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A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00426868
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : August 28, 2013
Information provided by (Responsible Party):
Cytori Therapeutics

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 and have demonstrated reversible ischemia.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Coronary Arteriosclerosis Cardiovascular Disease Coronary Disease Coronary Artery Disease Other: Direct injection of ADRCs into the Left Ventricle Other: Direct injection of placebo into the Left Ventricle Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial
Study Start Date : January 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Other: Direct injection of ADRCs into the Left Ventricle
Dose escalation

Placebo Comparator: Placebo Other: Direct injection of placebo into the Left Ventricle

Primary Outcome Measures :
  1. Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) [ Time Frame: Up to 36 months ]

Secondary Outcome Measures :
  1. Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography [ Time Frame: Up to 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426868

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Rigshospitalet University Hospital
Copenhagen, Denmark
Erasmus University Medical Centrum, Thorax Center
Rotterdam, Netherlands
University of Utrecht Medical Center
Utrecht, Netherlands
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Sponsors and Collaborators
Cytori Therapeutics
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT00426868    
Other Study ID Numbers: PRECISE-01
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by Cytori Therapeutics:
Stem Cells
chronic ischemia
heart disease
coronary artery disease
inducible reversible ischemia
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases