NCT05850208

Autologous Bone Marrow Mesenchymal Stem Cells (BMSCs) Transplantation in the Treatment of Ischemic Stroke

A Randomized, Open and Routine Parallel Controlled Clinical Study on the Safety and Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells (BMSCs) Transplantation in the Treatment of Ischemic Stroke

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluated the safety and efficacy of BMSCs transplantation in the treatment of ischemic stroke, so as to provide a basis for future clinical application of BMSCs transplantation in the treatment of ischemic stroke.

Detailed description

1. Routine treatment: 1.1. If arterial plaque is found, use lipid-lowering therapy (routine dose of atorvastatin or rosuvastatin). If no plaque is found, use atorvastatin or rosuvastatin based on the maintenance of normal blood lipid; 1.2. If venous thrombosis or arterial plaques are found in the lower limbs, use dabigatran to prevent platelet aggregation; if no vascular problems are found in the lower limbs, use aspirin or clopidogrel to prevent platelet aggregation; 1.3. During the treatment, cerebrovascular stenosis (non responsible vessels) can be treated intravascularly; 1.4. The use of neurotrophic drugs is prohibited during the study; 1.5. Elevated homocysteine was treated with mecobalamin and folic acid; 1.6. Hypertension, diabetes and other basic diseases receive routine treatment, and the combined medication is recorded in the case report form. 2. Grouping: 2.1. BMSCs group: BMSCs were transplanted on the basis of routine treatment: the transplanted cells were injected intravenously and transplanted in two times, with a dose of 1 × 106 / kg body weight, each volume of 80ml ± 5ml, and the time interval between two transplants was 1 week; 2.2. Routine treatment group: only receiving routine treatment;

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
BIOLOGICAL	Transplantation of self BMSCs	Bone marrow was collected, cultured in vitro and injected back into the body

Timeline

• Start date: 2022-02-23
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2023-05-09
• Last updated: 2023-05-09

Locations

1 site across 1 country: China