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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 Okayama University |
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Information provided by: | Translational Research Informatics Center, Kobe, Hyogo, Japan |
ClinicalTrials.gov Identifier: | NCT00221182 |
The purpose of this study is to determine if stem cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain, increase the blood flow, and/or improve the cardiac contractility (function) by regenerating blood vessels in your heart.
Condition | Intervention | Phase |
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Chest Pain Chronic Myocardial Ischemia Coronary Artery Disease Angina Myocardial Infarction |
Genetic: Autologous peripheral blood CD34 positive cell therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/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 Myocardial Ischemia |
Estimated Enrollment: | 10 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2009 |
Chronic myocardial ischemia (MI) is a progressive disease, which arises as a result of atherosclerosis in coronary arteries. Prognosis of chronic MI 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 coronary 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 severe chronic coronary artery disease (CAD) who are not eligible for traditional revascularization treatments. The primary endpoint is the severity of myocardial ischemia identified by sestamibi SPECT stress myocardial scintigraphy and the evaluation of adverse effect rates, while the secondary endpoints are evaluation of CCSAS and NYHA classification, regional myocardial blood flow as revealed by PET scan, and various left ventricular function indices.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-Chronic severe CAD patients fulfilling all the following criteria are considered suitable for inclusion in the study.
Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
Exclusion Criteria:
Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
Contact: Atsuhiko Kawamoto, M.D. | +81-78-304-5772 | akawamoto@cdb.riken.jp |
Japan | |
Okayama University School of Medicine | Recruiting |
Okayama, Japan, 700-8530 | |
Contact: Kengo Kusano, MD +81-86-235-7351 k-kusano@md.okayama-u.ac.jp | |
Principal Investigator: Toru Ohe, MD | |
Sub-Investigator: Kengo Kusano, MD | |
Japan, Hyogo | |
Kobe City General Hospital | Recruiting |
Kobe, Hyogo, Japan | |
Contact: Yasuki Kihara, MD | |
Contact: Makoto Kinoshita, MD | |
Principal Investigator: Yasuki Kihara, MD | |
Sub-Investigator: Makoto Kinoshita, MD | |
Japan, Hyogo-Pref. | |
Kobe Institute of Biomedical Research and Innovation | Recruiting |
Kobe, Hyogo-Pref., Japan, 650-0047 | |
Contact: Atsuhiko Kawamoto, M.D. +81-78-306-1700 akawamoto@cdb.riken.jp | |
Principal Investigator: Atsuhiko Kawamoto, M.D. | |
Sub-Investigator: Minako Katayama, M.D. |
Principal Investigator: | Takayuki Asahara, M.D. | Foundation for Biomedical Research and Innovation |
Study ID Numbers: | BRI CAD 04-01 |
Study First Received: | September 13, 2005 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00221182 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Angina Heart diseases Pain Vascular diseases |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Angina Pectoris Pain Ischemia Arteriosclerosis |
Chest Pain Coronary Disease Signs and Symptoms Necrosis Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Pain Ischemia Arteriosclerosis Chest Pain |
Coronary Disease Signs and Symptoms Necrosis Pathologic Processes Cardiovascular Diseases Infarction Myocardial Infarction Coronary Artery Disease |