Department of Orthopedics, First Affiliated Hospital of Dalian Medical University, Dalian, Dalian, China.
Department of Orthopedics, First Affiliated Hospital of Dalian Medical University, Dalian, Dalian, China
BMJ Open. 2022 Oct 25;12(10):e063925. doi: 10.1136/bmjopen-2022-063925.
Discogenic low back pain (DLBP) is a common disease, and its occurrence is closely related to intervertebral disc (IVD) degeneration. At present, none of the traditional treatment methods can repair the degenerated IVD. The emergence of stem cell therapy makes it possible to repair and regenerate IVD tissue, among which adipose derived mesenchymal stem cells (ADMSCs) transplantation therapy has become a hot spot of current research. Therefore, this trial aimed to investigate the safety and efficacy of using autologous cultured ADMSCs combined with hyaluronic acid (HA) hydrogel in the treatment of DLBP.
This study is a randomised, dose-escalation, placebo-controlled, double-blind, single-centre, phase II clinical trial to evaluate the efficacy and safety of autologous cultured ADMSCs combined with HA hydrogel in the treatment of patients with DLBP. The 100 eligible patients will be randomly divided into three experimental groups with different doses and one placebo control group in a ratio of 1:1:1:1. All patients will undergo liposuction to obtain ADMSCs, followed by autologous cultured ADMSC mixtures or placebo transplantation after 3 weeks. The patients will be followed up to 24 months after the transplant. The primary end point of this trial is the Visual Analogue Scale. Secondary end points include the Oswestry Disability Index, Japanese Orthopaedic Association Scores, the Mos 36-item short form, the Modic classification, Pfirrmann grade, height and segment range of motion of the IVD, vital signs (temperature, pulse, respiration, blood pressure), blood routine, liver and kidney function, immunological examination, urinalysis and treatment emergent adverse events.
The study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University and registered in the Chinese Clinical Trial Registry. Dissemination of the results will be presented at a conference and in peer-reviewed publications.
ChiCTR2200058291.
椎间盘源性下腰痛（DLBP）是一种常见疾病，其发生与椎间盘（IVD）退变密切相关。目前，传统的治疗方法均不能修复退变的 IVD。干细胞治疗的出现使得修复和再生 IVD 组织成为可能，其中脂肪来源间充质干细胞（ADMSCs）移植治疗已成为当前研究的热点。因此，本试验旨在研究自体培养的 ADMSCs 联合透明质酸（HA）水凝胶治疗 DLBP 的安全性和有效性。
本研究是一项随机、剂量递增、安慰剂对照、双盲、单中心、Ⅱ期临床试验，旨在评估自体培养的 ADMSCs 联合 HA 水凝胶治疗 DLBP 患者的疗效和安全性。100 例合格患者将按照 1:1:1:1 的比例随机分为三组不同剂量实验组和一组安慰剂对照组。所有患者均接受吸脂术获取 ADMSCs，3 周后接受自体培养的 ADMSC 混合物或安慰剂移植。移植后 24 个月进行随访。本试验的主要终点是视觉模拟评分。次要终点包括 Oswestry 功能障碍指数、日本骨科协会评分、MOS 36 项简明健康状况调查问卷、Modic 分类、Pfirrmann 分级、IVD 高度和节段活动度、生命体征（体温、脉搏、呼吸、血压）、血常规、肝肾功能、免疫检查、尿常规和治疗中出现的不良事件。
该研究方案已获得大连医科大学附属第一医院伦理委员会的批准，并在中国临床试验注册中心注册。研究结果将在会议和同行评议的出版物中进行展示。
ChiCTR2200058291。
