Novel Therapeutic Options due to Autologous Blood Components – Exemplified by Autologous Platelet Gel

Abstract

Autologous platelet gel (APG) was developed in the early 1970s as a byproduct of the so-called multi-component apheresis. APG is a matrix composed of fibrin and platelets, and was initially used as a wound sealing. Due to the effects of both thrombin and calcium, the platelets aggregates, resulting in a release of several growth factors. There is clinical evidence that the growth factors released enhance wound healing by stimulating tissue vascularity due to an increased rate of angiogenesis. Apart from that, APG acts hemostatic and causes a lymphatic sealing. This effect leads to less seroma and thus to less pain postoperatively. The intraoperative production of APG for local application and as source of growth factors which serves as promoters of wound healing is part of the perioperative autologous hemotherapy and has to meet the legal regulations in Germany. The 12th amendment of the German Drug Law and the latest revision of the German Transfusion Act have aggravated the legal requirements for the production and application of autologous blood products. It is predominant regarding the legal question whether or not one has to account those procedures as drug production in accordance to the German Drug Law. If one has to account, it is quite obvious that most of the German hospitals cannot meet the legal requirements of an intraoperative drug production. Because the German legislator has so far not defined a clear legal frame for novel perioperative autologous blood products, this could lead to the end of use of those techniques in our clinical routine. Thus, leading to the situation that no ‘evidence class 1 study’ will be conducted in order to investigate safety and efficacy of these novel procedures. The concept of the ‘near patient unit’ is new and therefore clinically not yet established. For perioperative autologous hemotherapy this concept defines the minimum legal requirements for a safe production and application of autologous blood products, outside of the scope of both, the German Drug Law and the German Transfusion Act, but still in accordance with the most recent guidelines on hemotherapy, as published by the Federal Medical Association (Bundesärztekammer). The legal end points are: no distribution to a third party, a strict personal identity for the production and application, exertion only by qualified persons, and an immediate connection to the planned operation as part of the method. The German legislator should modify both, the German Drug Law and German Transfusion Act in a way, to provide a legal certainty for the use of the perioperative hemotherapy.