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 experienced myocardial infarction. 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 will be performed to harvest the fat. The Adipose Derived Stem Cells will be implanted via intramyocardial injection and intravenously.
Instituto de Medicina Regenerativa
Tijuana, Estado de Baja California, Mexico
Improvement in 6 Minute Walk Test
Time frame: 3 months
Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire
Time frame: 3 months
Improvement in 6 Minute Walk Test
Time frame: 6 months
Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire
Time frame: 6 months
Improvement in New York Heart Association classification
Time frame: 3 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Determined by an echo
Time frame: 3 months
Improvement inn the Left Ventricular Volume
Time frame: 3 months
Improvement in New York Heart Association classification
Time frame: 6 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Time frame: 6 months
Improvement in the Left Ventricular Volume
Time frame: 6 months
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