Imaging characteristics of chronic spinal cord injury identified during screening for a cell transplantation clinical trial
Imaging characteristics of chronic spinal cord injury identified during screening for a cell transplantation clinical trial
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DOI：
10.3171/2018.12.focus18593
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发表时间：
2019-03-01
影响因子：
4.1
通讯作者：
Levi, Allan D.
中科院分区：
文献类型：
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作者：
Burks, Joshua D.;Gant, Katie L.;Levi, Allan D.
目的在脊髓损伤（SCI）的细胞移植试验中，可量化的影像学标准作为入选标准在试验设计中非常重要。作者的机构经验表明，筛选失败率总体较高。作者在一项I期开放实验室临床试验中检查了试验排除的原因，该试验检查了自体雪旺细胞髓内移植的作用。具体来说，他们审查了慢性SCI患者的影像学特征，将申请人排除在试验之外，因为这是他们研究中筛选失败的常见原因。方法作者回顾了152例慢性（> 1年）SCI患者的MRI记录，这些患者自愿接受病灶内雪旺细胞移植，但被认为不符合前瞻性定义的标准。在T2加权MRI矢状面中，沿脊髓长轴沿着测量头尾侧损伤病变长度。其他病变的特点，特别是那些有关病变腔结构导致试验exclusion，recorded.Results成像记录从152个潜在的参与者慢性SCI进行了审查，42胸级SCI和110颈部水平SCI。根据影像学特征，23例（55%）胸SCI患者和70例（64%）颈SCI患者未入组本试验。对于不符合入组筛选标准的胸部损伤的潜在受试者，平均喙尾矢状病变长度为50 mm（SD 41 mm）。在申请人与颈椎损伤谁不符合筛选标准的登记，平均矢状病变长度为34毫米（SD 21毫米）。结论虽然筛选人与SCI参与细胞移植临床试验，病变长度或体积可以排除潜在的主题谁出现适当的候选人的基础上，神经系统的资格标准。在计划未来的细胞治疗试验时，由于筛选负担和对候选人选择的影响，应尽早考虑病变大小的限制。
OBJECTIVE In cell transplantation trials for spinal cord injury (SCI), quantifiable imaging criteria that serve as inclusion criteria are important in trial design. The authors' institutional experience has demonstrated an overall high rate of screen failures. The authors examined the causes for trial exclusion in a phase I, open-lab clinical trial examining the role of autologous Schwann cell intramedullary transplantation. Specifically, they reviewed the imaging characteristics in people with chronic SCI that excluded applicants from the trial, as this was a common cause of screening failures in their study.METHODS The authors reviewed MRI records from 152 people with chronic (> 1 year) SCI who volunteered for intra-lesional Schwann cell transplantation but were deemed ineligible by prospectively defined criteria. Rostral-caudal injury lesion length was measured along the long axis of the spinal cord in the sagittal plane on T2-weighted MRI. Other lesion characteristics, specifically those pertaining to lesion cavity structure resulting in trial exclusion, were recorded.RESULTS Imaging records from 152 potential participants with chronic SCI were reviewed, 42 with thoracic-level SCI and 110 with cervical-level SCI. Twenty-three individuals (55%) with thoracic SCI and 70 (64%) with cervical SCI were not enrolled in the trial based on imaging characteristics. For potential participants with thoracic injuries who did not meet the screening criteria for enrollment, the average rostral-caudal sagittal lesion length was 50 mm (SD 41 mm). In applicants with cervical injuries who did not meet the screening criteria for enrollment, the average sagittal lesion length was 34 mm (SD 21 mm).CONCLUSIONS While screening people with SCI for participation in a cell transplantation clinical trial, lesion length or volume can exclude potential subjects who appear appropriate candidates based on neurological eligibility criteria. In planning future cell-based therapy trials, the limitations incurred by lesion size should be considered early due to the screening burden and impact on candidate selection.