1. How much experience do you have?
Many studies have been done to evaluate factors that may influence the result of an array of surgical procedures. Almost invariably, when assessed, surgeon experience is an important factor in determining the likelihood of a successful outcome from surgery.
Does that surprise you? Probably not. If you need plumbing fixed in your home, you look for an experienced plumber. Need your taxes done? You look for an experienced tax adviser, but how do you know you know when you’ve found an experienced surgeon?
Surgeons, for most surgical procedures, won’t consider themselves competent until they’ve completed 20-50 procedures. They won’t consider themselves an expert until they’ve done a procedure two hundred times or more.
Procedures that use stem cells are no different. Ask your physician how many stem cell based procedures of the type you need that he or she has completed.
Be aware of chicanery. Physicians at some clinics will talk about the number of procedures they’ve completed that involve PRP (platelet rich plasma) or the total number of surgical procedures they’ve performed (not involving stem cells). Make sure your provider gives you the specific answer for stem cell based treatments.
2. What kind of data do you collect?
Regenerative orthopedic treatments are fairly new: most doctors classify them as “experimental therapies” meaning the techniques are not yet fully understood. This shouldn’t scare you as a patient—after all these years, we still don’t fully understand how aspirin works in the body—but it does mean that the clinic should be collecting data at all times. A simple phone call after the procedure is not enough. Providers should want you to complete a questionnaire after the procedure asking about your pain levels before and after, how well you’re able to use the affected joint now that the procedure is completed, and if you’re having any complications.
Ask the Provider what information they collect and where the information is located on their website. The results should be indexed in a registry, which allows other physicians to review the data and the medical community as a whole to improve its techniques.
Also, ask if there are any publications in medical journals regarding your specific procedure. Keep in mind when asking this question that some unscrupulous clinics “borrow” studies of other procedures that aren’t the same as what they want to do on you. For example they may try using research on bone marrow stem cells instead of the fat stem cells the clinic is actually using. If they don’t have much data for your particular procedure, find out where you can learn about their successes and failures with this procedure. Clinics involved in investigational care should post information about all of their patients from their registry, not just those that responded well to the treatment.
To conclude, it all comes down to one issue. Where is the data this clinic has collected on this specific procedure on their website? Where is the patient infographic that shows results? Where are the publications?
3. Physician specialty matters. As a sports medicine fellowshipped trained orthopedic surgeon, I intimately know musculoskeletal injuries and joint conditions. With this knowledge I know the value of getting patients back to the sport of life without surgical intervention.
There is a reason medical specialties exist. I have thousands of hours of specific training in nonoperative orthopedics, and while I could deliver a baby in an emergency, that’s not my specialty. If something were to go wrong, I would absolutely do the best I can, but I don’t have the specific training that an OB-GYN has. In the same vein, while your plastic surgeon or primary care physician has thousands of hours of specific training in his or her specialty, does this physician have the specific training or experience with orthopedic procedures in general? Or with orthopedic stem cell procedures?
Specific training means better results. If a physician is performing the injection, make sure that he or she has extensive training in guided injections under ultrasound and/or fluoroscopy.
4. What cell source do you use?
Cell source is very important. Stem cells are located in almost every part of our bodies, but not all stem cells are the same. The type of stem cells used to treat knees, hips, shoulders, and ankles can be obtained from several sources—the most common sources are bone marrow and adipose tissue (the layer of fat beneath our * SWITCH skin).
This leaves bone marrow and adipose tissue as possible stem cell sources for joints and tissues that are more degenerated. Adipose stem cells may help in certain orthopedic conditions, but in head-to-head studies with bone marrow stem cells, they are less able to repair joint tissue like cartilage. Bone marrow is the best source for stem cells to be used to help cartilage health.
Let’s talk about “Amniotic stem cells” as they have become a monumental case of widespread consumer fraud. So what’s the problem? The vials of amniotic, placental, or fetal tissues used by clinics offering this type of stem cell treatment don’t contain any living cells. The companies manufacturing these off-the-shelf products are required to actively kill all of the cells with gamma irradiation. Unfortunately that hasn’t stopped unscrupulous clinics from claiming the patient is getting injected with millions of live stem cells.Therefore, any clinic that claims they are using amniotic stem cells to treat orthopedic conditions should be avoided as they may not know their product very well.
