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

Sponsor:	Cytori Therapeutics
Information provided by:	Cytori Therapeutics
ClinicalTrials.gov Identifier:	NCT00426868

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 I

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:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

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 February 09, 2012