The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Heart Disease as assessed by a series of measurements indicating improvement, stability, or degradation of a patient's cardiovascular function and exercise capacity?
This will be an open-label, non-randomized, multi-center patient-sponsored study designed to assess the safety and cardiovascular effects of Adipose-derived Stem Cell (ASC) implantation using a catheter delivery system in patients who have nonischemic congestive heart failure. A percutaneous transluminal endomyocardial injection catheter will be used for delivery of ASCs. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Local liposuction procedure to harvest the fat tissue. Adipose Derived Stem Cells are then implanted via intramyocardial and intravenous injection.
Instituto de Medicina Regenerativa
Tijuana, Estado de Baja California, Mexico
Improvement in 6 minute walk test
compared to baseline
Time frame: 3 months
Minnesota Living with Heart Failure Quality of Life Questionnaire
Time frame: 3 months
Improvement in 6 minute walk test
Time frame: 6 months
Minnesota Living with Heart Failure Quality of Life Questionnaire
Time frame: 6 months
Number of Adverse Events
Time frame: 6 months
Improvement in New York Heart Association (NYHA) classification
Time frame: 3 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Determined by and echo
Time frame: 3 months
Improvement in the Left Ventricular (LV) Volume
Determined by an echo
Time frame: 3 months
Improvement in New York Heart Association (NYHA) classification
Time frame: 6 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Time frame: 6 months
Improvement in the Left Ventricular (LV) Volume
Time frame: 6 months
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