Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy

Abstract

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

Concise Review: A Safety Assessment of Adipose-Derived Cell Therapy in Clinical Trials: A Systematic Review of Reported Adverse Events

“…Almost all organ system have been implicated in adipose‐derived cell therapy. The indication for treatment in the included studies was (in order count) soft tissue , gastrointestinal , musculoskeletal , rheumatological , ulcer/ischemic limb , urogenital , cardiac , neurological , immunological , pulmonary , and ophthalmological (Fig. A).…”

Stem Cell Therapy in Heart Diseases – Cell Types, Mechanisms and Improvement Strategies

“…These freshly isolated cells obtained from adipose tissue by enzymatic or non-enzymatic dissociation are also termed stroma vascular fraction (SVF) and comprise a heterogeneous mixture containing ASCs, endothelial (progenitor) cells, blood cells, pericytes and other cell types [166]. Since then, other phase I and II clinical studies confirmed the safety and usability of these cells [167][168][169]. However, the two largest placebo-controlled clinical trials, including 27 and 31 patients respectively, failed to detect significant changes in LV functions or volumes after the transplantation of adipose-derived cells, although an improvement in maximal oxygen consumption was observed [167,168].…”

Intra-Articular Implantation of Stromal Vascular Fraction Plus Platelet Rich Plasma in a Degenerative Meniscal Injury

“…Fat tissue can be easily and safely harvested and SVF can be collected bedside making it an attractive therapeutic option for physicians to offer to their patients [19]. A variety of publications have reported on the injection of SVF including: osteoarthritis [20, -21], degenerative disc disease [22], sclerosis [23], tendinopathy [24], congestive heart failure [25], chronic obstructive pulmonary disease (COPD) [26], radiation necrosis [27], xerostomia [28], psoriasis [29], and multiple sclerosis [30].…”