医学
干细胞
磁共振成像
不利影响
临床试验
移植
临床终点
慢性中风
脂肪组织
中风恢复
外科
内科学
冲程(发动机)
物理疗法
放射科
康复
遗传学
工程类
生物
机械工程
作者
Ted H. Chiu,Rathinasamy Baskaran,Shen Kou Tsai,Chih‐Yang Huang,Ming‐Hsi Chuang,Wan-Sin Syu,Horng‐Jyh Harn,Yi‐Chun Lin,Chun‐Hung Chen,Pi-Chun Huang,Yifen Wang,Chi‐Hsuan Chuang,Po Ting Lin,Shinn‐Zong Lin
摘要
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 × 108 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.
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