[Translation] A Phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of intravenous injection of human umbilical cord CD146 mesenchymal stem cells in patients with ischemic stroke in an open-label, single-arm setting.
1. 主要目的:评价人脐带CD146间充质干细胞注射液经静脉途径治疗缺血性脑卒中参与者的安全耐受性,探索人脐带 CD146 间充质干细胞注射液对缺血性脑卒中参与者的最大耐受剂量(MTD)或剂量限制毒性(DLT)。
2. 次要目的:评价人脐带CD146间充质干细胞注射液经静脉途径治疗缺血性脑卒中参与者的初步有效性,采用 NIHSS 评分等对参与者
有效性进行评估,并为后续确证阶段临床试验试验药物剂量的选择提供依据。
[Translation] 1. Primary Objective: To evaluate the safety and tolerability of intravenous human umbilical cord CD146 mesenchymal stem cell injection in participants with ischemic stroke, and to explore the maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) of human umbilical cord CD146 mesenchymal stem cell injection in participants with ischemic stroke.
2. Secondary Objective: To evaluate the preliminary efficacy of intravenous human umbilical cord CD146 mesenchymal stem cell injection in participants with ischemic stroke, using NIHSS scores and other methods to assess efficacy, and to provide a basis for selecting the investigational drug dosage in subsequent confirmatory clinical trials.