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Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Official title:
Phase I Clinical Study on the Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) Injection in Patients With Critical Limb Ischemia

Clinical Trial Summary

The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.

Clinical Trial Description

Critical limb ischemia (CLI) is a progressive disease, which arises as a result of atherosclerosis or vasculitis in leg arteries. Prognosis of CLI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the leg arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. The investigators will study the safety and clinical efficiency of vascular regeneration by means of transplantation of allogeneic Endothelial Progenitor Cells in patients with CLI who are not eligible for traditional revascularization treatments. The primary endpoint is the safety and tolerance identified by adverse events related with investigated drugï¼›while the secondary endpoints are evaluation of the preliminary efficacy of EPCs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06359912
Study type Interventional
Source Allife Medical Science and Technology Co., Ltd.
Contact Shaoying Lu, Dr
Phone 029-85323473
Email xjyfyllh@163.com
Status Recruiting
Phase Phase 1
Start date April 2024
Completion date July 2025
View Details
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