Hedman Thomas, Yu James, Singh Harwant, Deer Timothy
F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USA.
Sydney Spine and Pain, Waratah Private Hospital, Hurstville, New South Wales, Australia.
J Pain Res. 2023 Aug 10;16:2777-2789. doi: 10.2147/JPR.S413104. eCollection 2023.
Genipin is a polymer-forming collagen bonding substance that can be dissolved in a buffered carrier and injected into disc annulus tissues. Therapeutic benefit is derived from the mechanical support provided by a large number of genipin polymers attached to collagen fibers in a degraded disc.
STUDY DESIGN/SETTING: IRB-approved prospective, multi-site, single-arm, 12-month feasibility studies were undertaken in two countries to evaluate the safety and efficacy of the genipin-based implant for treating discogenic chronic low back pain (CLBP).
Twenty CLBP patients with symptomatic discs at one or two levels were enrolled in the study.
The primary safety endpoint was serious adverse events at 1 month, and the primary efficacy endpoint was reduction of pain and disability at 3 months. Secondary efficacy endpoints included reduction of pain and disability at 2 weeks, 1 month, 6 months, and 12 months; reduction of flexion-extension instability; increase in segmental lordosis and rotation; and patient satisfaction.
Fluoroscopic image-guidance was used to deliver two posterolateral injections of buffered genipin to each symptomatic disc. Flexion-extension radiographs were used to quantify joint kinematics at three time-points.
Clinically meaningful improvements in pain and disability scores were reported in 80% or more of patients from 2 weeks to 1 year post-treatment. For the more severely unstable joints, treatment significantly reduced the instability score from a pre-treatment level of 2.4 standard deviations above the mean for an asymptomatic population to the asymptomatic mean at the 3-month follow-up.
These initial clinical data demonstrate the safety and efficacy of a genipin-based collagen tethering device capable of improving spinal joint stability while successfully addressing CLBP. This work merits additional randomized clinical studies.
京尼平是一种可形成聚合物的胶原蛋白结合物质，可溶解于缓冲载体中并注入椎间盘组织。治疗益处源于附着在退变椎间盘中胶原纤维上的大量京尼平聚合物提供的机械支撑。
研究设计/地点：在两个国家开展了经机构审查委员会批准的前瞻性、多中心、单臂、为期12个月的可行性研究，以评估基于京尼平的植入物治疗椎间盘源性慢性下腰痛（CLBP）的安全性和有效性。
20例有一个或两个节段症状性椎间盘的CLBP患者纳入研究。
主要安全终点为1个月时的严重不良事件，主要疗效终点为3个月时疼痛和功能障碍的减轻。次要疗效终点包括2周、1个月、6个月和12个月时疼痛和功能障碍的减轻；屈伸不稳定性的降低；节段性前凸和旋转的增加；以及患者满意度。
使用荧光透视影像引导，对每个症状性椎间盘进行两次经后外侧的缓冲京尼平注射。使用屈伸位X线片在三个时间点量化关节运动学。
在治疗后2周至1年，80%或更多的患者报告疼痛和功能障碍评分有临床意义的改善。对于更严重不稳定的关节，治疗显著降低了不稳定评分，从治疗前比无症状人群平均值高2.4个标准差的水平降至3个月随访时的无症状平均值。
这些初步临床数据证明了基于京尼平的胶原蛋白束缚装置的安全性和有效性，该装置能够改善脊柱关节稳定性，同时成功解决CLBP。这项工作值得进一步开展随机临床研究。
