Ambrosio Luca, Petrucci Giorgia, Russo Fabrizio, Cicione Claudia, Papalia Rocco, Vadalà Gianluca, 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. 2024 May 24;7(2):e1329. doi: 10.1002/jsp2.1329. eCollection 2024 Jun.
Chronic discogenic low back pain (LBP) poses a significant global burden, yet effective therapeutic interventions directly targeting the underlying degenerative process remain elusive. After demonstrating promising results in preclinical studies, intradiscal injection of cell-based treatments has been increasingly investigated in the clinical setting. However, most clinical trials failed to reach publication, with the few available reports showing only minor improvements. The aim of this study was to analyze the prospective clinical trials registered on ClinicalTrials.gov investigating cell therapies for LBP, with a specific emphasis on identifying critical obstacles hindering study completion, including trial design and funding sources.
A systematic search of prospective clinical trials investigating cell-based treatments for chronic LBP due to intervertebral disc degeneration was performed on ClinicalTrials.gov. Extracted data encompassed study design, recruitment, experimental treatment modalities, investigated outcomes, current status, completion date, publication status, and funding sources. Fisher's exact test assessed associations between categorical variables, while a multiple logistic regression model aimed to identify factors potentially linked to the publication status of the studies.
Our search identified 26 clinical trials. Among these, only 7 (26.9%) were published, and none of the other studies marked as completed reported any results on ClinicalTrials.gov. Fifty percent of included trials were funded by universities, whereas the rest was sponsored by industry (38.5%) or private institutions (11.5%). Experimental treatments primarily involved cell-based or cell-derived products of varying sources and concentrations. Products containing carriers, such as hyaluronic acid or fibrin, were more frequently funded by industry and private organizations ( = 0.0112). No significant differences emerged when comparing published and nonpublished studies based on funding, as well as between publication status and other variables.
Most clinical trials exploring cell-based disc regenerative therapies for chronic LBP have never reached completion, with only a small fraction reporting preliminary data in publications.
慢性椎间盘源性下腰痛（LBP）给全球带来了沉重负担，但直接针对潜在退变过程的有效治疗干预措施仍难以捉摸。在临床前研究中取得有前景的结果后，椎间盘内注射基于细胞的治疗方法在临床环境中得到了越来越多的研究。然而，大多数临床试验未能发表，少数可用报告仅显示有轻微改善。本研究的目的是分析在ClinicalTrials.gov上注册的针对LBP的细胞疗法的前瞻性临床试验，特别强调识别阻碍研究完成的关键障碍，包括试验设计和资金来源。
在ClinicalTrials.gov上对研究基于细胞的治疗方法用于因椎间盘退变引起的慢性LBP的前瞻性临床试验进行系统检索。提取的数据包括研究设计、招募、实验治疗方式、研究结果、当前状态、完成日期、发表状态和资金来源。Fisher精确检验评估分类变量之间的关联，而多元逻辑回归模型旨在识别可能与研究发表状态相关的因素。
我们的检索识别出26项临床试验。其中，仅7项（26.9%）发表，其他标记为已完成的研究在ClinicalTrials.gov上均未报告任何结果。纳入试验的50%由大学资助，其余由行业（38.5%）或私人机构（11.5%）赞助。实验治疗主要涉及不同来源和浓度的基于细胞或细胞衍生的产品。含有载体（如透明质酸或纤维蛋白）的产品更常由行业和私人组织资助（P = 0.0112）。基于资金比较已发表和未发表的研究，以及发表状态与其他变量之间，均未发现显著差异。
大多数探索基于细胞的椎间盘再生疗法治疗慢性LBP的临床试验从未完成，只有一小部分在出版物中报告了初步数据。
