PRP application in clinical research approved by FDA with an emphasis on wound healing

Platelet-rich plasma (PRP) is a concentration of human platelet in a small volume of plasma. PRP has seen increased interest and utilization over the past decade, in various medical fields particularly in orthopedics and wound healing.While PRP is not ‘FDA-approved’, it can legally propone in the clinic ‘off-label’ in the USA for a myriad of musculoskeletal indications.Regulatory bodies including the US Food and Drug Administration (FDA) have established more precise definitions, which requires that the blood be collected by a single, uninterrupted venipuncture, centrifuged, and contain at least 250,000 platelets per microliter. The beneficial biological effects of PRP are most commonly associated with the high concentration of growth factors it contains. One of the few aspects of PRP that is reasonably well understood is its safety profile. Recent meta-analyses have shown that severe adverse events attributable to the treatment are almost never reported, in some cases, suggest that PRP may have clinically significant effects. The use of platelet-rich plasma is a promising approach in modern medicine.Three key factors are often related with the high demand for PRP and similar blood derived products: 1- its scientific underpinnings, 2- the ease and relative non-invasive nature in which it can be obtained, and 3- its well-established safety record.PRP is a biologic drug, PRP is not considered a HCT/P. In the case of PRP, the original predicate device is a platelet and plasma separator that produces PRP that is intended to be mixed with bone graft materials to enhance handling properties or in the case of PRP gel, to maintain moisture in a wound. FDA clearance allows PRP to be used for a wide range of different orthopedic indications. In 2010, PRP was given the category III CPT code, ‘0232T’a temporary code used for emerging technologies, services, and operation.