Burnouf Thierry, Barro Lassina, Nebie Ouada, Wu Yu-Wen, Goubran Hadi, Knutson Folke, Seghatchian Jerard
Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan; International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan; Research Center of Biomedical Devices, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan; International PhD Program in Cell Therapy and Regeneration Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.
Transfus Apher Sci. 2019 Dec;58(6):102674. doi: 10.1016/j.transci.2019.102674. Epub 2019 Oct 31.
Growth factor-rich pooled human platelet lysate (HPL), made from human platelet concentrates, is one new blood-derived bioproduct that is attracting justified interest as a xeno-free supplement of growth media for human cell propagation for cell therapy. HPL can also find potentially relevant applications in the field of regenerative medicine. Therefore, the therapeutic applications of HPL go far beyond the standard clinical applications of the traditional blood products typically used in patients suffering from life-threatening congenital or acquired deficiencies in cellular components or proteins due to severe genetic diseases or trauma. A wider population of patients, suffering from various pathologies than has traditionally been the case, is thus, now susceptible to receiving a human blood-derived product. These patients would, therefore, be exposed to the possible, but avoidable, side effects of blood products, including transfusion-transmitted infections, most specifically virus transmissions. Unfortunately, not all manufacturers, suppliers, and users of HPL may have a strong background in the blood product industry. As such, they may not be fully aware of the various building blocks that should contribute to the viral safety of HPL as is already the case for any licensed blood products. The purpose of this manuscript is to reemphasize all the measures, including in regulatory aspects, capable of assuring that HPL exhibits a sufficient pathogen safety margin, especially when made from large pools of human platelet concentrates. It is vital to remember the past to avoid that the mistakes, which happened 30 to 40 years ago and led to the contamination of many blood recipients, be repeated due to negligence or ignorance of the facts.
富含生长因子的人血小板浓缩物混合裂解物（HPL）由人血小板浓缩物制成，是一种新的血液衍生生物制品，作为用于细胞治疗的人细胞增殖生长培养基的无动物源补充剂，正吸引着合理的关注。HPL在再生医学领域也可能有相关应用。因此，HPL的治疗应用远远超出了传统血液制品的标准临床应用范围，传统血液制品通常用于因严重遗传疾病或创伤而患有危及生命的先天性或后天性细胞成分或蛋白质缺乏症的患者。因此，现在比以往任何时候都有更多患有各种疾病的患者容易接受人血衍生产品。这些患者因此会接触到血液制品可能但可避免的副作用，包括输血传播感染，最常见的是病毒传播。不幸的是，并非所有HPL的制造商、供应商和使用者都在血液制品行业有深厚背景。因此，他们可能没有充分意识到对HPL病毒安全性有贡献的各种要素，而任何获得许可的血液制品都是如此。本手稿的目的是再次强调所有措施，包括监管方面的措施，以确保HPL具有足够的病原体安全边际，特别是当它由大量人血小板浓缩物制成时。记住过去至关重要，以避免因疏忽或对事实的无知而重蹈30至40年前发生的错误覆辙，当时这些错误导致许多输血接受者受到污染。
