As you know, I often write about what I experience on a day-by-day basis. Today’s blog topic comes from a back-and-forth on LinkedIn. These past few years, we’ve seen some physicians ditch the limited bedside machines and open their own minilabs in their offices. A few have bought videos on how to make platelet-rich plasma, bone marrow concentrate, or fat products and cite the video as to how they had the expertise to open a small processing lab. However, from my direct experience, few of these video watchers actually have all of the mechanisms in place to protect patients. Hence, I’d like to walk you through the difference between the DIY (do it yourself) lab and what we do at Regenexx.
At Regenexx, we offer what we call a “Flexible Lab Platform.” Why? After all, most physicians use a simple, one size fits all, bedside centrifuge. We consider that the training wheels of regenerative medicine. Hence, once you become an expert in regenerative medicine, you lose the training wheels and graduate to an in-house lab. As discussed above, most labs out there are DIY. They have a simple hood to process samples and a few pieces of lab equipment, but as I’ll show you, many of these don’t do the myriad of things you need to keep patients safe. In the meantime, to learn about what we do at Regenexx and why, see my video below:
The first major difference is obvious. In a DIY lab, what you have are old protocols for isolating platelets or the stem cell fraction in bone marrow or any number of other processes. They were pulled from published papers. The problem is that none are state of the art. So the processes being used in a DIY lab are secondhand and thirdhand goods.
The protocols we use in the Regenexx Flexible Lab Platform are the subject of constant research by our lab research team. Meaning, we add new protocols all the time to make new things, like a fat-processing procedure that’s regulatory compliant but maximizes free stem cell yield or a new method of concentrating an antibreakdown molecule, like A2M. In addition, we constantly add improvements to maximize the effectiveness of our existing protocols. For example, maximizing the amount of growth factors used in our platelet lysate procedure (now on its fourth generation).
In summary, a DIY lab uses old protocols, while at Regenexx, we’re constantly updating our science.
I would now like to walk through all of the differences between a clinic watching some videos and opening a lab (DIY) and what we do at Regenexx to ensure patient safety. in fact, we are just in the midst of upping our game yet again, so a few items listed are in the process of being implemented. However, it won’t be hard to see the stark differences.
The biggest issue is how well you can train a processor to isolate samples in the lab. Obviously, all you get in that regard with a DIY lab is a video. So is this enough? Let’s look at everything we do at Regenexx to train processors:
Written and video training protocols—This is similar to what you get with a DIY video, but read on.
Hands-on training for the processor—This is critical, as you can watch all of the videos in the world on a complex topic like processing cells, but unless you get hands-on training, you can never know if you’ve mastered the process or are just doing it wrong over and over again.
Written testing—All of our processors must pass a written test on what they do.
Ongoing CME for processors—There is a reason we doctors are often required to show proof of continuing medical education, as medical knowledge isn’t stagnant and is evolving all the time. In addition, it’s proof that once a subject is learned, it stays learned. Hence, our processors are required to participate in ongoing education to refine, hone, and test their skills.
Ongoing assessment of processor competency—As you know, there is “book learning” and then there’s actual testing that you can do something in the real world. Hence, we test the competency of our processors on an ongoing basis.
Ongoing in-vitro testing of lab output to test processor competency—OK, there’s book learning, and then showing you can do it in the real world, and then there’s actually producing the products that get injected and making sure these are within the desired specifications.
Protecting patients is critical, but, regrettably, none of that is monitored in a DIY lab. You’re trusting that the doctor supervising the lab is monitoring all of this stuff, but, frankly, from what I have seen, most don’t even know that these safety issues must be addressed. Let’s take a look at what we do at Regenexx.
Cleaning the hood—This sounds like a simple issue, but how you clean the hood and making sure that this is done between every patient sample processed is critical.
One patient sample at a time—Again, this is a simple mantra that we always preach, as it reduces the likelihood of cross-contamination between samples. Meaning, only one patient’s injectates are prepared in a given hood at any given time.
Proper PPE—To protect the patient and the employee, proper personal protective equipment (PPE) must be worn. This is a hat, mask, sterile gloves, and sterile disposable sleeves.
Sample mix-ups—What processes are in place to ensure that each patient only gets back his or her sample and not another patient’s? We use multiple steps, from sterile bags with the patient’s ID to only allowing one person’s samples in a hood at a time to multiple checks on the injection end.
Ongoing surface contamination testing—You can do all the cleaning you want, but you must be able to test to ensure that the surfaces used for processing are periodically monitored to make sure that they’re sterile. We use two different types of testing to ensure this is the case.
Validation of all equipment in need of same at appropriate time points—This one sounds a bit complex, but it’s actually simple. Take, for example, a sterile hood. This is used to make sure that processing the sample is done in the highest quality clean-air environment possible. However, unless the hood is validated on an annual basis to take particulates out of the air, it may not be functioning as advertised.
Product deviation reporting—When processing real patient samples, everyone is slightly different. These deviations from the norm need to be reported and reviewed to ensure the processor is doing the best work possible, even when the sample provided isn’t the best.
Annual on-site lab audit by an experienced best-practices lab processor—An instructor-level processor visits each site on an annual basis to ensure that the network processor is maintaining the high standards we expect.
What the processors do and how they should do it is determined by standard operating procedure (SOP) documents. DIY labs can buy these, but again, these are not static documents. In addition, the DIY labs often have far too few of them to properly run a lab. In addition, they have no mechanisms to ensure that all of their employees who work in the lab actually understand the SOPs. At Regenexx, we take care of all of that guesswork.
While this seems simple, the refrigerator where you store samples needs to be tightly temperature controlled. As an example, when is the last time you went to grab something out of a fridge and what was supposed to be just cold was actually a bit frozen? That can’t happen with living human cell samples, as freezing without a cryoprotectant kills cells. Hence, we use medical refrigerators that closely monitor internal temperature at 4C. DIY labs often use an off-the-shelf fridge you can buy at the appliance store.
The upshot? Be careful of DIY labs, as we’re seeing more of them. While an on-site lab can maximize the quality and customizability of patient samples, it’s also something that is incredibly complex to run correctly. In fact, if run in a sloppy manner, the lab presents a huge risk to patient safety and their wallet. Why the wallet? The patient has no way to ensure that what’s coming out of that lab is what was promised. At Regenexx, as you can see, we go to great lengths to protect patient health and make sure that what they get is what we said they would get.
About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…