Many are familiar with this saying, perhaps stemming from jokes we make as kids. You may not know where the saying comes from, nor its original context. You may also be surprised (as was I) to know that the original phase came from Major League Baseball. In fact, credit for the enduring statement goes to an MLB Hall of Famer, 14-time All-Star and the only player to be named MVP of both the American and National Leagues: none other than the late great Frank Robinson.
Frank knew a thing or two about winning and losing (cause and effect), both as a legendary player and manager. The quote originally appeared in the July 31st, 1973 edition of Time Magazine: “ Close doesn’t count in baseball; close only counts in horseshoes and hand grenades.”
This famous quote leads us to a great question; should “ being close” count when talking about platelet-rich plasma (PRP), and other cellular therapies?
Baseball and Stem Cell Therapy: What’s the Connection?
History aside, what does this saying have to do with cellular therapies? When we advocate and deliver treatment to our patients using autologous therapies like platelet-rich plasma (PRP), bone marrow concentrate (BMC), and, more recently, mico-fragmented fat (MFAT)—is “close” good enough? Over the past 15 years, the delivery of these products has grown exponentially, and it’s one of the reasons why I started a biotech company more than 10 years ago.
This blog is not about who has used or developed these treatments the longest. Rather, it is my concern with the lack of scientific rigor and medical acumen applied to developing these products. While I am not the progenitor of biologics, I can say with certainty that I’ve been treating patients in the US with biologic products since the very early days when it was much less fashionable to do so. I started using tabletop medical devices to make PRP for my patients. In the regenerative industry, this practice continues virtually unchanged today! In all likelihood, 95% of all PRP and BMC used for treatment to date has been produced by technology that is now more than 15 years old.
What Happens When We Make Platelet-Rich Plasma(PRP)?
Therein lies the problem. Let’s use PRP as an example. A patient’s blood sample is processed in a device, and “PRP” comes out the other end. Without a microscope or light scanning device, we can’t actually see platelets or white blood cells with the naked eye. We can get a rough sense of red blood cells through visual observation: for example, whether the product is actually red, amber, or clear yellow defines in decreasing order the rough number of red blood cells (RBCs) present in a sample. The doctor using the device assumes that what comes out is PRP that will help a patient who is hoping for an outcome that will improve their life. In truth, the doc doesn’t know exactly what is in the sample – good, bad or indifferent. If it works, the doctor doesn’t know why, if it doesn’t work, the doctor still doesn’t know why. That simple fact was my call to action fifteen years ago, and that continues to motivate me to this very day.
Ignore for a minute that the field has never defined clearly what makeup of cells, plasma and platelets define “PRP.” Doctors have gotten away with this because many of the patients treated in this fashion do see improvement. For those that don’t have a positive outcome, was it that PRP didn’t work, or did they actually get a proper dose/concentration of PRP? I’ve seen many patients in consultation over the years who tell me PRP didn’t work for their problem. Maybe that is true, maybe it isn’t, but since I didn’t do the initial treatment, I have no idea how they were treated. I do know that it is almost a certainty that their doctor, using a single device to produce PRP, didn’t measure anything in the sample.
Creating a Biotech Company With a Mission; Greyledge Technologies
Now back to Greyledge. Early in my work with PRP, and later Bone Marrow Concentrate or BMC (which is really just PRP made from blood obtained from the bone marrow cavity), I felt it was unacceptable to not know what was in the biologic product that I was putting into my patients. I wanted to know more about the cellular makeup and dose/concentration, thus allowing me to better understand what I was delivering. Close was just not good enough. I wanted to deliver an autologous therapy that gave patients the best chance for a positive outcome, a proper return on their investment, and continued faith in me, their doctor!
So, I set out to create a company that figured out how to measure what was in the syringe. This was easy to do poorly, but difficult to do well. First, we had to procure and calibrate a separate device that could measure key blood components, then validate those measurements (meaning, we had to decide whether those measurements were both accurate and meaningful).
Next, we built a data capture and analysis platform that could record all of the cellular measurements we were obtaining in our samples and compare them to patient reports of success or failure over time. Finally, given the complexity of the data set, our goal became to develop cutting-edge algorithms to determine what cell types and counts contribute to the most successful treatment possible (we are deep into this part of the equation, and we continue to develop and refine our algorithms).
From day one, I registered the company with the FDA in an effort to be transparent, and I voluntarily subjected the company to periodic audits from the FDA to review what we were doing. In doing so, we gave the FDA the opportunity to offer constructive criticism if they felt the company was doing anything to jeopardize patient safety, or was deviating from federal guidelines.
More than twelve years of work have gone into making an idea on the back of a napkin into a biotech growth company that stands to help advance science and, over time, optimize biologic products that give patients the best chance for a successful outcome. A simple concept, not easy, but one we continue to explore, innovate and test to this day.
Helping Patients Choose Biologics With Confidence
I’ll end with a story. Several years ago, I was meeting with a world-renowned physician and reported thought leader in the orthobiologics space. I presented Greyledge in the hopes of working with him to advance the mission described above. After presenting our work, he responded with the following: “Dave, I think what you are doing is great, but I’m not sure we really know what to measure in these products, so I’m not sure we should measure anything at all…”
I’m rarely speechless, but admittedly it took a few seconds to process. Frankly, I don’t remember my exact response, but the meeting ended shortly after.
What good can happen if we all take this position? Nothing! We would continue to apply a magic soup of cells without a list of ingredients at top dollar. Some patients would get better, others would not, but when queried as to why, most doctors would shrug like my colleague and say we just don’t know what to measure. Without measurement and study, there is no improvement, no progress, and no certainty.
This approach is not sustainable or healthy.
Patients entrust their doctors, and companies who prepare biologic products for them, to know exactly what they promote and deliver. After all, we aren’t playing horseshoes or throwing hand grenades. We are applying cutting-edge, complex biologic therapies with enormous potential to do good. Simply put: “Close is just not good enough.”
Greyledge invites physicians to join us in growing the field of regenerative medicine by creating concrete, trackable data that can be used to make biologic products even more effective for patients. We strive to make utilizing our technology as simple as possible for any provider who is interested. If you’re ready to treat your patients with the most cutting-edge, scientifically-based cell therapy available today, work with a leader in biologics and get started with us, today.