Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage-colony stimulating factor: Phase I/II clinical trial
Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage-colony stimulating factor: Phase I/II clinical trial
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DOI：
10.1634/stemcells.2006-0807
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发表时间：
2007-08-01
期刊：
影响因子：
5.2
通讯作者：
Ha, Yoon
中科院分区：
文献类型：
--
作者：
Yoon, Seung Hwan;Shim, Yu Shik;Ha, Yoon
为评价自体骨髓细胞（BMC）移植联合粒细胞-巨噬细胞集落刺激因子（GM-CSF）治疗完全性脊髓损伤的安全性和疗效，对35例完全性脊髓损伤患者进行了I/II期、开放性、非随机研究。在损伤后14天内（n = 17）、14天至8周（n = 6）和超过8周（n = 12）通过注射将BMCs移植到脊髓损伤部位的周围区域。对照组13例，均行常规减压融合术，未行BMC移植。使用美国脊髓损伤协会损伤量表（AIS）、电生理监测和磁共振成像（MRI）对患者进行术前和随访神经系统评估。平均随访时间为10.4个月。4个月时，MRI分析显示脊髓增大，细胞植入部位轻微增强，无任何不良病变，如恶变、出血、新发囊肿或感染。此外，BMC移植和GM-CSF给药与增加发病率的任何严重不良临床事件无关。急性和亚急性治疗患者中有30.4%的AIS分级增加（AIS A至B或C），而慢性治疗组中未观察到显著改善。在治疗过程中增加的神经性疼痛和移植部位的肿瘤形成仍有待研究。其确切的疗效有待于长期、大规模、多中心的临床研究。
To assess the safety and therapeutic efficacy of autologous human bone marrow cell (BMC) transplantation and the administration of granulocyte macrophage-colony stimulating factor (GM-CSF), a phase I/II open-label and non-randomized study was conducted on 35 complete spinal cord injury patients. The BMCs were transplanted by injection into the surrounding area of the spinal cord injury site within 14 injury days (n = 17), between 14 days and 8 weeks (n = 6), and at more than 8 weeks (n = 12) after injury. In the control group, all patients (n = 13) were treated only with conventional decompression and fusion surgery without BMC transplantation. The patients underwent preoperative and follow-up neurological assessment using the American Spinal Injury Association Impairment Scale (AIS), electrophysiological monitoring, and magnetic resonance imaging (MRI). The mean follow-up period was 10.4 months after injury. At 4 months, the MRI analysis showed the enlargement of spinal cords and the small enhancement of the cell implantation sites, which were not any adverse lesions such as malignant transformation, hemorrhage, new cysts, or infections. Furthermore, the BMC transplantation and GM-CSF administration were not associated with any serious adverse clinical events increasing morbidities. The AIS grade increased in 30.4% of the acute and subacute treated patients (AIS A to B or C), whereas no significant improvement was observed in the chronic treatment group. Increasing neuropathic pain during the treatment and tumor formation at the site of transplantation are still remaining to be investigated. Long-term and large scale multicenter clinical study is required to determine its precise therapeutic effect.