Status:
COMPLETED
A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium
Lead Sponsor:
Cytori Therapeutics
Conditions:
Ischemic Heart Disease
Coronary Arteriosclerosis
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility...
Eligibility Criteria
Inclusion
- Key
- Able to provide written informed consent
- Males or females 20 to 75 years of age, inclusive
- Coronary artery disease not amenable to any type of revascularization procedure (percutaneous or surgical) in the target area
- Hemodynamic stability
- Ability to undergo liposuction
- Ability to walk on a treadmill
- Negative urine pregnancy test (females only).
- Key
Exclusion
- Unstable angina
- Serum creatinine \>2.5 mg/dL
- Planned or scheduled staged treatment of CAD or other interventional or surgical procedures
- Cardiogenic shock
- History of resuscitated sudden cardiac death; or symptomatic or sustained ventricular fibrillation or ventricular tachycardia.
- Vascular anatomy that precludes cardiac catheterization
- Peripheral artery disease that precludes insertion of an 8 Fr sheath
- Severe valvular disease
- Pregnant or nursing females
- Known and relevant allergies or sensitivities
- Life expectancy \<1 year
- Participation in any other clinical research study that has not reached its primary endpoint or otherwise would interfere with the subject's participation in this study
- Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00426868
Start Date
January 1 2007
End Date
March 1 2012
Last Update
August 28 2013
Active Locations (4)
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1
Rigshospitalet University Hospital
Copenhagen, Denmark
2
Erasmus University Medical Centrum, Thorax Center
Rotterdam, Netherlands
3
University of Utrecht Medical Center
Utrecht, Netherlands
4
Hospital General Universitario Gregorio Marañón
Madrid, Spain