Cellular bone matrices: viable stem cell-containing bone graft substitutes.
Cellular bone matrices: viable stem cell-containing bone graft substitutes.
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DOI：
10.1016/j.spinee.2014.05.024
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发表时间：
2014-11-01
期刊：
影响因子：
--
通讯作者：
Qureshi SA
中科院分区：
文献类型：
--
作者：
Skovrlj B;Guzman JZ;Al Maaieh M;Cho SK;Iatridis JC;Qureshi SA
干细胞技术领域的进步刺激了含有活间充质干细胞（MSC）（也称为细胞骨基质（CBM））的同种异体骨移植物的开发和增加使用。据估计，CBM 占所有使用的骨移植物和骨移植替代物的 17% 以上。严格评估 CBM，特别是其技术规格、支持其使用的现有已发布数据、美国食品和药物管理局 (FDA) 法规、成本、潜在陷阱以及与其使用相关的其他方面。文学评论。进行了一系列 Ovid、Medline 和 Pubmed-国家医学图书馆/国立卫生研究院 (www.ncbi.nlm.nih.gov) 检索。仅包含英文期刊上的文章或以英文翻译发表的文章。对所选文章的证据水平进行了评估。每个 CBM 的具体技术信息是通过与销售各个产品的公司直接沟通获得的。目前有五种不同的 CBM 可用于脊柱融合手术。产品之间在收获时供体的平均年龄、总细胞浓度、MSC 百分比、保质期和解冻后细胞活力方面存在很大差异。三项评估 CBM 和融合的回顾性研究显示融合率在 90.2% 到 92.3% 之间，多项行业赞助的试验正在进行中。目前尚无评估使用 CBM 的脊柱融合率的独立研究。所有市售 CBM 均声称符合 FDA 第 361 条、21 CFR 第 1271 部分规定的标准，并且未接受 FDA 上市前审查。 CBM 声称提供可行的 MSC，并且价格较高。一旦植入预期宿主，间充质干细胞的存活、功能、成骨细胞潜力和细胞因子的产生存在许多挑战。细胞骨基质可能是脊柱融合手术中一种有前途的骨增强技术。尽管 CBM 用作骨移植替代品似乎是安全的，但它们在脊柱融合手术中的功效仍然非常不确定。需要进行大型、非行业资助的研究来评估 CBM 的功效。如果没有此类研究的结果，外科医生必须意识到 CBM 在脊柱融合手术中的潜在缺陷。根据目前可用的数据，没有足够的证据支持在脊柱融合手术中使用 CBM 作为骨移植替代品。
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.
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DOI：
10.1097/00005373-200202000-00020
发表时间：
2002-02-01
影响因子：
--
作者：
Chen, WJ;Lai, PL;Tai, CL
通讯作者：
Tai, CL
影响因子：
3
作者：
Cui, QJ;Xiao, ZM;Wang, GJ
通讯作者：
Wang, GJ
影响因子：
4.5
作者：
Fariha, Mohd-Manzor Nur;Chua, Kien-Hui;Hayati, Abdul-Rahman
通讯作者：
Hayati, Abdul-Rahman
影响因子：
5.3
作者：
Cuomo, Anna V.;Virk, Mandeep;Lieberman, Jay R.
通讯作者：
Lieberman, Jay R.
DOI：
10.1111/j.1365-2184.1970.tb00347.x
发表时间：
1970-01-01
期刊：
CELL AND TISSUE KINETICS
影响因子：
--
作者：
FRIEDENSTEIN, AJ;CHAILAKHJAN, RK;LALYKINA, KS
通讯作者：
LALYKINA, KS