A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium
NCT00426868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2013-08-28
Summary
The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived Stem \& Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia.
Conditions
- Ischemic Heart Disease
- Coronary Arteriosclerosis
- Cardiovascular Disease
- Coronary Disease
- Coronary Artery Disease
Interventions
- OTHER
-
Direct injection of ADRCs into the Left Ventricle
Dose escalation
- OTHER
-
Direct injection of placebo into the Left Ventricle
Sponsors & Collaborators
-
Cytori Therapeutics
lead INDUSTRY
Principal Investigators
-
Alexander M Milstein, MD · Cytori Therapeutics, Inc
-
Francisco J Fernández-Avilés, MD, PhD, FACC, FESC · Hospital G.U. Gregorio Marañón
-
Emerson C Perin, MD, PhD · Texas Heart Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2012-03-31
- Completion
- 2012-03-31
Countries
- Denmark
- Netherlands
- Spain
Study Locations
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