Autologous olfactory ensheathing cell transplantation in human paraplegia: a 3-year clinical trial.
Autologous olfactory ensheathing cell transplantation in human paraplegia: a 3-year clinical trial.
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自体嗅觉分散细胞移植在人类瘫痪中：一项为期3年的临床试验。
DOI：
10.1093/brain/awn173
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发表时间：
2008-09
期刊：
影响因子：
--
通讯作者：
Geraghty T
中科院分区：
文献类型：
--
作者：
Mackay-Sim A;Féron F;Cochrane J;Bassingthwaighte L;Bayliss C;Davies W;Fronek P;Gray C;Kerr G;Licina P;Nowitzke A;Perry C;Silburn PA;Urquhart S;Geraghty T
嗅鞘细胞在临床前动物模型中显示出作为修复受损脊髓的细胞移植疗法的前景。这是一份将嗅鞘细胞自体移植到六名完全胸椎截瘫患者脊髓中的临床试验报告。我们之前报道了手术和移植的方法以及移植后一年试验的安全性。在这里，我们讨论了试验的总体设计和手术的安全性，并在移植手术后的 3 年内进行了评估。所有患者在进入试验时均接受评估，并在试验期间定期接受评估。临床评估包括医学、心理社会、放射学和神经学，以及神经和功能缺陷的专门测试（标准美国脊柱损伤协会和功能独立测量评估）。定量测试包括损伤水平以下感觉和运动功能的神经生理学测试。该试验为I/IIa期设计，主要目的是测试将自体嗅鞘细胞移植到人类截瘫患者受损脊髓中的可行性和安全性。该设计包括未接受手术的对照组，在其他方面与移植受者组密切匹配。该组作为评估者的对照，评估者对患者的治疗状态一无所知。对照组也提供了初步评估移植效果的机会。将嗅鞘细胞自体移植到移植前至少 2 年受损的脊髓中，3 年后没有发现不良结果。 3 年时的磁共振图像 (MRI) 显示与术前 MRI 或 1 年和 2 年的干预 MRI 相比没有变化，没有任何引入细胞肿瘤的证据，也没有出现创伤后脊髓空洞症或其他不良放射学发现。所有患者均未出现明显的功能变化，也没有神经性疼痛。在一名移植受者中，双侧、前侧和后侧的轻触和针刺敏感性有超过 3 个节段的改善。我们的结论是，将自体嗅鞘细胞移植到受伤的脊髓中是可行的，并且在植入后 3 年内是安全的，但是，由于试验患者数量较少，这一结论应被视为初步结论。
Olfactory ensheathing cells show promise in preclinical animal models as a cell transplantation therapy for repair of the injured spinal cord. This is a report of a clinical trial of autologous transplantation of olfactory ensheathing cells into the spinal cord in six patients with complete, thoracic paraplegia. We previously reported on the methods of surgery and transplantation and the safety aspects of the trial 1 year after transplantation. Here we address the overall design of the trial and the safety of the procedure, assessed during a period of 3 years following the transplantation surgery. All patients were assessed at entry into the trial and regularly during the period of the trial. Clinical assessments included medical, psychosocial, radiological and neurological, as well as specialized tests of neurological and functional deficits (standard American Spinal Injury Association and Functional Independence Measure assessments). Quantitative test included neurophysiological tests of sensory and motor function below the level of injury. The trial was a Phase I/IIa design whose main aim was to test the feasibility and safety of transplantation of autologous olfactory ensheathing cells into the injured spinal cord in human paraplegia. The design included a control group who did not receive surgery, otherwise closely matched to the transplant recipient group. This group acted as a control for the assessors, who were blind to the treatment status of the patients. The control group also provided the opportunity for preliminary assessment of the efficacy of the transplantation. There were no adverse findings 3 years after autologous transplantation of olfactory ensheathing cells into spinal cords injured at least 2 years prior to transplantation. The magnetic resonance images (MRIs) at 3 years showed no change from preoperative MRIs or intervening MRIs at 1 and 2 years, with no evidence of any tumour of introduced cells and no development of post-traumatic syringomyelia or other adverse radiological findings. There were no significant functional changes in any patients and no neuropathic pain. In one transplant recipient, there was an improvement over 3 segments in light touch and pin prick sensitivity bilaterally, anteriorly and posteriorly. We conclude that transplantation of autologous olfactory ensheathing cells into the injured spinal cord is feasible and is safe up to 3 years of post-implantation, however, this conclusion should be considered preliminary because of the small number of trial patients.
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影响因子：
6.2
作者：
DOUCETTE, R
通讯作者：
DOUCETTE, R
DOI：
10.1016/j.apmr.2004.03.015
发表时间：
2004-11-01
影响因子：
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作者：
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通讯作者：
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影响因子：
4.2
作者：
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通讯作者：
Dunlop, SA
影响因子：
14.5
作者：
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通讯作者：
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