Literature DB >> 21103738

VEGF gene therapy for angiogenesis in refractory angina: phase I/II clinical trial.

Renato A K Kalil1, Felipe Borsu de Salles, Imarilde Inês Giusti, Clarissa Garcia Rodrigues, Sang Won Han, Roberto Tofani Sant'Anna, Eduardo Ludwig, Gabriel Grossman, Paulo Roberto Lunardi Prates, João Ricardo Michelin Sant'anna, Guaracy Fernandes Teixeira Filho, Nance Beyer Nardi, Ivo Abrahão Nesralla.   

Abstract

OBJECTIVE: Safety, feasibility and early myocardial angiogenic effects evaluation of transthoracic intramyocardial phVEGF165 administration for refractory angina in no option patients.
METHODS: Cohort study, in which 13 patients with refractory angina under optimized clinical treatment where included, after cineangiograms had been evaluated and found unfeasible by surgeon and interventional cardiologist. Intramyocardial injections of 5 mL solution containing plasmidial VEGF165 where done over the ischemic area of myocardium identified by previous SPECT/Sestamibi scan. Evaluations included a SPECT scan, stress test, Minnesota QOL questionnaire and NYHA functional class and CCS angina class determinations.
RESULTS: There were no deaths or new interventions during the study period. There were no significant variations in SPECT scans, QOL scores and stress tests results during medical treatment in the included patients. After the 3rd post operative month, there was improvement in SPECT segmental scores, SSS (18.38 ± 7.51 vs. 15.31 ± 7.29, P = 0.003) and SRS (11.92 ± 7.49 vs. 8.53 ± 6.68, P = 0.002). The ischemic area extension, however, had non-significant variation (23.38 ± 13.12% vs. 20.08 ± 13.88%, P = 0.1). Stress tests METs varied from 7.66 ± 4.47 pre to 10.29 ± 4.36 METs post-op (P = 0.08). QOL score improved from 48.23 ± 18.35 pre to 30.15 ± 20.13 post-op points (P = 0.02). NYHA class was 3.15 ± 0.38 pre vs. 1.77 ± 0.83 post-op (P = 0.001) and angina CCS class, 3.08 ± 0.64 vs. 1.77 ± 0.83 (P = 0.001).
CONCLUSIONS: Intramyocardial VEGF165 therapy for refractory angina, in this small trial of no option patients, resulted feasible and safe. Early clinical and scintilographic data showed improvements in symptoms and myocardial perfusion, with regression of ischemia severity in treated areas.

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Year:  2010        PMID: 21103738     DOI: 10.1590/s0102-76382010000300006

Source DB:  PubMed          Journal:  Rev Bras Cir Cardiovasc


  10 in total

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6.  VEGF 165 gene therapy for patients with refractory angina: mobilization of endothelial progenitor cells.

Authors:  Clarissa G Rodrigues; Rodrigo D M Plentz; Thiago Dipp; Felipe B Salles; Imarilde I Giusti; Roberto T Sant'Anna; Bruna Eibel; Ivo A Nesralla; Melissa Markoski; Nance N Beyer; Renato A K Kalil
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  10 in total

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