surgery). Thought the cost for this treatment is higher than others, these cells are rich and can be very beneficial when done correctly.
Pre-Treatment: NO Anti Inflammatory medications 4 days prior to treatment Post Procedure: you will be observed for a period of time (about 30 min) after the procedure before being released. NO anti inflammatory medications 1 week after. Ice is NOT recommended (Tylenol is ok). If they have a compression bandage on, post procedure leave it there for at least 2 hours.Leave the bandage over the bone marrow harvest site for at least 3 days Healing Time: Even though you may be sore, you should still use the treated area. NO Strenuous weight bearing exercises for 1 week.You will notice a difference in 4+ weeks but should will not be fully healed until 6+ Weeks.
Amniotic Stem Cells: I am placing this at the bottom not because its more invasive but because it’s typically more expensive than the rest. I also do not have experience with amniotic so I can't speak to its effectiveness.
What is it: Amniotic stem cells are derived from fluids normally discarded during planned caesarean section births (babies or mothers are not hurt during this process). The cells are processed, concentrated, and stored to be used in various situations from musculoskeletal injury to burns, etc. There are many suppliers of these types of cells out there and not all of them are high quality. If you decide to go this route, research the supplier and determine for yourself if this is a legitimate source. Personally i would rather start treatments using my own cells rather than someone else's. The idea behind amniotic cells is that they come from the freshest cells a human can produce, full of growth factors and designed to develop a baby. The idea is that these cells can help supplement and regenerate the injured area of someone older. There is a constant debate on the use of these cells and if they do what they claim. Trials and studies are conducted using the best of the best but that doesn’t mean the doctor you are seeing is using those same cells.
Pre-Treatment: NO Anti Inflammatory medications 3 days to a week prior to treatment Healing Time: There are claims that a difference can be felt the day after while some say 2 weeks others say 6, there is a lot of different information out there and it is hard to decipher which is accurate. Post Procedure: NO anti inflammatory medications 1 week after.
You are probably thinking why is this guy all about ultrasound? Let me explain ultrasound first and why it is important. Ultrasound uses sound waves (no radiation) and sends those waves out of a transducer and into the body. The sound waves are reflected back and processed by the machine to form an image. Not only are you not getting radiation, it also allows your doctor to visualize all structures from Bone, ligament, tendon, nerve bundles, blood vessels, and organs. If you say “hey doc, it hurts when I do this” they can use ultrasound and see exactly what is happening when you get pain.
“My doctor told me they use fluoro”. That's fine, and fluoroscopy does have some beneficial uses and I don’t want to discredit those using fluoro in their practice. The issue is fluoroscopy creates a continuous moving X-Ray Image, so yes, they can see inside and see the needle for regenerative medicine procedures however, the patient is being exposed to a constant stream of radiation during that time. All I am saying is why expose yourself to radiation if you can get the same if not better results using ultrasound. Some advanced practitioners do say fluoro is the preferred method for some spinal work but still, you cannot visualize blood flow. I would trust this rationale by a provider IF they also extensively use ultrasound at their practice.
Going in “Blind” or “palpation method”
“I was told we don’t need ultrasound at this practice since they have done so many”... Really?! In my opinion there is no excuse to not use ultrasound in a practice! The equipment is affordable and training readily available. Telling a patient they don't use ultrasound is an excuse not to learn a new skill. Have you ever looked at an anatomy book, have you seen how many nerves, veins, arteries, and other vital structures there are in a body? Did you know that not all people have their vessels, nerves, and other vitals in the same locations? Why would you risk injecting someone “blind” when you can take a small bedside machine, show your patient what you are seeing, boost the patient satisfaction by showing them what the injury looks like, put on color flow and visually see where vessels and nerves are so you can avoid them, and use that skill to direct your needle exactly where it needs to go and verify placement of the cells?
The Wild West
While I have had a great experience with regenerative medicine, there are many people out there that have spent thousands of dollars on multiple treatments after hearing false promises by clinicians either using bad products, or who just don’t have the proper skill set to perform these treatments. We live in an age with incredible advancements in technology that are enabling us to heal in record times by avoiding invasive surgeries, it really is truly amazing! The issue is weeding through the crap and scams and making educated decisions. There is currently not a required certification process for healthcare providers to prove competency in performing regenerative medicine procedures so it is up to us as patients to put in the research and find out who is legitimate and can properly perform these treatments. As a patient, don’t be afraid to ask your physician about their training in these procedures, what treatment and imaging methods they use, which biologics/products are used for their treatments, and what a realistic treatment plan and recovery time will look like should you make this investment in your health with them! Any regenerative medicine practitioner should be able to provide you with answers to all of those questions along with clinical studies/evidence that support their treatment plan for you. Regenerative Medicine procedures have the ability to work minimally invasive wonders on your body, just be sure to do your research and make an educated decision on your treatment(s)!
