Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00221143
Study type Interventional
Source Translational Research Informatics Center, Kobe, Hyogo, Japan
Contact
Status Completed
Phase Phase 1/Phase 2
Start date November 2003
Completion date January 2008

See also
  Status Clinical Trial Phase
Recruiting NCT05443061 - Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children N/A
Recruiting NCT05158257 - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity N/A
Recruiting NCT06006975 - Early Warning of Delayed Cerebral Ischemia
Completed NCT02758847 - Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Completed NCT02557282 - CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol
Enrolling by invitation NCT02033681 - Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution N/A
Completed NCT01608035 - Sciatic Perineural Versus Stump Catheter for Below Knee Amputation Phase 0
Active, not recruiting NCT01518842 - Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy N/A
Completed NCT01625832 - Effects of Coronary Sinus Occlusion on Myocardial Ischemia (Pilot Study) N/A
Active, not recruiting NCT01281241 - Study on Mechanical and Electrical Alternans N/A
Completed NCT00778323 - Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery Phase 1/Phase 2
Completed NCT00371371 - Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI) Phase 1/Phase 2
Terminated NCT00760708 - Circulating Adenosine Levels Before and After Intravenous (IV) Persantine
Not yet recruiting NCT06039748 - Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
Completed NCT04879875 - New Method for Real-time Detection of Tissue Ischemia (ISCALERT) N/A
Completed NCT00526474 - Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737) Phase 3
Completed NCT03994822 - pRESET for Occlusive Stroke Treatment N/A
Completed NCT02910778 - The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males Phase 4
Completed NCT02552498 - Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging N/A