- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00426868
A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium
A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial
Study Overview
Status
Conditions
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 in this study. Eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRCs or placebo.
The outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 months post index procedure. Long Term Follow-up will be conducted at 12, 18, 24 and 36 months after the procedure.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Copenhagen, Denmark
- Rigshospitalet University Hospital
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Rotterdam, Netherlands
- Erasmus University Medical Centrum, Thorax Center
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Utrecht, Netherlands
- University of Utrecht Medical Center
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Madrid, Spain
- Hospital General Universitario Gregorio Marañon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Experimental: Treatment
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Dose escalation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Time Frame: Up to 36 months
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Up to 36 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography
Time Frame: Up to 36 months
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Up to 36 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alexander M Milstein, MD, Cytori Therapeutics, Inc
- Principal Investigator: Francisco J Fernández-Avilés, MD, PhD, FACC, FESC, Hospital G.U. Gregorio Marañón
- Principal Investigator: Emerson C Perin, MD, PhD, Texas Heart Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRECISE-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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