NCT00221143

Stem Cell Study for Patients With Leg Ulcer/Gangrene

Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Critical Limb Ischemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with 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.

Detailed description

Chronic critical limb ischemia (CLI) is a progressive disease, which arises as a result of atherosclerosis or vasculitis in leg arteries. Prognosis of chronic 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. We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells (CD34 positive cells) in patients with chronic CLI who are not eligible for traditional revascularization treatments. The primary endpoint is the primary efficacy score identified by toe brachial blood pressure index (TBPI), absolute claudication distance (ACD) and Wong Baker's pain rating scale, while the secondary endpoints are evaluation of safety, ankle brachial blood pressure index (ABPI), percutaneous tissue oxygen pressure (TcPO2), etc.

Conditions

• Leg Pain
• Ulcer
• Gangrene
• Ischemia
• Peripheral Vascular Diseases

Interventions

Type	Name	Description
GENETIC	Autologous peripheral blood CD34 positive cell therapy

Timeline

• Start date: 2003-11-01
• Completion: 2008-01-01
• First posted: 2005-09-22
• Last updated: 2009-02-09

Locations

2 sites across 1 country: Japan