Skovrlj Branko, Guzman Javier Z, Al Maaieh Motasem, Cho Samuel K, Iatridis James C, Qureshi Sheeraz A
Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, 1 Gustave L Levy Place, Box 1136, New York, NY 10029, USA.
Department of Orthopaedics, Icahn School of Medicine at Mount Sinai, 5 East 98th St, 9th Floor, Box 1188, New York, NY 10029, USA.
Spine J. 2014 Nov 1;14(11):2763-72. doi: 10.1016/j.spinee.2014.05.024. Epub 2014 Jun 11.
Advances in the field of stem cell technology have stimulated the development and increased use of allogenic bone grafts containing live mesenchymal stem cells (MSCs), also known as cellular bone matrices (CBMs). It is estimated that CBMs comprise greater than 17% of all bone grafts and bone graft substitutes used.
To critically evaluate CBMs, specifically their technical specifications, existing published data supporting their use, US Food and Drug Administration (FDA) regulation, cost, potential pitfalls, and other aspects pertaining to their use.
Areview of literature.
A series of Ovid, Medline, and Pubmed-National Library of Medicine/National Institutes of Health (www.ncbi.nlm.nih.gov) searches were performed. Only articles in English journals or published with English language translations were included. Level of evidence of the selected articles was assessed. Specific technical information on each CBM was obtained by direct communication from the companies marketing the individual products.
Five different CBMs are currently available for use in spinal fusion surgery. There is a wide variation between the products with regard to the average donor age at harvest, total cellular concentration, percentage of MSCs, shelf life, and cell viability after defrosting. Three retrospective studies evaluating CBMs and fusion have shown fusion rates ranging from 90.2% to 92.3%, and multiple industry-sponsored trials are underway. No independent studies evaluating spinal fusion rates with the use of CBMs exist. All the commercially available CBMs claim to meet the FDA criteria under Section 361, 21 CFR Part 1271, and are not undergoing FDA premarket review. The CBMs claim to provide viable MSCs and are offered at a premium cost. Numerous challenges exist in regard to MSCs' survival, function, osteoblastic potential, and cytokine production once implanted into the intended host.
Cellular bone matrices may be a promising bone augmentation technology in spinal fusion surgery. Although CBMs appear to be safe for use as bone graft substitutes, their efficacy in spinal fusion surgery remains highly inconclusive. Large, nonindustry sponsored studies evaluating the efficacy of CBMs are required. Without results from such studies, surgeons must be made aware of the potential pitfalls of CBMs in spinal fusion surgery. With the currently available data, there is insufficient evidence to support the use of CBMs as bone graft substitutes in spinal fusion surgery.
干细胞技术领域的进展推动了含活间充质干细胞（MSCs）的同种异体骨移植（也称为细胞骨基质，CBMs）的发展并增加了其使用。据估计，CBMs占所有使用的骨移植和骨移植替代物的17%以上。
严格评估CBMs，特别是其技术规格、支持其使用的现有已发表数据、美国食品药品监督管理局（FDA）的监管、成本、潜在缺陷以及与使用相关的其他方面。
文献综述。
进行了一系列Ovid、Medline和美国国立医学图书馆/国立卫生研究院的PubMed（www.ncbi.nlm.nih.gov）检索。仅纳入英文期刊上发表的文章或有英文翻译的文章。评估所选文章的证据水平。通过与销售各产品的公司直接沟通，获取每种CBM的具体技术信息。
目前有五种不同的CBM可用于脊柱融合手术。这些产品在收获时的平均供体年龄、总细胞浓度、MSCs百分比、保质期和解冻后的细胞活力方面存在很大差异。三项评估CBMs与融合的回顾性研究显示融合率在90.2%至92.3%之间，多项行业赞助的试验正在进行。不存在评估使用CBMs的脊柱融合率的独立研究。所有市售的CBMs均声称符合FDA第361条、21 CFR Part 1271的标准，且未接受FDA上市前审查。CBMs声称可提供有活力的MSCs，且售价高昂。一旦植入目标宿主，MSCs的存活、功能、成骨潜能和细胞因子产生方面存在诸多挑战。
细胞骨基质在脊柱融合手术中可能是一种有前景的骨增强技术。尽管CBMs作为骨移植替代物使用似乎是安全的，但其在脊柱融合手术中的疗效仍极不确定。需要开展大型的非行业赞助研究来评估CBMs的疗效。在没有此类研究结果的情况下，必须让外科医生了解CBMs在脊柱融合手术中的潜在缺陷。根据目前可得的数据，没有足够的证据支持在脊柱融合手术中使用CBMs作为骨移植替代物。
