Helping to Sort Hype from Reality in Knee Stem Cell Arthritis Treatments
We’re seeing an explosion in physicians using stem cells for problems such as knee arthritis from small private clinics to university orthopedic and pain management departments. On the one hand, as the physicians with the most experience in the country using stem cells for orthopedic problems like knee arthritis, it’s helpful to have that company. In addition, as advocates for responsible physician stem cell use, we love seeing more patients have access to this therapy. The good news is that a few selected physicians are doing high quality work, the bad news is that the vast majority are not. How can you tell the difference? Are there questions you can ask to tell the real deal from someone who likely doesn’t know what they’re doing? Here are seven disturbing trends of stem cell hype and the requisite patient questions that go with them:
1. The Fat Stem Cell Two-step-The number one stem cell arthritis problem we see out there is passing off a century old procedure (a fat graft) as a stem cell procedure. There is a fat stem cell procedure that involves digestion of the fat (usually with an enzyme known as collagenase), but it’s been declared an illegal drug by the FDA. Many physicians are ignoring the FDA’s prohibition on fat stem cells or just don’t know there is one. While the research on whether this procedure helps knee arthritis is in it’s infancy, some enterprising doctors have tried to get around the regulatory issues by avoiding the digestion step. The only issue? If you don’t release the stem cells from the matrix in the fat through digestion or other means, you don’t get any viable stem cells. Some doctors believe that by buying inexpensive mechanical emulsifiers that make the fat look visibly like a liquid that this will release stem cells. We’ve tested the best of these in our advanced lab and there are no stem cells released by this method. How can you tell if you’re falling victim to this bait and switch? Pricing is usually a start. The collagenase digestion agent, if it were purchased as an FDA approved medical grade product would run $2,000-$3,000 for the doctor to purchase. If you use research grade collagenase on human tissue, that costs at least $300-400. Hence a $1,000-$2,000 fat stem cell procedure is either not a stem cell procedure (i.e. no viable stem cells) or the fat has been digested with cheap reagents that have never been tested nor approved for human use. How can you tell if you getting the fat stem switcheroo? Ask these questions: “Do you use an enzyme to digest the fat? (they should be using collagenase)” Also realize that while you’re asking that question, if they do use an enzyme the FDA has declared that the production of is illegal, it is an unapproved drug in the U.S.
2. Trust Me I’m an Expert-In medicine, there’s a pretty fixed definition of an expert. The doctor has been performing a procedure for a long-time, has copious experience (usually thousands of procedures under his/her belt), has published original peer reviewed research, published book chapters on the topic, and has taught other physicians. While most of the physicians who have been using stem cells for several years or longer can’t fill all of these criteria, they at least have experience. So they’re not experts, but experienced. However, we’re seeing a rash of physicians who have taken weekend courses and have declared themselves experts! Why is this an issue? We see these “experts” making copious mistakes like using anesthetics that kill stem cells or not understanding how stem cells should be handled or harvested. How can you determine if the doctor is a real expert of just pretending to be one? Ask these questions: “How many years have you been using stem cells? “Be careful with this question as many physicians will substitute the years performing platelet rich plasma so that you can’t learn that they just began injecting stem cells a few months ago. “Can you send me copies of original stem cell research papers where your physician is listed as an author?”
3. I Have No Idea What I’m Injecting-The first rule of using anything in patients is having a sense of dose. For stem cells, various counts can be used. However, believe it or not, 90% of the physicians now using stem cells in orthopedics have no counts on which to gauge dose. The machines they use can’t do this nor do they have any lab equipment nor knowledge about how you would get to a cell count. That means that they have no idea whether they have enough stem cells for one joint or two, or to treat any specific disease. In addition, on what are they basing the lowest minimum dose? Meaning we recently found a stem cell dosing threshold for our specific knee arthritis procedure, but this wouldn’t apply to any other clinic’s procedure (outside of our network). Without knowing the dose of stem cells, they have also never had any data on which to judge the effectiveness of their stem cell harvest (i.e. does it produce a lot of cells or are they doing it wrong and it produces few cells). You can avoid this issue by asking some simple questions, “Do you count the number of cells in the sample?, “What’s the mean number of cells per cc of tissue your harvest?”. If the clinic can’t answer these questions, you’re in trouble.
