Spinal fusion surgery is increasingly common; however, pseudarthrosis remains a common complication affecting as much as 15% of some patient populations. Currently, no clear consensus on the best bone graft materials to use exists. Recent advances have led to the development of cell-infused cellular bone matrices (CBMs), which contain living components such as mesenchymal stem cells (MSCs). Relatively few clinical outcome studies on the use of these grafts exist, although the number of such studies has increased in the last 5 years. In this study, the authors aimed to summarize and critically evaluate the existing clinical evidence on commercially available CBMs in spinal fusion and reported clinical outcomes.

The authors performed a systematic search of the MEDLINE and PubMed electronic databases for peer-reviewed, English-language original articles (1970–2020) in which the articles’ authors studied the clinical outcomes of CBMs in spinal fusion. The US National Library of Medicine electronic clinical trials database (www.ClinicalTrials.gov) was also searched for relevant ongoing clinical trials.

Twelve published studies of 6 different CBM products met inclusion criteria: 5 studies of Osteocel Plus/Osteocel (n = 354 unique patients), 3 of Trinity Evolution (n = 114), 2 of ViviGen (n = 171), 1 of map3 (n = 41), and 1 of VIA Graft (n = 75). All studies reported high radiographic fusion success rates (range 87%–100%) using these CBMs. However, this literature was overwhelmingly limited to single-center, noncomparative studies. Seven studies disclosed industry funding or conflicts of interest (COIs). There are 4 known trials of ViviGen (3 trials) and Bio4 (1 trial) that are ongoing.

CBMs are a promising technology with the potential of improving outcome after spinal fusion. However, while the number of studies conducted in humans has tripled since 2014, there is still insufficient evidence in the literature to recommend for or against CBMs relative to cheaper alternative materials. Comparative, multicenter trials and outcome registries free from industry COIs are indicated.

脊柱融合手术越来越普遍；然而，假关节病仍然是一种常见的并发症，影响多达 15% 的一些患者群体。目前，尚无关于最佳骨移植材料的明确共识。最近的进展导致了细胞注入细胞骨基质 (CBM) 的发展，其中包含间充质干细胞 (MSC) 等活体成分。尽管此类研究的数量在过去 5 年中有所增加，但关于使用这些移植物的临床结果研究相对较少。在这项研究中，作者旨在总结和批判性地评估现有的关于脊柱融合中市售 CBM 的临床证据和报告的临床结果。

作者对 MEDLINE 和 PubMed 电子数据库进行了系统搜索，以寻找经过同行评审的英文原创文章（1970-2020 年），其中文章的作者研究了 CBM 在脊柱融合术中的临床结果。还搜索了美国国家医学图书馆电子临床试验数据库 (www.ClinicalTrials.gov) 以查找相关正在进行的临床试验。

12 项关于 6 种不同 CBM 产品的已发表研究符合纳入标准：5 项 Osteocel Plus/Osteocel 研究（n = 354 名独特的患者）、3 项 Trinity Evolution（n = 114）、2 项 ViviGen（n = 171）、1 项 map3（ n = 41) 和 VIA Graft 的 1 (n = 75)。所有研究都报告了使用这些 CBM 的高影像融合成功率（范围 87%–100%）。然而，这些文献绝大多数限于单中心、非比较研究。七项研究披露了行业资金或利益冲突 (COI)。ViviGen（3 项试验）和 Bio4（1 项试验）的 4 项已知试验正在进行中。

CBM 是一种很有前途的技术，具有改善脊柱融合术后结果的潜力。然而，虽然自 2014 年以来在人体中进行的研究数量增加了两倍，但相对于更便宜的替代材料，文献中仍然没有足够的证据来推荐或反对 CBM。指出了没有行业 COI 的比较性、多中心试验和结果登记。