Mendonça Marcus Vinícius Pinheiro, Larocca Ticiana Ferreira, de Freitas Souza Bruno Solano, Villarreal Cristiane Flora, Silva Luiz Flávio Maia, Matos André Costa, Novaes Marco Antonio, Bahia Cláudia Maria Pinheiro, de Oliveira Melo Martinez Ana Carine, Kaneto Carla Martins, Furtado Sissi Brandão Carneiro, Sampaio Geraldo Pedral, Soares Milena Botelho Pereira, dos Santos Ricardo Ribeiro
Stem Cell Res Ther. 2014 Nov 17;5(6):126. doi: 10.1186/scrt516.
The administration of stem cells holds promise as a potential therapy for spinal cord injury (SCI). Mesenchymal stem cells have advantages for clinical applications, since they can be easily obtained, are suitable for autologous transplantation and have been previously shown to induce regeneration of the spinal cord in experimental settings. Here we evaluated the feasibility, safety and potential efficacy of autologous transplantation of mesenchymal stem cells in subjects with chronic complete SCI.
We conducted a phase I, non-controlled study in 14 subjects of both genders aging between 18 to 65 years, with chronic traumatic SCI (>6 months), at thoracic or lumbar levels, classified as American Spinal Injury Association (ASIA) A - complete injury. Baseline somatosensory evoked potentials (SSEP), spinal magnetic resonance imaging (MRI) and urodynamics were assessed before and after treatment. Pain rating was performed using the McGill Pain Questionnaire and a visual analogue score scale. Bone marrow-derived mesenchymal stem cells were cultured and characterized by flow cytometry, cell differentiation assays and G-band karyotyping. Mesenchymal stem cells were injected directly into the lesion following laminectomy and durotomy.
Cell transplantation was an overall safe and well-tolerated procedure. All subjects displayed variable improvements in tactile sensitivity and eight subjects developed lower limbs motor functional gains, principally in the hip flexors. Seven subjects presented sacral sparing and improved American Spinal Injury Association impairment scale (AIS) grades to B or C - incomplete injury. Nine subjects had improvements in urologic function. One subject presented changes in SSEP 3 and 6 months after mesenchymal stem cells transplantation. Statistically significant correlations between the improvements in neurological function and both injury size and level were found.
Intralesional transplantation of autologous mesenchymal stem cells in subjects with chronic, complete spinal cord injury is safe, feasible, and may promote neurological improvements.
ClinicalTrials.gov NCT01325103 - Registered 28 March 2011.
干细胞治疗有望成为脊髓损伤（SCI）的一种潜在疗法。间充质干细胞具有临床应用优势，因为它们易于获取，适合自体移植，并且先前已在实验环境中显示可诱导脊髓再生。在此，我们评估了自体间充质干细胞移植在慢性完全性脊髓损伤患者中的可行性、安全性和潜在疗效。
我们对14名年龄在18至65岁之间、患有慢性创伤性脊髓损伤（>6个月）、损伤部位在胸段或腰段且被美国脊髓损伤协会（ASIA）评定为A - 完全损伤的男女受试者进行了一项I期非对照研究。在治疗前后评估基线体感诱发电位（SSEP）、脊髓磁共振成像（MRI）和尿动力学。使用麦吉尔疼痛问卷和视觉模拟评分量表进行疼痛评分。通过流式细胞术、细胞分化测定和G带核型分析对骨髓来源的间充质干细胞进行培养和鉴定。在椎板切除术和硬脊膜切开术后，将间充质干细胞直接注入损伤部位。
细胞移植总体上是安全且耐受性良好的程序。所有受试者的触觉敏感性均有不同程度的改善，8名受试者下肢运动功能得到改善，主要是髋部屈肌。7名受试者出现骶部保留，美国脊髓损伤协会损伤量表（AIS）等级提高到B或C - 不完全损伤。9名受试者的泌尿功能有所改善。1名受试者在间充质干细胞移植后3个月和6个月时SSEP出现变化。发现神经功能改善与损伤大小和水平之间存在统计学上的显著相关性。
在慢性完全性脊髓损伤患者中进行损伤部位自体间充质干细胞移植是安全、可行的，并且可能促进神经功能改善。
ClinicalTrials.gov NCT01325103 - 于2011年3月28日注册
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