High Doses of Vascular Endothelial Growth Factor 165 Safely, but Transiently, Improve Myocardial Perfusion in No-Option Ischemic Disease

Giusti, Imarilde; Rodrigues, Clarissa Garcia; Salles, Felipe Borsu de; Sant’Anna, Roberto T.; Eibel, Bruna; Han, Sang Won; Ludwig, Eduardo; Grossman, Gabriel Blacher; Prates, Paulo R.; Sant'Anna, João Ricardo M; Filho, Guaracy F Teixeira; Markoski, Melissa Medeiros; Nesralla, Ivo A.; Nardi, Nance Beyer; Kalil, Renato A. K.

doi:10.1089/hgtb.2012.221

Cited by 23 publications

(9 citation statements)

References 19 publications

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“…In one phase 2 study of 13 patients, myocardial injection of a VEGF 165 plasmid demonstrated improvements with several outcomes over the standard optimal therapy, including benefits to quality of life, improved angina, and decrease in ischemic segments. However, while some of these benefits were maintained over the course of the study, myocardial perfusion progressively returned to pre-treatment conditions over the 6 and 12 month follow-ups [258]. In an additional clinical study of 93 patients with class 3 or 4 conditions (as determined by the Canadian Cardiovascular Society), there were no significant differences between high dose injections of VEGF1 65 plasmid DNA over placebo [259].…”

Section: Clinical Trialsmentioning

confidence: 99%

Gene delivery nanoparticles to modulate angiogenesis

Kim

Mirando

Popel

et al. 2017

Advanced Drug Delivery Reviews

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Angiogenesis is naturally balanced by many pro- and anti-angiogenic factors while an imbalance of these factors leads to aberrant angiogenesis, which is closely associated with many diseases. Gene therapy has become a promising strategy for the treatment of such a disordered state through the introduction of exogenous nucleic acids that express or silence the target agents, thereby engineering neovascularization in both directions. Numerous non-viral gene delivery nanoparticles have been investigated towards this goal, but their clinical translation has been hampered by issues associated with safety, delivery efficiency, and therapeutic effect. This review summarizes key factors targeted for therapeutic angiogenesis and anti-angiogenesis gene therapy, non-viral nanoparticle-mediated approaches to gene delivery, and recent gene therapy applications in pre-clinical and clinical trials for ischemia, tissue regeneration, cancer, and wet age-related macular degeneration. Enhanced nanoparticle design strategies are also proposed to further improve the efficacy of gene delivery nanoparticles to modulate angiogenesis.

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Section: Clinical Trialsmentioning

confidence: 99%

Gene delivery nanoparticles to modulate angiogenesis

Kim

Mirando

Popel

et al. 2017

Advanced Drug Delivery Reviews

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“…The low effectiveness of cell therapy in clinical trials with patients with heart disease [ 145 , 146 ] may be attenuated by using these new findings in combination with gene therapy. A previous study from our group showed that the gene therapy provides continuous delivery of therapeutic proteins to the target site [ 147 ] and, at the same time, stem cells regulate the expression of growth factors by paracrine effect [ 66 , 144 ]. Ong et al [ 148 ] performed a combined delivery of CPC and plasmids carrying HIF-1 gene in mice after experimental AMI.…”

Section: Future Directionsmentioning

confidence: 99%

Cell Therapy in Ischemic Heart Disease: Interventions That Modulate Cardiac Regeneration

Schaun

Eibel

Kristocheck

et al. 2016

Stem Cells International

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The incidence of severe ischemic heart disease caused by coronary obstruction has progressively increased. Alternative forms of treatment have been studied in an attempt to regenerate myocardial tissue, induce angiogenesis, and improve clinical conditions. In this context, cell therapy has emerged as a promising alternative using cells with regenerative potential, focusing on the release of paracrine and autocrine factors that contribute to cell survival, angiogenesis, and tissue remodeling. Evidence of the safety, feasibility, and potential effectiveness of cell therapy has emerged from several clinical trials using different lineages of adult stem cells. The clinical benefit, however, is not yet well established. In this review, we discuss the therapeutic potential of cell therapy in terms of regenerative and angiogenic capacity after myocardial ischemia. In addition, we addressed nonpharmacological interventions that may influence this therapeutic practice, such as diet and physical training. This review brings together current data on pharmacological and nonpharmacological approaches to improve cell homing and cardiac repair.

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“…Thirteen patients with no-option refractory angina were treated with a plasmid carrying the VEGF 165 gene in a Brazilian phase I/II prospective clinical trial. The treatment was shown to be safe and improve clinical parameters in a follow-up one year later, with a transient increase in myocardial perfusion (Kalil et al , 2010; Giusti et al , 2013). In an independent study in Argentina, 10 patients with no-option coronary arterial disease were also treated with a plasmid carrying the gene for VEGF 165 in an open-label phase I trial with a two year follow-up.…”

Section: Gene Therapy In Latin Americamentioning

confidence: 99%

A snapshot of gene therapy in Latin America

Linden

Matte

2014

Genet. Mol. Biol.

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Gene therapy attempts the insertion and expression of exogenous genetic material in cells for therapeutic purposes. Conceived in the 1960s, gene therapy reached its first clinical trial at the end of the 1980s and by December 2013 around 600 genuine open clinical trials of gene therapy were registered at NIH Clinical Trials Database. Here, we summarize the current efforts towards the development of gene therapy in Latin America. Our survey shows that the number of scientists involved in the development of gene therapy and DNA vaccines in Latin America is still very low. Higher levels of investment in this technology are necessary to boost the advancement of innovation and intellectual property in this field in a way that would ease both the social and financial burden of various medical conditions in Latin America.

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High Doses of Vascular Endothelial Growth Factor 165 Safely, but Transiently, Improve Myocardial Perfusion in No-Option Ischemic Disease

Abstract: NCT00744315 http://clinicaltrials.gov/

Cited by 23 publications

References 19 publications

Gene delivery nanoparticles to modulate angiogenesis

Gene delivery nanoparticles to modulate angiogenesis

Cell Therapy in Ischemic Heart Disease: Interventions That Modulate Cardiac Regeneration

A snapshot of gene therapy in Latin America

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