Vadalà Gianluca, Russo Fabrizio, Lavazza Cristiana, Petrucci Giorgia, Ambrosio Luca, Budelli Silvia, Montelatici Elisa, Di Giacomo Giuseppina, Cicione Claudia, Tilotta Veronica, Papalia Giuseppe Francesco, Pileri Matteo, Bruno Amalia, La Rosa Salvatore, Carrino Emilio, Faiella Eliodoro, Carassiti Massimiliano, Lazzari Lorenza, Papalia Rocco, Denaro Vincenzo
Operative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Laboratory for Regenerative Orthopaedics, Research Unit of Orthopaedic and Trauma Surgery Department of Medicine and Surgery, Università Campus Bio-Medico di Roma Rome Italy.
JOR Spine. 2025 Jun 2;8(2):e70086. doi: 10.1002/jsp2.70086. eCollection 2025 Jun.
Low back pain (LBP) is a leading cause of disability worldwide, often associated with intervertebral disc degeneration (IDD). Mesenchymal stromal cells (MSCs) have emerged as a promising regenerative therapy for IDD due to their ability to promote tissue repair. This phase IIB randomized controlled trial aimed to evaluate the safety and efficacy of autologous bone marrow-derived MSC (BM-MSC) intradiscal injections in patients with chronic LBP due to moderate-to-advanced multilevel IDD.
Fifty-two patients with chronic LBP unresponsive to conservative treatments with moderate-to-advanced IDD at up to three lumbar levels were included. Participants were randomized to receive either BM-MSCs or a sham procedure. Clinical outcomes, including pain intensity (VAS), disability (ODI), and quality of life (SF-36), were assessed at baseline, 1-, 3-, and 6-months postinjection. Structural changes were evaluated via MRI using Pfirrmann grading, disc height index (DHI), and T2 mapping at baseline, 3 and 6 months.
Of the 52 enrolled patients, 46 completed the 6-month follow-up (BM-MSC group: = 21; sham group: = 25). BM-MSC injections were well-tolerated, with no major adverse events reported. Structural improvements were observed in the BM-MSC group, including significant increases in DHI and nonsignificant improvements in T2 relaxation times at 3 and 6 months. Modified Pfirrmann grades showed transient improvement at 3 months but returned to baseline at 6 months. Despite these radiological changes, clinical outcomes such as VAS, ODI, and SF-36 scores improved similarly in both groups without significant intergroup differences at any timepoint. The sham group demonstrated slightly greater improvements in disability (ODI) and physical quality-of-life scores (SF-36 PCS).
Autologous BM-MSC intradiscal injection is a safe and promising approach in patients with chronic LBP due to moderate-to-advanced multilevel IDD. However, despite these regenerative effects, no significant clinical advantages over the sham procedure were observed within 6 months of follow-up.
下腰痛（LBP）是全球致残的主要原因，常与椎间盘退变（IDD）相关。间充质基质细胞（MSCs）因其促进组织修复的能力，已成为一种有前景的IDD再生疗法。这项IIB期随机对照试验旨在评估自体骨髓源性MSC（BM-MSC）椎间盘内注射治疗中度至重度多节段IDD所致慢性LBP患者的安全性和有效性。
纳入52例慢性LBP患者，这些患者对保守治疗无效，患有中度至重度IDD，累及最多三个腰椎节段。参与者被随机分为接受BM-MSCs注射或假手术。在基线、注射后1个月、3个月和6个月评估临床结局，包括疼痛强度（VAS）、功能障碍（ODI）和生活质量（SF-36）。在基线、3个月和6个月通过MRI使用Pfirrmann分级、椎间盘高度指数（DHI）和T2映射评估结构变化。
52例入组患者中，46例完成了6个月的随访（BM-MSC组：n = 21；假手术组：n = 25）。BM-MSC注射耐受性良好，未报告重大不良事件。在BM-MSC组观察到结构改善，包括3个月和6个月时DHI显著增加，T2弛豫时间有不显著改善。改良的Pfirrmann分级在3个月时显示短暂改善，但在6个月时恢复到基线。尽管有这些影像学变化，但两组的VAS、ODI和SF-36评分等临床结局在任何时间点均有相似改善，组间无显著差异。假手术组在功能障碍（ODI）和身体生活质量评分（SF-36 PCS）方面的改善略大。
自体BM-MSC椎间盘内注射对于中度至重度多节段IDD所致慢性LBP患者是一种安全且有前景的方法。然而，尽管有这些再生效应，但在随访6个月内未观察到比假手术有显著的临床优势。
