Department of Biomedical Engineering, Johns Hopkins University, Baltimore, Maryland, USA.
Tissue Eng Part B Rev. 2012 Feb;18(1):62-75. doi: 10.1089/ten.TEB.2011.0209. Epub 2012 Jan 4.
Tissue engineered bone grafts have the potential to be used to treat large bone defects due to congenital abnormalities, cancer resections, or traumatic incidents. Recent studies have shown that perfusion bioreactors can be used to generate grafts of clinically relevant sizes and shapes. Despite these scientific and technological successes, there is uncertainty regarding the translational utility of bioreactor-based approaches due to the perceived high costs associated with these procedures. In fact, experiences over the past two decades have demonstrated that the widespread application of cell-based therapies is heavily dependent on the commercial viability. In this article, we directly address the question of whether bioreactors used to create bone grafts have the potential to be implemented in clinical approaches to bone repair and regeneration. We provide a brief review of tissue engineering approaches to bone repair, clinical trials that have employed cell-based methods, and advances in bioreactor technologies over the past two decades. These analyses are combined to provide a perspective on what is missing from the scientific literature that would enable an objective baseline for weighing the benefit of extended in vitro cultivation of cells into functional bone grafts against the cost of additional cultivation. In our estimation, the cost of bioreactor-based bone grafts may range from $10,000 to $15,000, placing it within the range of other widely used cell-based therapies. Therefore, in situations where a clear advantage can be established for engineered grafts comprising patient-specific, autologous cells, engineered bone grafts may be a clinically feasible option.
组织工程骨移植物有可能用于治疗由于先天异常、癌症切除或创伤事件引起的大骨缺损。最近的研究表明,灌注式生物反应器可用于生成具有临床相关尺寸和形状的移植物。尽管在科学和技术上取得了这些成功,但由于与这些程序相关的高成本,人们对基于生物反应器的方法的转化实用性存在不确定性。事实上,过去二十年的经验表明,细胞疗法的广泛应用严重依赖于商业可行性。在本文中,我们直接探讨了用于创建骨移植物的生物反应器是否有可能应用于骨修复和再生的临床方法。我们简要回顾了骨修复的组织工程方法、已采用细胞方法的临床试验以及过去二十年中生物反应器技术的进展。这些分析结合起来,提供了对科学文献中缺失的内容的看法,这些内容将使我们能够客观地衡量将细胞体外培养延长以形成功能性骨移植物的益处与额外培养成本之间的平衡。根据我们的估计,基于生物反应器的骨移植物的成本可能在 10000 美元至 15000 美元之间,处于其他广泛使用的细胞疗法的范围内。因此,在可以为包含患者特异性、自体细胞的工程化移植物确立明显优势的情况下,工程化骨移植物可能是一种临床可行的选择。