Top 10 Questions to Ask about Your Orthopedic Stem Cell Therapy
Thinking of getting your knee, hip, ankle, or shoulder arthritis treated with stem cells? I’ve been asked by patients for years, what questions should I ask to vet providers that offer stem cell treatments for arthritis? How do I know I’m getting a legitimate stem cell therapy that might help? How do I know the doctor knows how to perform the stem cell procedure? Is it safe? Does it work? How much is known? Is the lab processing done right? How much experience does the clinic have? Here’s the top 10 questions to ask orthopedic stem cell clinics (most of these questions apply to any type of stem cell therapy being offered):
1. Experience is Everything in Medicine. Studies of various complex medical procedures have shown that the more experience a surgeon or physician has with a procedure, the better the results and the lower the complications. A stem cell based procedure to treat arthritis is no different. Ask the clinic, how long they been using stem cells to treat arthritis. Be a bit careful as some clinics will quote the length of time (or number of procedures) they have been treating patients with PRP (platelet rich plasma) and not stem cells. Also ask how many stem cell procedures the clinic has performed. In most medical procedures, competency happens somewhere after 20-50 procedures, expertise happens somewhere north of several hundred.
2. Where’s the data? While stem cell treatments for arthritis are new, investigational care data should be collected by the provider at all times. This goes beyond a simple phone call after the procedure. Instead this registry tracking should be in the form of a pain/function and complications questionnaire before the procedure and after at set time points. Ask if the clinic has reported this data somewhere. In addition, investigaional care must be part of a registry, meaning that some organization is tracking your treatment results and possible complications. Why? I have been asked by various patients to look at the results of some very nasty outcomes from stem cell therapy. While bad complications can happen with any invasive procedure, that data at some point needs to be reviewed by the physician’s colleagues to ensure that the procedure is safe. At the very least the physician should be reviewing this data. How can you review the data if you don’t collect it? Are there any scientific publications on this particular stem cell technique? Be careful, as many clinics will “borrow” other studies or results that aren’t an apples to apples comparison with what they’re doing. If they don’t yet have large amounts of data, where can you read about both their stem cell successes and failures? The clinic should post information on both it’s superstar patients and those who didn’t respond.
3. Physician specialty matters. I’ve been asked for years by my female patients who are receiving Botox injections to treat their dystonia if I would perform their routine cosmetic Botox. Since I’m not a cosmetic dermatologist or plastic surgeon, this never made sense. Therefore, why would you want your untrained plastic surgeon or family doctor performing a complex stem cell procedure on your knee, hip, shoulder, or ankle? Medical specialties exist for a reason, greater training means better results. Expect that a physician performing a stem cell injection in your knee, hip, shoulder, or ankle have board certification in a specialty with training in injection based care into joints: sports medicine, physical medicine, interventional pain, or orthopedics. You can check any physician’s board certification by going to the American Board of Medical Specialties web-site.
4. Cell source is important. The location where the stem cells are harvested is critically important to the outcome of the procedure. You would accept at face value that if you gave someone a blood transfusion with the wrong blood type that bad things may happen. Stem cells used to treat knees, hips, shoulders, and ankles can be obtained from the many sources, the most common being blood, bone marrow, and fat. While there are circulating stem cells in the blood that can be used to help repair orthopedic tissues, this is the least plentiful source. If you have a smaller arthritis issue or a soft-tissue injury like a partial rotator cuff tear, these cells combined with platelets may help. The next two most common sources where there are lots of stem cells are bone marrow and fat. While adipose tissue contains many stem cells, they’re generally not the right type of stem cells to do things like help heal cartilage and bone. This leaves bone marrow as the most appropriate source with fat being an adjunct source. Ask this important question-Do you take cells from both bone marrow and fat? If they answer yes, then at least you know they could use either or both. If the clinic answers that they’ve only ever been trained to harvest fat and have never used bone marrow cells, look elsewhere as this is not an orthopedic focused clinic. As a caution, we see plastic surgery and age management/aesthetics practices beginning to inject stem cells to treat orthopedic problems. These clinics only offer fat because they aren’t trained to perform a bone marrow aspiration while they do know how to perform liposuction. Don’t let the physician’s comfort with a certain stem cell harvest procedure drive the treatment choices.
5. Harvesting Technique is Critical. One of things we learned early on was that how stem cells are harvested dramtically impacts their viability. As an example, a physician performing a bone marrow aspiration blind (without some sort of guidance where he or she can see the needle), will frequently be in the wrong spot and draw blood containing less stem cells rather than marrow which contains more. As another example, a physician drawing a larger volume of marrow aspirate from just one site will end up with fewer stem cells than a physician drawing smaller amounts from multiple sites. Ask if the clinic uses imaging guidance (either fluoroscopy or ultrasound) to draw the cells. Ask the clinic if they use a cell biology lab to validate their technique. This means that they have checked to make sure their harvest technique in their hands actually produces viable stem cells (not the technique of the guy that taught them in a weekend course). Ask how they know how many cells they have. If a physician is using a bedside centrifuge that spins down bone marrow, there’s no way to know what’s in the sample as the machine doesn’t report that number. Ask if they have a lab on-site capable of counting the cells or culturing samples to make sure the physician performing the stem cell harvest is taking good samples.
