[Translation] A multi-center, double-blind, randomized, placebo-controlled phase I clinical study evaluating the safety and tolerability of allogeneic endothelial progenitor cell (EPCs) injection in the treatment of patients with acute ischemic stroke
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 purposes:
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 purposes:
1. Evaluate the immunogenicity of EPCs in the treatment of patients with acute ischemic stroke;
2. Evaluate the pharmacokinetic characteristics of EPCs in patients with acute ischemic stroke;
3. To explore the effect relationship between the dosage 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.
Purpose of exploratory research:
To explore the pharmacodynamic characteristics of EPCs in the treatment of patients with acute ischemic stroke.