What Is Supershot PRP?
Can you isolate exosomes from blood and then enhance the PRP made from that same blood to make it better? This is the intriguing question behind a product calling itself Supershot PRP. Let’s dig in.
What Is an Exosome?
Before we get into understanding Supershot PRP, we need to review some basics. An exosome is a little vesicle given off by a cell as a form of communication or for controlling other cells. Think of an exosome like an envelope in which a message is placed. Every cell in your body gives off exosomes. Hence, exosomes aren’t such a big deal unless you know what the message is and how that can help cells. Meaning the message could be anything from “make a cancer cell” to “repair cartilage”. At this point, we’re still figuring out which message is which. Hence, we do not yet have the knowledge to make an exosome product that we know will benefit somebody. To learn more see my video below:
Exosome Hype
For gullible health care providers, exosomes have been all the rage. Why the hype? On the good side, one day, when we figure out how to produce exosome products with the right messages inside the envelopes, this should be an exciting field. However, most physicians and patients haven’t done their homework to know that just demonstrating that some product has exosomes is meaningless. Why? It’s like paying a bunch of money for “envelopes” without knowing what’s in the envelopes. It’s basically just a marketing strategy at this point.
Where does Supershot PRP fit in? A great idea, or more hype? Read on.
Exosomes and PRP
As I have previously blogged, your PRP contains and your individual platelets secrete loads of exosomes (1-16) Hence, in many ways, platelet-rich plasma, which is concentrating your blood platelets and re-injecting them into a damaged area is already an exosome treatment.
What’s the difference between a stem cell or platelet-rich plasma procedure and just injecting exosomes without cells? Both stem cells and platelets detect what’s in the microenvironment and then excrete the exosomes (messages) that make sense to complete the repair job. Remember that exosomes are just the envelopes for the messages. So without the intelligence of the cells knowing which messages to insert in the envelope, just concentrating and injecting envelopes with random messages is not helpful. As you’ll see below, Supershot PRP is more like an expensive envelope product.
Exosome Products?
It doesn’t take a rocket scientist to see that FDA will likely go hard after a number of companies who advertise exosome products derived from amniotic fluid and/or growing stem cells in culture come the end of their discretionary period in May:
How About Supercharging PRP with Exosomes?
What if you could draw blood, make PRP, and then take exosomes out of the PPP and use them to enhance the PRP? Remember, PPP is platelet-poor plasma or the stuff you’re leftover once you make PRP (platelet-rich plasma). Sounds interesting, right? That’s the basic idea behind Supershot PRP.
However, there are a couple of easy to see problems here:
- How would you isolate the exosomes? This normally takes an expensive ultracentrifuge.
- Once you had your exosomes, you have no way of telling if they’re a net positive or a net negative to the patient. Meaning, adding PPP exosomes may well make your PRP less effective rather than more. We just don’t know yet.
Supershot PRP
A company with a product it calls Supershot PRP has entered the space of trying to supercharge PRP with the exosomes from PPP. This company sells a bottle filled with polyethylene glycol and high-weight dextran. These are both commonly used cell isolation liquids that trap cells from blood or bone marrow during centrifugation.
How does the Supershot PRP kit work? You add this stuff to your PPP and then recentrifuge and the exosomes are supposed to be left in the bottom of the tube. Hence, you remove the cloudy stuff at the bottom and add it to your PRP.
There is some basic science that supports the idea that using PEG and/or Dextran or a mix without fancy lab equipment like an ultracentrifuge can concentrate exosomes (17, 18). In fact, one of the papers I referenced even gives you the right mix that they found worked best after several experiments:
While this likely looks literally like Greek, “System C” performed the best to isolate exosomes at 3.5% PEG and 1.5% Dextran by weight.
How does this work at the usual centrifuge speeds? The mixture traps about 70% of the exosomes and makes them heavier so that they end up in the bottom of the tube by using an inexpensive centrifuge.
$450 for PEG/Dextran?
Supershot PRP costs about $450. So while we have no idea whether this technique gets you anything that will really supercharge or hurt your PRP, we do know that these chemicals are dirt cheap. My best guess as of this writing and after performing some online research is that a compounding pharmacy could mix this up, with sterility testing, for $10-40 a bottle on the high end. That includes sterility testing.
Regulatory Issues
As discussed above, we know that FDA has a real problem with people who are claiming to sell exosomes. So what’s on the Supershot PRP website?
There’s only one number I need to see and that’s “20”. That’s the number of times the term “exosomes” appears on this page. IMHO, that’s a huge regulatory red flag.
In addition, Supershot PRP takes two existing FDA-approved products (PEG and Dextran) and places them in a specific ratio and concentration, and then sells that new bottle as something else called “Superhot”. IMHO that’s a new combination product that requires a separate drug approval no different than adding an already approved cholesterol drug to an already approved blood pressure medication and selling the combo pill as a new drug. So while a physician could have these compounded for a specific patient, once a company puts a new label on this as a brand name product and sells it to distributors who then sell it to physicians, that’s a new drug requiring clinical trials.
Lab Data
Finally, the company includes this graph on the Supershot PRP website:
The idea here is that Supershot PRP helped stem cells grow in culture, which is called a biologic assay. The problem? Just regular old PPP when added to a stem cell culture will stimulate some growth. What would be interesting here would be adding the Supershot isolate to PRP and then comparing the stem cell stimulation of that mixture to PRP without Supershot. You could also do the same with PPP. We may do that study in our advanced lab.
The upshot? IMHO Supershot PRP is not ready for prime time based on the data presented. There is a real question as to whether isolating exosomes from PPP and adding that to PRP will help the patient more than just plain old PRP. IMHO, there’s also a real regulatory question here. First, exosomes are one area where the FDA is on the warpath right now. Second, putting two existing products into a new vial and slapping a new name on it creates a new and unapproved combination drug product.
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References:
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