4. I Have No Idea that What I’m Injecting Likely Has Viable Cells-If you don’t know how many cells you’re injecting, you can bet you also have no idea that the techniques you use actually produce living stem cells (a.k.a. “viable”). How hard could that be? Well, the most commonly used local anesthetics in orthopedics will kill stem cells dead. In addition, if you don’t harvest the cells correctly, you won’t get viable stem cells. For example, to this day, most bone marrow bedside stem cell machines used by physicians teach doctors to draw a single site of 60 cc of bone marrow aspirate, despite research being available since 1998 that showed this was a surefire way to guarantee a poor stem cell yield. Where you draw your stem cells from also matters. In addition, the processing techniques themselves may be killing cells. There’s a laundry list of common mistakes that can kill or reduce viable stem cells. The only way to know that what you’re doing is correct is to use a procedure that’s been validated to produce good cells. For example, we routinely use cells for research purposes, so we frequently show that our techniques produce viable and living cells in our advanced lab. In addition, the protocols that our network physicians use are validated to produce good cells. Ask these questions, “Can you show me data from your lab or a third party lab where you have tested the cells for viability using your technique?”
5. I Really Have No Idea that I Got the Stem Cells in the Right Spot-So you pay your hard earned money for a discount “stem cell procedure” only to find that the doctor uses a blind harvest and injection technique. Meaning, since he uses no imaging guidance to know where the needles are going, he has no idea whether the stem cells got to the places they needed to go. This is like trying to drive your car with mud on the windshield. Is this happening? I’d estimate that about 2/3’rds of all stem cell harvest procedures and about 1/2 of all stem cell re-injections have no guidance. How do you avoid this issue? Ask this question, “Which type of guidance do you use to harvest and re-inject cells?” There are only really two right answers-fluoroscopy and ultrasound. If they say they use a CT Scanner, this will work, but you’re getting exposed to 100X or more more radiation than other x-ray techniques. If they say they don’t use any, that’s not good.
6. I Treat Everything-If you treat arthritis, why not treat ALS, MS, ED, COPD, or any other combination of letters that are associated with sick patients? As I’ve always said, treating just orthopedic conditions with stem cells is a huge task, treating everything is a sure sign of a problem. The doctor may be well intentioned, but as my mother used to say, “Jack of all trades, master of none”. So how do you sort out knee arthritis stem cell hype from reality when just injecting a knee can be quite complex. Does the meniscus or ACL need cells? If so, how will you be able to guarantee that this is where the cells went? How will you control the chemical micro-environment inside the knee before and after the cells go in? Should you use a biologic scaffold and if so, what? How much activity should be allowed and when? Should a brace be used? This is just for a knee! As you might imagine, treating everything from ALS to MS to knees means that many of the answers to these questions are being guessed, rather than carefully studied. There are no real questions to ask here, as most clinics wear this badge on their sleeve (i.e. web-site).
7. I Have No Idea Whether What I Offer Works-Perhaps the biggest issue that we see that directly and concretely impacts patients is the lack of data collection and reporting. As an example, for many common fat stem cell treatments, not a single research publication exists showing that this stem cell type helps the condition in question. Clinics will often get around this by throwing a bunch of research articles on their web-sites, none of which actually have anything to do with what they’re doing. When it comes to figuring out if stem cells work for something like knee arthritis or M.S., type of cell matters as does how that cell is processed, handled, and injected as well as where that cell is injected. Change any one of these parameters and a research paper that looks like it’s describing what the physician is doing becomes invalid in determining if the therapy that physician is offering is effective. Look for outcome data on the specific cell type being used, processed in the same way, handled in that way, and injected in that way. I will tell you that after looking at many of these web-sites offering knee arthritis stem cell treatments, almost all of them have not collected nor published any data that what they do is effective. Despite this, many appear to have research posted on their web-site, so be careful! What are questions to ask? “Please forward me peer reviewed or on-line published clinical outcome data for my specific condition using the same exact technique you plan to use (i.e same exact cell source, same exact processing, same exact harvest, reinjection, and handling techniques were used).” “If there are any differences in the technique that you use from the research you supply, compare and contrast those techniques.” If they can’t send you anything or if there’s an obvious mismatch, then this is a problem.
The upshot? Hopefully you can avoid wasting time, energy, and money on hype. Just follow these seven simple steps to sort stem cell hype from reality and copy/paste these questions and you’ll be fine!