[Translation] A dose-escalating, single-center, open-label clinical study to evaluate the safety and tolerability of forebrain neural progenitor cell injection derived from human induced pluripotent stem cells in improving hemiplegic sequelae of ischemic stroke
主要研究目的:评价hNPC01细胞移植后6个月,改善缺血性脑卒中偏瘫后遗症的安全性和耐受性。
次要研究目的:评价hNPC01细胞移植后12个月,改善缺血性脑卒中偏瘫后遗症的安全性和耐受性;评估最大耐受剂量(Maximum Tolerated Dose, MTD)。
探索性研究目的:初步评价hNPC01改善缺血性脑卒中偏瘫后遗症的有效性;初步评价hNPC01改善缺血性脑卒中偏瘫后遗症的影像学改善。
[Translation] Main research purpose: To evaluate the safety and tolerability of hNPC01 cells in improving hemiplegic sequelae of ischemic stroke 6 months after transplantation.
Secondary research purposes: To evaluate the safety and tolerability of hNPC01 cells in improving hemiplegic sequelae of ischemic stroke 12 months after transplantation; to evaluate the maximum tolerated dose (Maximum Tolerated Dose, MTD).
Purpose of the exploratory study: to initially evaluate the effectiveness of hNPC01 in improving the sequelae of hemiplegia after ischemic stroke; to initially evaluate the imaging improvement of hNPC01 in improving the sequelae of hemiplegia after ischemic stroke.