Lorio Morgan P, Tate Jordan Lee, Myers Thomas J, Block Jon E, Beall Douglas P
Advanced Orthopedics, Altamonte Springs, FL, USA.
Southern Pain and Spine Associates, Jasper, GA, USA.
J Pain Res. 2024 Mar 18;17:1171-1182. doi: 10.2147/JPR.S441180. eCollection 2024.
Specific clinical diagnostic criteria have established a consensus for defining patients with lumbar discogenic pain. However, if conservative medical management fails, these patients have few treatment options short of surgery involving discectomy often coupled with fusion or arthroplasty. There is a rapidly-emerging research effort to fill this treatment gap with intradiscal therapies that can be delivered minimally-invasively via fluoroscopically guided injection without altering the normal anatomy of the affected vertebral motion segment. Viable candidate products to date have included mesenchymal stromal cells, platelet-rich plasma, nucleus pulposus structural allograft, and other cell-based compositions. The objective of these products is to repair, supplement, and restore the damaged intervertebral disc as well as retard further degeneration. In doing so, the intervention is meant to eliminate the source of discogenic pain and avoid surgery. Methodologically rigorous studies are rare, however, and based on the best clinical evidence, the safety as well as the magnitude and duration of clinical efficacy remain difficult to estimate. Further, we summarize the US Food and Drug Administration's (FDA) guidance regarding the interpretation of the minimal manipulation and homologous use criteria, which is central to designating these products as a tissue or as a drug/device/biologic. We also provide perspectives on the core evidence and knowledge gaps associated with intradiscal therapies, propose imperatives for evaluating effectiveness of these treatments and highlight several new technologies on the horizon.
特定的临床诊断标准已就腰椎间盘源性疼痛患者的定义达成了共识。然而，如果保守治疗失败，这些患者除了进行通常伴有融合或关节成形术的椎间盘切除术外，几乎没有其他治疗选择。目前正在迅速开展研究工作，以通过椎间盘内治疗来填补这一治疗空白，这种治疗可通过透视引导下的注射以微创方式进行，而不会改变受影响椎体运动节段的正常解剖结构。迄今为止，可行的候选产品包括间充质基质细胞、富血小板血浆、髓核结构同种异体移植物以及其他基于细胞的组合物。这些产品的目标是修复、补充和恢复受损的椎间盘，并延缓其进一步退变。这样做的目的是消除椎间盘源性疼痛的根源并避免手术。然而，方法严谨的研究很少，并且基于最佳临床证据，其安全性以及临床疗效的程度和持续时间仍然难以估计。此外，我们总结了美国食品药品监督管理局（FDA）关于最低限度操作和同种使用标准解释的指南，这对于将这些产品指定为组织或药物/器械/生物制品至关重要。我们还提供了与椎间盘内治疗相关的核心证据和知识空白的观点，提出了评估这些治疗效果的必要性，并强调了一些即将出现的新技术。
