BackgroundStromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue. The SVF contains a mixture of cells including ADSCs and growth factors and has been depleted of the adipocyte (fat cell) population. We evaluated the safety and efficacy of administering SVF intra-myocardially into patients with chronic ischemic cardiomyopathy.MethodsA total of 28 patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the akinetic myocardial scar region using a transendocardial delivery system (MyoCath®) in patients who had experienced a previous myocardial infarct. The subjects were then monitored for adverse events, ejection fraction via echocardiogram and six-minute walk test (6MWT) over a period of 6 months.ResultsThe average EF was 29 % at baseline and significantly increased to 35 % at both 3 and 6 months. Patients walked an average of 349 m at baseline and demonstrated a statistically significant improvement at 3 and 6 months’ post treatment of more than 80 m.ConclusionsOverall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy.Trial registration NCT01502514Name of registry: http://www.clinicaltrials.govURL: https://www.clinicaltrials.gov/ct2/show/NCT01502514?term=adipose+cells+heart&rank=4Date of registration: December 27, 2011Date of enrollment: January 2012
Critical limb ischemia (CLI) is a debilitating condition for which limited therapeutic options exist. Characterized by ischemia of the lower limb due to vascular deficiency, attempts have been made to stimulate angiogenesis utilizing cell and gene-based approaches. Adipose stromal vascular fraction (SVF) cells are a practical source of autologous tissue that can be prepared inexpensively in a same-day procedure. Recent studies have demonstrated SVF to be highly angiogenic, as well as clinically safe in a variety of contexts. Here, we describe the rationale and, to our knowledge, the first successful clinical implementation of autologous SVF cells for the treatment of a no-option CLI patient.
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