Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC.
Department of Bioinformatics and Medical Engineering, Asia University, Taichung, Taiwan, ROC.
J Tissue Eng Regen Med. 2022 Jan;16(1):3-13. doi: 10.1002/term.3256. Epub 2021 Oct 21.
Current therapy does not provide significant benefits for patients with chronic stroke. Pre-clinical studies suggested that autologous adipose-derived stem cells have benefits for the treatment of chronic stroke. This Phase I open-label study was conducted to demonstrate the safety and efficacy of autologous adipose-derived stem cells (GXNPC1) in chronic stroke. Three patients with chronic stroke were treated with stereotactic implantation of autologous adipose-derived stem cells (1 × 10 cells). The primary endpoints of safety evaluation included adverse events, over a 6 months post-implantation period. The secondary endpoints included improvements in neurological functions. Evolutional change of brain parenchyma was also followed with magnetic resonance imaging (MRI). All three participants improved significantly at 6 months follow-up. The extent of improvement from pre-treatment was: National Institutes of Health Stroke Scale improved 5-15 points, Barthel Index: 25-50 points, Berg balance scale 0-21 points and Fugl-Meyer modified sensation 3-28 points. All three patients had signal change along the implantation tract on MRI one month after surgery. There is no related safety issue through 6 months observation. Clinical measures of neurological symptoms of these patients with chronic stroke improved at 6 months without adverse effects after implantation of autologous adipose-derived stem cells (GXNPC1), which might be correlated with post-implantation changes on brain MRI. Clinical Trial Registration-URL: https://clinicaltrials.gov/ct2/show/NCT02813512?term=ADSC&cond=Stroke&cntry=TW&draw=2&rank=1 Unique identifier: NCT02813512.
目前的治疗方法并不能为慢性中风患者带来显著的益处。临床前研究表明，自体脂肪来源干细胞有益于慢性中风的治疗。这项 I 期开放标签研究旨在证明自体脂肪来源干细胞（GXNPC1）治疗慢性中风的安全性和有效性。3 名慢性中风患者接受了自体脂肪来源干细胞（1×10 个细胞）的立体定向植入治疗。安全性评估的主要终点包括植入后 6 个月内的不良事件。次要终点包括神经功能的改善。还通过磁共振成像（MRI）跟踪脑实质的演变变化。所有 3 名参与者在 6 个月的随访中均有显著改善。从治疗前到治疗后的改善程度为：国立卫生研究院中风量表改善 5-15 分，巴氏指数：25-50 分，伯格平衡量表 0-21 分，Fugl-Meyer 改良感觉 3-28 分。所有 3 名患者在手术后 1 个月 MRI 上均显示沿植入轨迹的信号变化。在 6 个月的观察期内没有发现相关的安全问题。这些慢性中风患者的神经症状的临床测量在 6 个月时得到改善，并且在植入自体脂肪来源干细胞（GXNPC1）后没有不良反应，这可能与 MRI 上的植入后变化有关。临床试验注册网址：https://clinicaltrials.gov/ct2/show/NCT02813512?term=ADSC&cond=Stroke&cntry=TW&draw=2&rank=1 独特标识符：NCT02813512。