When talking with your provider, ask the physician where he or she harvests the stem cells from. If they only take stem cells from fat, then the clinic you are in is either not primarily focused on orthopedic issues or is not staying up to date with the science behind the procedures. There have been some less-reputable clinics that are offering stem cell treatments for orthopedic issues. Keep in mind these clinics only harvest stem cells from fat as they aren’t trained to perform stem cell harvesting from bone marrow or they only use off the shelf “amniotic stem cells”
5. What harvesting technique do you use?
Stem cells are harvested from the body in several different ways and the methods used to harvest these cells are critical to the success of the procedure. Physicians use liposuction to harvest fat stem cells. Bone marrow is the richest source for stem cells that are the most useful for orthopedic issues. Harvesting stem cells from bone marrow requires a technique called bone marrow aspiration.
Bone marrow aspiration is a procedure that requires a great deal of experience. It is very important to actually harvest bone marrow, but this is difficult to accomplish without some form of imaging guidance. If your physician does not use any type of imaging to guide their work (either fluoroscopy or ultrasound), then there is a high risk that he or she will aspirate blood with no stem cells. Also, if a physician only harvests from a one spot (rather than several sites in the bone), the physician runs the risk of getting fewer stem cells, even if he or she does get bone marrow aspirate. I would also like to take a moment to dispel the myth that this procedure is very painful. When in all actuality it is very doable (minimal uncomfortableness)
Additionally make sure you ask if the clinic uses a cell biology lab or has a tool on-site to confirm that it has harvested actual stem cells.
6. Do you count the number of stem cells in the sample?
In stem cell therapy, the issue of whether you’re getting enough cells to maximize the chance of a successful treatment is an epic fail on the part of most clinics.
After stem cells are harvested, they are processed to remove the tissues that aren’t as useful and concentrate the fraction containing stem cells.
I’ve seen several clinics that offer stem cell treatments where the cells are processed in small machines that shake the tissue to isolate a stem cell rich fraction. The majority of clinics that use these machines have no idea how much of what they inject back into you is actually stem cells as they can’t count the cell content of the samples they’re injecting. Are you willing to spend your money on a treatment and gamble as to whether you had enough cells to treat your problems?
7. Are medicines that are detrimental to stem cell therapy?
Steroid injections into joints are very common. Unfortunately when injected in the massive doses that are commonly used, they kill cartilage and other cells. The same way that steroid shots kill all local cells, they will also kill stem cells. Six to twelve weeks of time separating a steroid injection from a stem cell injection is needed. Additionally, if the doctor does more steroid injections than PRP or stem cell injections, you should think about going somewhere else as that provider is sacrificing patient outcome for the convenience of a procedure that is covered by insurance.
Many prescription medications have negative effects on stem cells. I’ve developed a list based on years of observation on which medications make it harder for stem cells to do their job.
8. Do you have a dedicated cell biology lab?
Most clinics do not have an on-site lab, but if they do, not all labs are created equal. A dedicated cell biology lab will have equipment that is absolutely vital to giving you the best possible outcome.
Does the clinic use an “open” or “closed” system? A “closed” system keeps tissue samples inside a clean hood, in a germ-free environment. An “open” system exposes tissue samples to open air, where they are susceptible to being contaminated.
A dedicated cell lab will have a device that allows the doctor to count cells. To ensure your stem cells will be protected from contamination, cell biology labs use air quality checks, sterility checks of clean areas, and protective gear for the technicians.
9. Am I a good candidate?
The best and most successful clinics will have patients who do not respond as well as hoped, and even the most cautious physicians will have patients who develop complications. Unfortunately these things happen in the field of medicine. Physicians will do everything in their power to minimize these risks, but some aspects of patient care are beyond a physician’s control.
If a clinic or physician tells you they have a 100% success rate or close to it they are either lying or rigging the numbers. Remember even the best stem cell clinics have a success and failure rate. Ask your provider what his or her success rate is for your specific procedure. If the answer doesn’t include a discussion of the chances that the procedure will fail, then he or she is not being honest.
Keep in mind that not every patient is not a good candidate. Ask the question, “What percentage of patients have you told that they were a poor candidate for this procedure?” If you get a blank stare, silence or if you believe the only test the physician uses to evaluate you f is your credit rating, get out of that office as fast as you can, and don’t look back.
Knowledge is power and knowing the top 10 questions to ask a stem cell provider can make the difference between a successful and an unsuccessful treatment. Remember there are qualified orthopedic stem cell providers out there, and unqualified ones.These questions will help you find the right stem cell provider to assist you.