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?
This will be an open-label, non-randomized 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. The adipose tissue specimen will be collected mainly from the patient's abdomen using a liposuction cannula. The adipose tissue may be collected from other areas if necessary The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred to an injection/infusion catheter for delivery into the akinetic myocardial scar in the region of a previous infarct
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The adipose tissue specimen will be collected mainly from the patient's abdomen using a liposuction cannula. The adipose tissue may be collected from other areas if necessary The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred to an injection/infusion catheter for delivery into the akinetic myocardial scar in the region of a previous infarct
Ageless Regenerative Institute LLC
Aventura, Florida, United States
Improved cardiac function
Improvement is observed in cardiac function as assessed by echocardiographic LV function (EF)
Time frame: 3 and 6 months after intervention
Adverse Event
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: Duration of study
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