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

Cytori Therapeutics

Status and phase

Completed

Phase 1

Conditions

Coronary Artery Disease

Ischemic Heart Disease

Coronary Arteriosclerosis

Coronary Disease

Cardiovascular Disease

Treatments

Other: Direct injection of ADRCs into the Left Ventricle

Other: Direct injection of placebo into the Left Ventricle

Study type

Interventional

Funder types

Industry

Identifiers

NCT00426868

PRECISE-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.