Novel therapeutic concepts based on autologous blood components - exemplified by autologous platelet gel (APG)

Autologous platelet gel (APG) was developed in the early 1970's as a by-product of the multi-component apheresis, so-called. APG is a matrix composed of fibrin and platelets, and was initially used as a wound sealant. Thrombin and calcium cause platelet aggregation, with the releases of growth factors in the gel. There is clinical evidence for assuming that the growth factors enhance wound healing by stimulating tissue vascularity by increasing the rate of angiogenesis. In addition, APG has a haemostatic effect and causes lymphatic sealing. This leads to reduced seroma formation, and thus to less postoperative pain. The intra-operative production of APG for local application and as a source of growth factors that promote wound healing, forms part of the perioperative autologous haemotherapy, and is subject to the legal regulations applicable in Germany. The 1211 amendment of the German drug law and the latest revision of the German transfusion act have tightened the legal requirements for the production and application of autologous blood products. An important legal question is whether such procedures must be considered drug production as defined by the German drug law, or not. If yes, it is obvious, that most German hospitals cannot comply with the legal stipulations for intra-operative drug production. Because German legislators have so far not come up with a clear legal definition of the status of novel perioperative autologous blood products, this could result in the end of the use of such techniques in our clinical routine, and a situation in which no "evidence class one study" can be conducted to investigate the safety and efficacy of these novel procedures. The concept of the "near patient unit" is new, and therefore not yet established clinically. For perioperative autologous haemotherapy this concept defines the minimum legal requirements for the safe production and application of autologous blood products outside the scope of both the German drug law and the German transfusion act, but still in conformity with the most recent guidelines on haemotherapy, as published by the German Medical Council. The legal end points are: No distribution to a third party, unambiguous personal identity for the production and application, conducted exclusively by qualified medical staff, and an immediate relationship to the planned operation as an integral part of the method. The German legislator needs to modify both the German drug law and the German transfusion act in such a way as to provide legal certainty for the user of perioperative haemotherapy.