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Clinical Trial
. 2016 Jun 2;14(1):158.
doi: 10.1186/s12967-016-0918-5.

Effects of the Intramyocardial Implantation of Stromal Vascular Fraction in Patients With Chronic Ischemic Cardiomyopathy

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Free PMC article
Clinical Trial

Effects of the Intramyocardial Implantation of Stromal Vascular Fraction in Patients With Chronic Ischemic Cardiomyopathy

K Comella et al. J Transl Med. .
Free PMC article

Abstract

Background: Stromal 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.

Methods: A 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.

Results: The 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.

Conclusions: Overall, 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 NCT01502514 Name of registry: http://www.clinicaltrials.gov URL: https://www.clinicaltrials.gov/ct2/show/NCT01502514?term=adipose+cells+heart&rank=4 Date of registration: December 27, 2011 Date of enrollment: January 2012.

Keywords: Adipose derived stromal/stem cells (ADSCs); Adipose tissue; Cell therapy; Connective tissue; Ischemic cardiomyopathy; Stem cells; Stromal vascular fraction (SVF).

Figures

Fig. 1
Fig. 1
a Adipogenesis fat differentiation (oil red-O), b Osteogenesis bone differentiation (alizarin red S), c Chondrogenic cartilage differentiation (toluidine blue sodium borate stain)
Fig. 2
Fig. 2
a Absolute left ventricular ejection fraction (LVEF), b Change in LVEF
Fig. 3
Fig. 3
a Six minute walk test (6MWT) in m, b Change in 6MWT
Fig. 4
Fig. 4
a Wall thickness (mm), b Change in wall thickness

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