Acute Myocardial Infarction Clinical Trial
Official title:
An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Autologous Adipose-Derived Stromal Cells Implantation by a Catheter Delivery System and/or Intravenously In Patients During the Acute Recovery Phase of ST-Elevation Myocardial Infarction
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.
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