There are currently a number of practices out there doing “free luncheons” where they tell prospective patients the benefits of stem cells, and wouldn't you like to be pain free without surgery promises. Some of these are legitimate, but there are also some sketchy ones. I have personally been to these lunch’s looking for physicians I could recommend in my area. The rooms are filled with people ready to have their pain cured from torn ligaments to arthritis, fractures, etc. Everyone has their lunch served and the presenter starts by asking who has had pain? Of course...hands go up.
The presenter and their team put on a flashy presentation and give very broad answers on what stem cells are and all the benefits. Naturally we all think our injuries are special and questions come up such as “will this help my knee that's been replaced 3 times”, “I fell out of a tree when I was 7 and broke my thumb now I’m 64, will this fix me?” “ OF COURSE IT WILL!” Claims the presenter! They go on to provide some true statistics plus a heap of enhanced data and information but usually count on people's attention dropping when they hit the technical data.
Don't just take the presenters word for it, let’s hear from past patients! They usually bring in a number of older “patients” to put on a show of their physical capabilities after being treated with stem cells and making claims such as “I was able to practically run up the stairs pain free after 1 week”... Who would have guessed that some of these are paid to be there...GASP!? Also, the reason I am calling them “presenters” is often times the doctor doing the presentation is not actually performing the procedure, nor are they clinically active, they are basically the spokesperson for the whole deal.
They then get everyone to sign up for free consultations and once they get you alone in the office, they might breeze past prolotherapy, prp, lipoaspirate and bone marrow as treatments and offer you something even better... It’s super rare, and can cure any ailment, guaranteed to work and only $3, 000 - $10,000! What a steal!
Say you go for it, and after 6 weeks you see no difference, the practice will offer you a discount for another injection of this magic solution, and most likely that doesn't work either. Now you are left with a bad taste in your mouth thinking that all regenerative medicine procedures are garbage.
The “Blind” Bait and Switch
Let’s say you get injured. You go to your primary care or emergency room who sends you for an X-ray, CT Scan, or MRI then refers you to a sports medicine or orthopaedic facility. You go into the facility and see signs for “stem cells”, “regenerative medicine”, “avoid surgery”, etc. You go back to your private room and meet the healthcare provider. They feel around the injured area a bit and they tell you, “you tore this, you broke that”, and surgery may be your only option HOWEVER, we could try regenerative medicine first, which has really promising results and could allow you to avoid surgery altogether!
Here’s the scoop guys. Regenerative medicine procedures are NOT currently covered by most insurance, so you will be paying cash. Say they offer you a procedure anywhere from $700-$7000 cash. This is the point you need to be educated and do your research! Here are some “double dipping” situations that do actually occur:
The facility knows the patient is not a candidate for regenerative medicine yet does it anyways knowing they will need surgery in the end. The facility does “blind” regenerative medicine injections knowing there is a moderate fail rate versus under ultrasound guidance and will most likely need surgery in the end.The facility does a proper regenerative medicine treatment yet tells the patient they will be pain free in 2-3 week and if they still have pain, surgery is the only option and doesn't give the treatment time to actually work.
How do I avoid these tricksters?
As a patient in this day and age, you have to do your research. We have a wealth of knowledge at our fingertips and we can’t expect our healthcare providers to do everything for us, those days are gone. You have to take responsibility and go into treatments like these fully educated on what to expect. Ask questions, ultimately you are the one paying for it. Like I mentioned before, I would always prefer trying the least invasive procedures first or using my own cells however, do your research and go with what you are comfortable with.
Things to ask:
What type of Regen Med procedures are you doing? (prolotherapy, PRP, Lipoaspirate, Bone Marrow, Amniotic)? Price: Do your research on what pricing for each treatment should roughly be in your area. Prolotherapy is the cheapest followed by PRP, then the more invasive treatments.
Do you use ultrasound for diagnosis/ procedure guidance? (if they say no...red flag) How many procedures have you performed? Where did you learn how to do these procedures? When will I notice a difference (if they say under 2-3 weeks... red flag) Pre and Post procedure recommendations? (if they don't tell you no anti inflammatories...red flag)