The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?
The primary objectives of this study are to evaluate in patients recovering from acute myocardial infarction (\< 8 days after the index infarction) both the safety profile of intramyocardial ASCs and the preliminary efficacy of ASCs therapy. This will be an open-label, non-randomized patient sponsored multi-center study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
This trial will study ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy
Ageless Institute
Miami, Florida, United States
Cardiac Improvement
Autologous ASCs therapy will be considered effective for post-myocardial infarction patients if there is an improvement in: * Absolute LVEF * Changes in LVEF from baseline to 6 months * MI size * Regional wall thickness and thickening in all segments * LV-end systolic volume (LV-ESV) * LV-end diastolic volume (LV-EDV) * Change in perfusion defect after revascularization to six months as measured by: * Echocardiography * Scintigraphy
Time frame: 6 months
Primary Safety Objective
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.