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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Cytori Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT00426868
First received: January 23, 2007
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cytori Therapeutics:

Primary Outcome Measures:
  • Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) [ Time Frame: Up to 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2007
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426868

Locations
Denmark
Rigshospitalet University Hospital
Copenhagen, Denmark
Netherlands
Erasmus University Medical Centrum, Thorax Center
Rotterdam, Netherlands
University of Utrecht Medical Center
Utrecht, Netherlands
Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Sponsors and Collaborators
Cytori Therapeutics
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
  More Information

No publications provided

Responsible Party: Amanda Lehr, Clinical Program Manager, Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT00426868     History of Changes
Other Study ID Numbers: PRECISE-01
Study First Received: January 23, 2007
Last Updated: May 13, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Cytori Therapeutics:
ADRC
Stem Cells
chronic ischemia
 heart disease
coronary artery disease
inducible reversible ischemia

Additional relevant MeSH terms:
Arteriosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
 Heart Diseases
Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013