A New Orthopedic Stem Cell Clinic Grading System
POSTED ON 12/29/2016 IN Research BY Christopher Centeno
Since Regenexx is the industry leader, we feel the need to establish guidelines for stem cell clinic quality and transparency. Because the technology is new and there are low barriers to entry, it's the stem cell clinic wild west out there, which leaves patients confused about how to ensure the best shot at maximizing their odds for recovery. Hence this morning I'm announcing a stem cell clinic rating tool .
As an example, I recently got pinged on Twitter by a clinic calling itself Stem Cell Professionals in York, PA. This was a brand new clinic to me, so I checked out their website to see what they are doing. At first, it all looked impressive, but when I checked under the covers, once again, there was little there. This gave me the idea for this new tool.
The Orthopedic Stem Cell Clinic Quality Tool
The tool uses six categories that will become clear below. The focus is to determine if the clinic is operating at a low level, an "OK" level, or a high level. Let's dig further.
Regenexx uses only advanced imaging guidance. This means that our doctors are trained to be able to inject specific structures in joints rather than to just perform simple joint injections with ultrasound. If you want to understand these differences, watch this short video.
If the clinic we're evaluating uses no guidance and only injects blind (meaning they can't even confirm they're in the joint), then they get a poor rating. If the clinic uses ultrasound or fluoroscopy imaging to accomplish only simple joint injections but has not been certified by the Interventional Orthopedics Foundation in higher-level and more advanced procedures, they get a fair rating. If they can perform the whole spectrum of advanced procedures, they get a good stem cell clinic rating.
In the case of Stem Cell Professionals, from the information available, the provider performs simple joint injections, so they get a fair rating.
Regenexx uses whichever high-dose biologic fits best with your condition. So that may be high-dose platelet rich plasma (HD-PRP) or high-dose bone marrow concentrate (a same-day stem cell procedure or HD-BMC). We can also use cells that have been grown in culture (through a licensed site in Grand Cayman).
If the clinic uses a dead cell product, like amniotic “stem cells” or “cord blood” (see our testing on these products), and is billing these as a stem cell procedure, this is consumer fraud, so they get a poor ranking. If they use a bedside machine to create a same-day stem cell injectate from bone marrow or use fat as a primary source of stem cells, they get a fair ranking. If they use high-dose bone marrow concentrate (on average at least 100–200 million total nucleated cells per cc), which currently can only be obtained by processing in a lab by hand and using a proprietary protocol, then they get a good stem cell clinic rating.
In the case of Stem Cell Professionals, their website clearly advertises that they provide stem cell treatments, but they are delivering a dead cell, amniotic, product, so they get a poor rating.
The Regenexx network uses only MD or DO physicians who have extensive experience in image-guided procedures and a solid, nonsurgical musculoskeletal background. So as an example, an orthopedic surgeon wouldn't generally (there are exceptions) have the skills to place needles under imaging guidance. A family doctor with no other training might be able to learn simple ultrasound-guided procedures, but has no background in musculoskeletal medicine.
So if the doctor is a non-musculoskeletal provider or the clinic uses a nurse practitioner, physician's assistant, or naturopath, the clinic gets a poor rating here. If he or she is a musculoskeletal-trained physician, but one we wouldn't normally accept on the Regenexx network due to lack of training in advanced injection skills using guidance, he or she is placed in the fair category. Finally, if the provider is someone we would consider as trained enough to be part of our network (even if they're not part of Regenexx), they get a good ranking.
In the case of Stem Cell Professionals, they have a nurse and a doctor, so I focused on the physician. The doctor is listed as working there, but additional web research showed that she also works at a local family-physician clinic, an urgent-care clinic, and an aesthetics clinic. Her training is in emergency medicine.
Since she has no musculoskeletal focus for her training, she was given a poor rating.
Advanced interventional orthopedics needs an appropriate site for the procedure to happen. Ideally, this is a dedicated procedure room that has all of the things one would find at an outpatient surgery center (procedure-specific tables, ultrasound, fluoroscopy, a crash cart, an automated defibrillator, medications, sterilizers for equipment, access to medical providers with ACLS training, etc.).
If the procedure takes place in an office not designed to handle procedures, that has very little of the above equipment (like a chiropractic or acupuncturist's office), then it is rated poor. If the procedure takes place in a medical office that doesn't have many of these tools but does have a dedicated medical staff (like an orthopedist's office), then it is rated fair. If the procedure takes place in an outpatient ambulatory surgery center or an office equipped as discussed above, it receives a good ranking.
Stem Cell Professionals is a chiropractic office, so it gets a poor stem cell clinic rating.
Regenexx has collected, via a nonprofit registry, more outcome and side-effect data on stem-cell-treated orthopedic patients than any other clinic worldwide. We have always placed this data online. Now we have an outcome data tool that places all of our data online on a monthly basis as it's collected. Patients can slice and dice this information as they like. This is ALL of the data for patients opting in, including patients who did well and patients who did poorly.
If the stem cell procedure we're comparing has no available online data, it is placed in the poor category. This includes those that place data online that has nothing to do with the procedure they perform (a bait and switch). If there is some data, it is placed in the fair category. If the clinic places all of its data online for patients to dissect, it is placed in the good category.
This clinic has no published online or other data. In fact, it seems to be a copy-and-paste website similar to those being sold by the chiropractic practice management group hawking amniotic stem cells that I featured a few months back. Hence, it gets a poor rating.
Regenexx has published more outcome data (based on the number of patient results reported) on orthopedic stem cell use than any other provider worldwide. We continually publish several papers a year on our patented and proprietary procedures.
If the procedure we're evaluating has no publications (bait-and-switch publications as discussed above don't count), then it is placed in the poor category. If there are one or two, then it is placed in the fair category. If there are extensive publications of efficacy and safety, then it is placed in the good category.
There is no published data on the use of dead amniotic tissue to help knee arthritis and certainly not on the product being used by this clinic, so they get a poor stem cell clinic rating.
The upshot? I hope this new stem cell clinic rating tool helps patients get a sense of what they're getting. While we can't guarantee that we can help every patient, we can try to stack the deck in our patients' favor by delivering the highest quality care possible!
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