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Sponsors and Collaborators: |
Case Western Reserve University University Hospitals of Cleveland Arteriocyte, Inc. |
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Information provided by: | Case Western Reserve University |
ClinicalTrials.gov Identifier: | NCT00365326 |
This phase I clinical trial will evaluate the safety and efficacy of intra-coronary injection of AC133 selected autologous marrow-derived stem cells in patients with chronic coronary artery occlusion. A clinical study to determine the therapeutic potential of marrow-derived stem cells as an adjunct therapy to current standard therapies for CAD is warranted. The current initiative is to investigate a model of chronic myocardial ischemia and (1) to determine whether intra-coronary injection of selected autologous marrow-derived AC133 stem cells is reasonably safe for use in humans and (2) if this treatment shows any improvement in coronary perfusion, as assessed using non-invasive imaging. This study is structured to evaluate the feasibility and safety of autologous AC133+ bone marrow-derived stem cell via intra-coronary injection into documented ischemic but viable myocardial zones via established collateral vessels. The epicardial vessel that normally supplies the ischemic zone must be 100% chronically occluded and considered non-revascularizable by percutaneous means.
Condition | Intervention | Phase |
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Coronary Occlusion |
Procedure: catheter-based intracoronary injection |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Autologous, Intracoronary Stem Cell Injections in Total Coronary Artery Occlusions |
Estimated Enrollment: | 10 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | September 2007 |
This study is composed of one phase. The objective of Phase I is to assess the safety and feasibility of performing escalating doses of autologous AC133+ selected bone marrow-derived stem cell with intracoronary infusion via epicardial vessels supplying collateral flow to areas of viable ischemic myocardium in the distribution of a chronic totally occluded vessel. Additionally, focus on the assessment of the benefit achieved from the infusion of stem cells and subsequent angiogenesis at 6 months will be observed.
Potential candidates are patients with a known total occlusion of an epicardial vessel, with a documented chronically ischemic territory supplied by collateral conduits.
Secondary Objectives include:
Major adverse cardiac events (MACE) assessment (composite endpoint including cardiac death, myocardial infarction, ischemia-driven target vessel revascularization, CABG, CVA, and rehospitalization for angina), MACE definitions:
Myocardial Infarction (All ST segment elevation MIs as diagnosed on electrocardiogram by a staff cardiologist and all non-ST segment elevation MIs as defined by elevation in cardiac enzyme markers per the hospital laboratory guidelines) Cerebral Vascular Accidents (e.g., acute neurological event).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria will be excluded from the study:
Contact: Don Brown | (617) 794-2711 | dbrown@arteriocyte.com |
United States, Ohio | |
Case Western Reserve University | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Principal Investigator: Dale Adler, MD | |
Sub-Investigator: Hillard Lazarus, MD |
Principal Investigator: | Dale Adler, MD | Case Western Reserve University |
Principal Investigator: | Hillard Lazarus, MD | Case Western Reserve University |
Study ID Numbers: | HFM-705 |
Study First Received: | August 15, 2006 |
Last Updated: | August 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00365326 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
AC133 coronary bone marrow autologous coronary artery disease |
Coronary Occlusion Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Coronary Artery Disease |
Cardiovascular Diseases |