[Translation] A dose-escalation, single-center, open-label clinical study to evaluate the safety and tolerability of human induced pluripotent stem cell-derived forebrain neural progenitor cell injection to improve the sequelae of hemiplegia after 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] Primary study objective: To evaluate the safety and tolerability of hNPC01 cells in improving the sequelae of hemiplegia after ischemic stroke 6 months after transplantation.
Secondary study objective: To evaluate the safety and tolerability of hNPC01 cells in improving the sequelae of hemiplegia after ischemic stroke 12 months after transplantation; to assess the maximum tolerated dose (MTD).
Exploratory study objective: To preliminarily evaluate the effectiveness of hNPC01 in improving the sequelae of hemiplegia after ischemic stroke; to preliminarily evaluate the imaging improvement of hNPC01 in improving the sequelae of hemiplegia after ischemic stroke.