一项针对慢性胸段脊髓损伤的神经干细胞移植单中心1期研究的长期临床和安全性结果。
Long-term clinical and safety outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic thoracic spinal cord injury.
作者信息
Martin Joel R, Cleary Daniel, Abraham Mickey E, Mendoza Michelle, Cabrera Betty, Jamieson Catriona, Marsala Martin, Ciacci Joseph D
机构信息
Department of Neurological Surgery, University of California, San Diego, La Jolla, CA 92037, USA.
Department of Medicine, Division of Regenerative Medicine and CIRM Alpha Stem Cell Clinic, University of California, San Diego, La Jolla, CA 92037, USA.
出版信息
Cell Rep Med. 2024 Dec 17;5(12):101841. doi: 10.1016/j.xcrm.2024.101841. Epub 2024 Dec 2.
We report the long-term results for a phase 1 study of neural stem cell transplantation for chronic spinal cord injury. The trial was registered on ClinicalTrials.gov as NCT01772810. The primary outcome of the trial was to test the feasibility and safety of human spinal cord-derived neural stem cell (NSI-566) transplantation for the treatment of chronic spinal cord injury in four subjects with thoracic two to thoracic twelve spinal cord injury. Here, we report that all four subjects tolerated the stem cell implantation procedure well, and two subjects had durable electromyography-quantifiable evidence of neurological improvement as well as increased neurological motor and sensory scores at five years post-transplantation.
我们报告了一项关于神经干细胞移植治疗慢性脊髓损伤的1期研究的长期结果。该试验已在ClinicalTrials.gov上注册，编号为NCT01772810。该试验的主要结果是测试人脊髓源性神经干细胞（NSI-566）移植治疗4例胸2至胸12脊髓损伤的慢性脊髓损伤患者的可行性和安全性。在此，我们报告称，所有4例患者对干细胞植入手术耐受性良好，2例患者在移植后5年有持久的肌电图可量化的神经功能改善证据，以及神经运动和感觉评分增加。
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