[Translation] A multicenter, double-blind, randomized, placebo-controlled phase I clinical study to evaluate the safety and tolerability of allogeneic endothelial progenitor cells (EPCs) injection in the treatment of acute ischemic stroke patients
主要研究目的:
评价EPCs治疗急性缺血性脑卒中患者的安全性和耐受性,以及为后续临床研究推荐剂量。
次要研究目的:
1.评价EPCs治疗急性缺血性脑卒中患者的免疫原性;
2.评估EPCs治疗急性缺血性脑卒中患者的药物代谢动力学特征;
3.探索EPCs治疗急性缺血性脑卒中患者的剂量与临床疗效的效应关系;
4.观察EPCs治疗急性缺血性脑卒中患者的初步疗效。
探索性研究目的:
探索EPCs治疗急性缺血性脑卒中患者的药效学特征。
[Translation] Main research objectives:
To evaluate the safety and tolerability of EPCs in the treatment of patients with acute ischemic stroke, and to recommend doses for subsequent clinical studies.
Secondary research objectives:
1. To evaluate the immunogenicity of EPCs in the treatment of patients with acute ischemic stroke;
2. To evaluate the pharmacokinetic characteristics of EPCs in the treatment of patients with acute ischemic stroke;
3. To explore the relationship between the dose and clinical efficacy of EPCs in the treatment of patients with acute ischemic stroke;
4. To observe the preliminary efficacy of EPCs in the treatment of patients with acute ischemic stroke.
Exploratory research objectives:
To explore the pharmacodynamic characteristics of EPCs in the treatment of patients with acute ischemic stroke.