Clinical Trial: Stem Cell Study for Patients With Leg Ulcer/Gangrene

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Crit

Brief 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 Summary: 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.
Sponsor: Translational Research Informatics Center, Kobe, Hyogo, Japan

Current Primary Outcome: Major amputation

Original Primary Outcome: Same as current

Current Secondary Outcome: Limb ischemia

Original Secondary Outcome: Same as current

Information By: Translational Research Informatics Center, Kobe, Hyogo, Japan

Dates:
Date Received: September 13, 2005
Date Started: November 2003
Date Completion:
Last Updated: February 6, 2009
Last Verified: February 2009