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Sponsors and Collaborators: |
Translational Research Informatics Center, Kobe, Hyogo, Japan Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan Kobe City General Hospital |
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Information provided by: | Translational Research Informatics Center, Kobe, Hyogo, Japan |
ClinicalTrials.gov Identifier: | NCT00221143 |
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.
Condition | Intervention | Phase |
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Leg Pain Ulcer Gangrene Ischemia Peripheral Vascular Diseases |
Genetic: Autologous peripheral blood CD34 positive cell therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study |
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 |
Enrollment: | 15 |
Study Start Date: | November 2003 |
Study Completion Date: | January 2008 |
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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Chronic severe CLI patients fulfilling all the following criteria are considered suitable for inclusion in the study.
Exclusion Criteria:
Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
Japan, Hyogo | |
Institute of Biomedical Research and Innovation | |
Kobe, Hyogo, Japan, 650-0047 | |
Kobe City General Hospital | |
Kobe, Hyogo, Japan, 650-0046 |
Principal Investigator: | Takayuki Asahara, M.D. | Kobe Institute of Biomedical Research and Innovation |
Responsible Party: | Institute of Biomedical Research and Innovation ( Atsuhiko Kawamoto, MD, PhD Senior Research Scientist, Stem Cell Translational research Team ) |
Study ID Numbers: | BRI ASO 03-01 |
Study First Received: | September 13, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00221143 History of Changes |
Health Authority: | Japan: Foundation for Biomedical Research and Innovation |
Ulcer/ gangrene Leg diseases Pain Vascular diseases |
Chronic limb ischemia Peripheral artery disease Ulcer/ gangrene |
Necrosis Peripheral Vascular Diseases Ulcer Vascular Diseases |
Gangrene Pain Ischemia Leg Ulcer |
Necrosis Pathologic Processes Peripheral Vascular Diseases Ulcer |
Vascular Diseases Gangrene Cardiovascular Diseases Ischemia |