Fibroblast growth factors (FGFs) and their receptors (FGFRs) regulate several functions of somatic cells. In a previous work, we reported FGFR expression in human spermatozoa and their involvement in motility. This study aimed to evaluate the presence and localization of fibroblast growth factor 2 (FGF2) in human spermatozoa, to determine the relationship of FGF2 levels with conventional semen parameters and to assess the effect of recombinant FGF2 (rFGF2) on sperm recovery in a selection procedure. Western immunoblotting analysis using an antibody against FGF2 revealed an 18-kDa band in sperm protein extracts. The protein was immunolocalized in the sperm flagellum and acrosomal region, as well as in all germ cells. Sperm FGF2 levels, assessed by flow cytometry, showed a positive (p < 0.05) correlation with sperm concentration, motility, total sperm number and total motile cells per ejaculate. Moreover, samples with abnormal motility depicted diminished (p < 0.01) FGF2 levels compared to those with normal motility. Spermatozoa exposed to rFGF2 bound the protein, exhibited higher (p < 0.05) total and motile sperm recoveries, and increased (p < 0.01) kinematic parameters after the swim-up. Findings herein presented lead to consider sperm FGF2 level as a potential marker of sperm quality, and rFGF2 as a supplement for improving sperm recovery in selection techniques.

These data support the feasibility of a routine 6-month program of evaluating mothers and babies giving cord blood at a cord blood bank. Such programs may increase the quality of components stored for transplantation.

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Quality management systems (QMS) are central to FACT-JACIE accreditation standards for haematopoietic cell therapy (HCT) programmes. The quality management plan (QMP) defines the acceptable level of quality of the activities performed or of the products released by the HCT programme and describes how this level of quality in its deliverables and work processes will be ensured. An integrated HCT programme may have a single or several QMPs that addresses all aspects of the clinical, collection, and processing facilities, whilst separate organizations providing the components of an HCT programme may have distinct QMPs joined via service-level agreements (SLAs) and other arrangements. The QMP or QMPs must detail all key elements that affect the quality of recipient and donor care and cellular therapy products. The specific SOPs to be followed for each of these elements should be referenced within QMPs, and linked to the appropriate document where the details are described. The thoroughness in preparation of a QMP and its implementation reflect how quality is perceived within the HCT programme and by external inspectors in the accreditation process.

Cell therapies are required to meet with compulsory regulations that co-exist with other optional standards and guidelines that together compose a complex quality management system. Indeed, reliable insights on the mechanisms of action and safety of novel cell-based therapies require adherence to solid quality management structures in all steps of the value chain, from early research and tissue procurement to clinical trials and biovigilance, thus guaranteeing reproducibility and solid foundations for better science and improved clinical practice. Herein we present the concept of the quality ecosystem as a tool to understand and assist all stakeholders involved in developing and structuring the integration of standards as novel developments are taking place. We conclude that the various quality management initiatives can all be thought about under the umbrella of an ecosystem.