Platelet gel – the Italian way: a call for procedure standardization and quality control

Dear Sir At present, there is growing evidence to prove that treatment with platelet gel accelerates wound healing (Crovetti et al., 2004; Borzini & Mazzucco, 2005a). Moreover, evidence (Marx, 2001) is mounting to show that the crucial factors in the effectiveness of this treatment are the number of platelets used, at least 1 2 10 mL to 2 0 10 mL, in the platelet-enriched plasma (PRP) and the way in which they are processed, as the growth factor content of the gel is highly sensitive to these two variables (Kubota et al., 2004; Borzini & Mazzucco, 2005b). Platelet gel production follows a two-step procedure. First, hyper-concentrated platelets are prepared through platelet sedimentation (differential centrifugation of whole blood) and secondly, the gel is formed by adding fibrinogen-cleaving agents (Ca, thrombin or batroxobin) to PRP, leading to fibrin formation, polymerization, platelet activation and growth factor release. PRP can be prepared either in a blood bank environment, using good laboratory or manufacturing practice or in a clinical point of care, using platelet-sedimentation devices (tubes and centrifuges). Various devices are commercially available to prepare PRP in the clinical point-of-care and the gel should be prepared in proximity to the patient. Devices for PRP gelification are also available in the market. Some devices can perform both phases (platelet sedimentation and PRP gelification). Which kind of PRP should we opt for? The one prepared in a blood bank or the one prepared at the point-of-care? In most western countries, PRP is prepared by using commercial devices at the clinical point-of-care. It is only in Italy that aministerial decree dictates that the production of the PRP can only be carried out in a blood bank, hence only accredited hospital blood transfusion centres are allowed to prepare PRP. Blood transfusion centres are the only facilities, which are deemed able to meet the quality production parameters by the Italian health authorities. Blood bank preparation is able to provide a certificate of analysis of PRP and platelet gel to the patient and the doctor. Table 1 is a hypothetical format of a certificate of analysis. Information from the certificate of analysis should be included on the product s label. If we want platelet gel to be therapeutically effective, then it has to comply with the same standard controls as do the blood components. These standard controls must lead to a formal certificate of analysis. In this way, the clinical value can be better ascertained, as the bias due to the variability of platelet gel preparation is reduced. The crucial parameters to be recorded are the platelet counts for each product and the growth factor content. In fact, the clinical effectiveness of platelet gel is believed to be consistent with the growth factors, which are released in loco (Soffer et al., 2003; Yazawa et al., 2003; Weibrich et al., 2004) In turn, these depend more or less on the platelet concentration. It is necessary to keep a record of these data to evaluate the therapeutic effect of platelet gels through ongoing clinical trials (National Healing Corporation, 2006). In Italy, a consensus conference to establish guidelines for the production of platelet gel is on the agenda of the Istituto Superiore di Sanità, the advisory organ for the Ministry of Health. An open debate needs to be conducted at the European level, so as to bring about a statement of consensus.