6. Is the Cell Processing Technique Validated in their Lab? After the tissue containing stem cells is harvested, it’s often processed to enrich or purify a certain fraction of the tissue that contains the most stem cells. The cells may also be cultured to achieve a greater number of cells. While we’ve seen an explosion of physician stem cell processing bone marrow and fat in everything from bedside centrifuges to shaker kits to simple in office hoods, all of these physicians are following a set script for processing. How does the physician know that this processing technique produces viable stem cells in his hands? Have samples of the stem cells produced in the physician’s office been sent out for verification and testing? First, can the cells be cultured to produce more stem cells? Second, have sophisticated lab machines like flow cytometry (a machine that can identify a stem cell from a blood cell) ever been used to validate that the technique in his or her hands really produces stem cells? Don’t rely on the report that someone else did this verification (usually the company selling the kit to the doctor), but make sure the clinic has done it’s own verification that when they use the kit they were sold, they get stem cells.
7. Getting the Stem Cells to the right spot. If how you get the stem cells out and how you process them once you have them are important, an equally critical step is how the stem cells are put back into the arthritic knee, hip, shoulder, or ankle. Blind injections in the office without imaging guidance using fluoroscopy or ultrasound are destined to have a significant miss rate. Meaning a certain amount of the time the stem cells will be injected someplace other than their target in the joint. Cell placement in joints also goes beyond simply placing cells inside the joint, but into the specific damaged area of the joint. Ask if fluoroscopy or ultrasound imaging will be used to place stem cell back into the joint. Since some places of the joint can be more accurately accessed with fluoroscopy and others with ultrasound, ask if the clinic has both available.
8. Some common medications and additives can kill stem cells. A common medication used by physicians to numb up an area is a local anesthetic. This medication can be injected inside a joint with cells or before cells to make the joint injection hurt less. However, these common anesthetics, even at very low concentrations, also kill stem cells. This gets back to #6, how do you know your technique of re-implanting cells isn’t killing the cells? Questions to ask include: does the doctor use anesthetics that come in contact with the stem cells and if so has the doctor validated (either in his lab or an outside lab) that this won’t harm the cells. The clinic should have also tested how long the cells will survive after they leave the processing area and before they are injected and if additives used in the procedure will hurt this type of stem cells. If the doctor only has a bedside centrifuge or machine to process cells or a hood in an exam room, don’t expect that these tests have been done, as they can’t be performed in this type of setting and require a more sophisticated cell biology lab. Again, the focus should be on if this clinic has tested these things in their hands, not that some company selling them the kit tested these things.
9. Level of Lab Sophistication Matters. Most doctors performing orthopedic stem cell therapies have either bought a bedside centrifuge that produces a fraction rich in stem cells, are using a kit they bought to process cells, or have a biologic safety cabinet (a clean hood) where they process cells. These are in contrast to a much more sophisticated and dedicated cell biology facility. If the doctor doesn’t have a cell biology lab and instead uses a kit at the bedside, the first question to ask is if they’re using a “closed” system or an “open” system to process cells. A closed system means that from the time the cells taken from the body until the time they are re-injected, the cells never touch the outside environment. Most “shaker” kits being sold to physicians in the U.S. to process adipose (fat) stem cells are open systems, which risk contamination. If the system to process cells is open (meaning the cells are being transferred from one container to the another in any significant time frame) then the cell processing has to take place at a minimum in a clean hood which is HEPA filtered. This will reduce contamination. Even better is a dedicated cell biology lab, which is more sophisticated than placing a hood in a patient room. This set-up provides multiple layers layers of protection. These would include sterilization of gloves of the person processing the cells, protective gear, and additional air quality checks and sterility checks in the facility. Ask under what level of lab sophistication your cells will be processed. If they processed in a closed system or in a clean hood, you’re better off than if the doctor is using a kit at the bedside or in the back room.
10. Avoid hype. Stem cells are body parts that can assist in healing tissue, not magic. Any clinic that tells you that you can expect to have your arthritis pain helped 100% of the time is not being truthful. Stem cell injection procedures or surgeries performed using stem cells have a success and failure rate no different than any other procedure. The quality of stem cells varies from patient to patient just as some patients heal well after surgery and others will not. Ask what the sucess rate is for the stem cell procedure. If the response is thoughtful and measured and based on the severity of your condition then you may be in the right place. If the response on the other hand is that you can expect to be healed no matter what you have wrong with you, then run. Ask if the clinic will provide a candidacy grade like good, fair, or poor. Ask what these grades are based on. Every honest clinic using stem cells should be able to tell you if the procedure is a good fit or a bad fit. If the clinic seems to have as it’s only candidacy criteria whether your credit card clears, run.
I hope these questions help patients vet the quality of orthopedic stem cell therapy.