'Reasonable compromise' to define the quality standards of platelet concentrate for non-transfusion use (CPunT)

摘要

Platelets concentrate for non-transfusion use (CPunT) is a blood component specific for regenerative medicine. This blood component has found regenerative applications in many clinical fields (orthopedic, plastic surgery, maxillofacial surgery) since platelets contain growth factors, cytokines and bioactive molecules. Plasticity and ease of preparation of this blood component has often led the user to prepare it without using standardized procedures and references to quality product standards, but to evaluate the effectiveness of treatments and to standardize clinical protocols, is essential. The complexity of establish functional and non-functional parameters to define CPunT properties is linked to three fundamental steps: variability and bioavailability of biomolecules content in platelets, variability in product preparation. Then it is very difficult to understand which are the real parameters to evaluate, but it seems a "reasonable compromise" to establish content of platelets×ml (1×109ml) as reference realistic parameter for CPunT qualification.