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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial

Conditions
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Ischemic Heart Disease, Coronary Arteriosclerosis, Cardiovascular Disease, Coronary Disease, Coronary Artery Disease

Intervention / Treatment
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* Other: Direct injection of ADRCs into the Left Ventricle
* Other: Direct injection of placebo into the Left Ventricle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Other: Direct injection of ADRCs into the Left Ventricle<br>* Dose escalation<br>|
| Placebo Comparator: Placebo<br> | Other: Direct injection of placebo into the Left Ventricle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) |  | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography |  | Up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADRC, Stem Cells, chronic ischemia, heart disease, coronary artery disease, inducible reversible ischemia