Romagna Transplant Network, Hematology Unit, Ravenna, Via Randi 5, Ravenna, Italy.
International Consultancy in Strategic Safety/Quality Innovations of Blood- Derived Bioproducts and Quality Audit/Inspection, London, England, UK.
Transfus Apher Sci. 2020 Oct;59(5):102940. doi: 10.1016/j.transci.2020.102940. Epub 2020 Sep 4.
Stem cell therapy is a relatively novel field of investigation, in which either differentiated cells or stem cells capable of differentiation are transplanted into an individual with the objective of yielding specific cell types in the damaged tissue and consequently restoring its function. The most successful example of cell therapy is hematopoietic stem cell transplantation, leading to regeneration of a patient's blood cells, now a widely established procedure for many oncologic and non-oncologic diseases. Innovative cell-based therapies are being developed to replace, regenerate or repair injured, absent, or diseased tissues and organs. However, cell therapy bioproducts are based on their inherent biological features such as proliferation, migratory, capability, plasticity, and capacity of self-renewal, posing serious challenges during such bioproduct development. The extraordinary promise of stem cells for future treatments of otherwise intractable diseases has raised great hope and expectations in patients, advocates, physicians, and researchers alike. However, despite thousands of scientific publications and research programs, increased efforts need to be put into the identification of the factors involved, biological mechanisms and materials that affect safety/ efficacy, and into the design of cost-effective methods for the harvesting, expansion, manipulation and purification of the cells.
干细胞疗法是一个相对较新的研究领域,通过将分化细胞或具有分化能力的干细胞移植到个体中,以产生损伤组织中的特定细胞类型,并由此恢复其功能。细胞疗法最成功的例子是造血干细胞移植,导致患者血细胞的再生,现在已成为许多肿瘤和非肿瘤疾病广泛应用的一种程序。创新性的基于细胞的疗法正在被开发,以替代、再生或修复受损、缺失或患病的组织和器官。然而,细胞治疗生物制品基于其内在的生物学特性,如增殖、迁移、能力、可塑性和自我更新能力,在生物制品开发过程中带来了严峻的挑战。干细胞在未来治疗其他难以治疗的疾病方面的巨大潜力,给患者、倡导者、医生和研究人员带来了巨大的希望和期望。然而,尽管有数千篇科学出版物和研究计划,仍需要投入更多的努力来确定涉及的因素、影响安全性/疗效的生物学机制和材料,并设计出具有成本效益的方法来收获、扩增、操作和纯化细胞。