Cardiovascular Disease, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Disease, Ischemic Heart Disease
Conditions
Keywords
ADRC, Stem Cells, chronic ischemia, heart disease, coronary artery disease, inducible reversible ischemia
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.
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.
Interventions
OTHERDirect injection of ADRCs into the Left Ventricle
Dose escalation
OTHERDirect injection of placebo into the Left Ventricle
Sponsors
Cytori Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) | Up to 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography | Up to 36 months |
Countries
Denmark, Netherlands, Spain
Outcome results
None listed