BUYER BEWARE: What You Should Know about Biologics Clinics

Cell based treatments have earned a well-deserved place in modern surgery and medicine. When experts like me first introduced cell and molecular based technology to orthopedics, we were met everywhere with resistance. It was a big struggle, but we believed in the molecular science and the technology behind the treatment.

From the very beginning, we kept detailed, validated outcomes analyses on all of our patients. That gave us the critical information we needed to determine who the best candidate for this treatment was. Our approach was slow, methodical and in the best interest of our patients, the vast majority of whom had an excellent clinical response.

We have since seen an explosion of clinics ‘adding on’ cell based therapies in the past five years and have been not only underwhelmed but concerned for the potential for patient exploitation. Cell based treatments aren’t for everyone, and you may be most appropriate for surgery or a joint replacement – and we’ll tell you that if it’s what we think. In the event you decide you want to get further information by visiting one of these clinics, consider the following or risk spending a lot of money on a poor investment:

  1. Be wary of marketing companies that are disguised as biologics clinics. These clinics are usually staffed by primary care docs who claim to be sports medicine experts. They may or may not have one year of training in primary care sports medicine. This isn’t the same as an orthopedic sports medicine fellowship. There are lots of wanna-be clinics claiming to be experts in ‘orthopedic stem cell therapy’, even though they have no orthopedic training at all. Ask them where they learned about cell based treatments, what textbooks and journals they get and look to for what’s really on the cutting edge.
  2. Demand at least one opinion from an expertly trained and experienced orthopedic surgeon. Orthopedic surgeons are the best trained and have the surgical skills demanded to provide the best cell delivery through the least invasive means with the least complications. Regenerative orthopedic surgeons are the best possible providers for this type of care because they understand the natural history of bone and joint disease. We have indicated people for joint replacements, performed many joint replacements and followed patients for years after their surgical procedures.
  3. Find out exactly who owns and runs the clinic. Is it a surgeon dedicated to the field, or is it a few businessmen backed by big money investors?
  4. Ask how the provider follows their patients. Because of the costs and availability of the cell based treatments, the selection bias is all but prohibitive in putting together real scientific data for interpretation in this setting.
  5. Find out how the provider decides who is and who is not a candidate for the procedures.
  6. Find out where they get the cells from. Insist on a detailed explanation and demonstration of what exactly is done. Often the provider will give away how unfamiliar they are with the techniques when you start asking questions at this point. The FDA has continued to frown on the use of fat for many reasons. Fat fractions don’t contain the same types of cells as the bone marrow. These missing cells in the fat procedures may limit tissue healing as well as the inflammatory/immunomodulatory response. If a clinic only offers fat – run the other way.
  7. Ask the clinic how they count cells and what their average number of cells delivered is. If they can’t answer this or don’t count cells, run away. We have an on-site lab where we count cells on every patient who has the procedure.
  8. Ask the clinic what other research they are doing. We sample our cell product at four different times during the procedure and obtain an enzyme linked immunosorbent assay (ELISA) to determine what the concentrations are of the molecules that we believe are responsible for the clinical effects that are achieved.
  9. Do they use any advanced imaging? We use MRI with a cartilage protocol and 3D mapping not only to determine the specifics of the disease state but to compare with future studies that will provide objective data on the results of our procedures. We are the only clinic that offers this in the nation.
  10. Ask what kind of image guidance they use for cell injection. If they don’t use any, run the other way. The best and most experienced surgeons will use ultrasound (no radiation). Some may use fluoroscopic techniques because that’s all they have. While fluoroscopy does unnecessarily expose patients to radiation, it’s a small amount and having fluoroscopy guidance is better than nothing.
  11. Do they use any advanced technology for diagnosis and treatment of joint disorders? We use an in-office micro arthroscopy device that is a 2.2mm camera in a needle. This device allows us to simply insert a small needle into the knee that has a built in camera. The device allows us to visualize the site of the pathology directly on a video screen. Once the site has been identified, a port on the device allows the direct injection of cells into the target. This precision delivery of cells can be extremely important for meniscal and rotator cuff injuries.
  12. Ask the provider for a detailed explanation of how the procedure works. While this is common knowledge to immunologists and rheumatologists, you may find that your cell salesman has no clue. They often simply say, “We don’t know”. Well, actually we do. There is a molecular and celluar basis for every process in the human body, including arthritis. While once written off as ‘wear and tear’, it’s become obvious that it is a biochemical and biophysical process and we have deciphered a great deal of the ‘code’.
  13. Beware the ‘used car’ cell salesman. Where did the provider train? Ask about the number of cases the provider has done, which type and what complications have been observed.
  14. Know what you are getting yourself into. Cell based treatments are expensive and a big investment in your health. We have treated enough patients over the past eight years to feel like we really know who will benefit the most from the treatments. After meeting with the provider the first time, do your own research online from peer reviewed sources like orthopedic journals, not a marketing company website trying to sell you on their project.

Speaking of selling, I’ll close with the following article that lays out the harm and absolute devastation caused by bogus biologics clinics claiming expertise in stem cell treatment. Beware buyer:

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