Blood is blood. But how it’s processed to make platelet-rich plasma (PRP) for a variety of indications, including aesthetic treatments, might make a difference in PRP treatment outcomes.
As consumer demand for PRP for everything from joint and sexual health to hair restoration and skin rejuvenation increases, the competition for the best PRP preparation system is heating up. But while companies can make claims about what they think is important in PRP processing, strong data to support the claims is lacking.
In a recent non-peer-reviewed white paper, “Platelet-rich Plasma: Be confident in what you’re injecting,” authors suggest Eclipse PRP (Eclipse) outshines other commercial methods for PRP isolation.
The paper is an independent initiative among three collaborators, Drs. Jeffrey Rapaport, Neil Sadick, and Gordon Sasaki, and funded by Eclipse.
The authors write that it’s important for aesthetic physicians and others to be aware that variations in purity, yield and PRP composition resulting from use of different isolation methods will likely affect outcomes from PRP treatment.
They contend there’s plenty of literature supporting PRP’s clinical benefit in the supraphysiologic range and that focusing on the increase in platelet concentration compared to baseline is important, albeit “oversold for marketing purposes.”
“More important than the platelet concentration over baseline may be the total number of platelets injected, what impurities the PRP may contain and notably the ease of use and predictability of the PRP system,” the white paper authors write.
They point to a study published Feb. 2011 in the American Journal of Sports Medicine in which five healthy humans donated 100 mL of blood, which researchers processed with 3 PRP concentration systems to produce PRP. They found no significant differences in average PRP platelet, red blood cell, active transforming growth factor β1, or fibrinogen concentrations among PRP separation systems (which did not include the Eclipse PRP). But the researchers noted a significant difference in platelet capture efficiency. More research is needed to determine if and how these differences are clinically relevant, they conclude.
The white paper authors also cite unpublished data, including five healthy volunteers, which examined three commercial PRP isolation methods: Eclipse PRP, Selphyl (Factor Medical) and Arthrex (Arthrex). While Arthrex processing resulted in the highest increased platelet count, at 6.0 times over baseline, Arthex also produced the highest level of contaminating red blood cells and white blood cells, according to the Eclipse report.
“Eclipse PRP removes the most contaminating cells and resulted in a platelet increase of 3.1x,” according to the paper.
The authors suggest that a supraphysiologic level of platelets of 1.5 to 3 times baseline might be better than levels of 5 times or higher. But more studies are needed to better understand optimal platelet concentration, total platelet numbers and how these are important to clinical outcomes, they write.
Another question about PRP that remains unresolved is the merit of using PRP rich in white blood cells in the clinical setting — especially for aesthetic treatments. Eclipse PRP removes the vast majority of white blood cells, according to the paper.
The authors also point out the importance of using an FDA-cleared product and that the company marketing it uses the proper language for that approval. PRP use in aesthetics is considered off-label, it’s important that clinicians use FDA-cleared systems for PRP preparation and beware that some products are either not listed with the FDA or are cleared only as blood collection tubes and not for PRP preparation and injection at the patient point-of-care, according to the paper. Eclipse PRP is FDA cleared as a Class II Medical Device, according to the Eclipse website. But Eclipse hasn’t always been in compliance with the FDA in its promotional efforts. In a warning letter, the FDA accused Eclipse of providing false or misleading information on its website in 2015 when it promoted Eclipse PRP for cosmetic dermatology and hair loss treatment. Back then, the FDA requested that Eclipse immediately stop promoting Eclipse PRP for unapproved uses.
Eclipse provided funding for the white paper and the authors of the paper include members of the company’s medical and scientific advisory board.