Clinical Recruitment: 45 Patients with Ischemic Stroke


2024-10-15

Currently, China's first Phase I/IIa clinical trial (ASSIST) using imported stem cells to treat ischemic stroke—led by Jiuzhitang Maker—is underway. We are now recruiting 45 patients with ischemic stroke to voluntarily participate in a Phase IIa clinical trial.

 

Project Overview

 

This is an evaluation of a single injection of ischemia-tolerant human allogeneic bone marrow in patients with ischemic stroke. Mesenchymal stem cells A Phase II, multicenter, double-blind, randomized, placebo-controlled study (ASSIST) evaluating the safety, tolerability, and preliminary efficacy of (itMSCs).

The study has been approved by the National Medical Products Administration and the ethics committees of all participating research centers. It is being conducted at three hospitals in Beijing and plans to enroll a total of 45 patients with ischemic stroke.

 

Recruitment Requirements

 

1. This study aims to evaluate the safety, tolerability, and clinical efficacy of ischemia-tolerant allogeneic bone marrow mesenchymal stem cells in treating patients with ischemic stroke.

2. Men and women aged 18 and older;

3. The medical history indicates that the most recent clinical diagnosis of ischemic stroke occurred more than 6 months ago.

4. There is severe neurological impairment, requiring assistance from others to walk or making it impossible to independently perform basic daily activities.

5, Other qualified physicians, based on their comprehensive assessment, have determined that you meet the study’s eligibility criteria—and provided the participant has given informed consent—you’re welcome to choose to participate in this research.

 

After screening, if you meet the criteria and are eligible to participate in the study, the study treatment medication and related examination costs will be covered by the sponsor.

 

Number of recruits

 

45 individuals

 

Center List and Contacts

 

For detailed information about the trial, please consult the study doctor during business hours, from 8:30 a.m. to 5:30 p.m.

 

Beijing Tiantan Hospital, Affiliated to Capital Medical University

Teacher Shao, 13292480903

 

Beijing Tongren Hospital, Affiliated to Capital Medical University

Teacher Guo, 17801546029

Teacher, 18801118775

 

Peking University Third Hospital

Teacher Liu, 15283103393