This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
To assess the safety and efficacy of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
ADRCs processed by the Celution System for reintroduction into the myocardium
Physiological solution made of Lactated Ringers solution and a small amount (\<1mL) of autologous blood
University Hospital Case Medical Center
Cleveland, Ohio, United States
Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire
Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment.
Time frame: 6 months post treatment
Secondary Efficacy - Change in mVO2
Change in mVO2 at 6 months as assessed by Exercise Tolerance Test
Time frame: 6 months post treatment
Secondary Efficacy - Change in LVESV/LVEDV
Change in LVESV/LVEDV at 6 months as assessed by Echocardiography
Time frame: 6 months post treatment
Secondary Efficacy - Change in Ejection Fraction
Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography
Time frame: 6 months post treatment
Secondary Efficacy - Change in perfusion defect
Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT
Time frame: 6 months post treatment
Secondary Efficacy - Resource Utilization
Resource utilization - hospital length of stay, re-hospitalization for cardiac related events
Time frame: through 12 months post treatment
Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life
Change in heart failure symptoms, angina, and quality of life assessed by - NYHA classification, CCS classification, MLHFQ (other than 6 months)
Time frame: through 12 months post treatment
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