Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221143
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2005-09-13
Brief Title:
Stem Cell Study for Patients With Leg UlcerGangrene
Sponsor:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Organization:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Study Overview
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 Critical Limb Ischemia
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if stem cell therapy with ones own cells autologous cells delivered intramuscularly to ones leg with ulcer andor gangrene due to poor blood flow will be safe and if it will relieve leg pain increase blood flow andor 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 Bakers pain rating scale while the secondary endpoints are evaluation of safety ankle brachial blood pressure index ABPI percutaneous tissue oxygen pressure TcPO2 etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None