Evidence map›Paper›PMID 25251246›Full record

ArticlePloS one2014

Safety assessment of liver-targeted hydrodynamic gene delivery in dogs.

Kenya Kamimura, Tsutomu Kanefuji, Takeshi Yokoo, Hiroyuki Abe, Takeshi Suda, Yuji Kobayashi, Guisheng Zhang, Yutaka Aoyagi, Dexi Liu

Abstract read
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Kenya KamimuraDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Tsutomu KanefujiDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Takeshi YokooDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Hiroyuki AbeDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Takeshi SudaDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Yuji KobayashiDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Guisheng ZhangDepartment of Pharmaceutical and Biomedical Sciences, College of Pharmacy, University of Georgia, Athens, Georgia, United States of America.
Yutaka AoyagiDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Dexi LiuDepartment of Pharmaceutical and Biomedical Sciences, College of Pharmacy, University of Georgia, Athens, Georgia, United States of America.

Funding

New Polymeric Carriers for Pulmonary Gene DeliveryR01HL075542 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI LIU, DEXI · 2004 to 2007
$1.3M
Bifunctional Compounds for Targeted Gene DeliveryR01EB002946 · NIBIB · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI LIU, DEXI · 2003 to 2006
$1.1M
NHLBI NIH HHS HL075542NHLBI NIH HHS R01 HL075542NIBIB NIH HHS EB002946NIBIB NIH HHS R01 EB002946
6 · The paper itself

Abstract

Evidence in support of safety of a gene delivery procedure is essential toward gene therapy. Previous studies using the hydrodynamics-based procedure primarily focus on gene delivery efficiency or gene function analysis in mice. The current study focuses on an assessment of the safety of computer-controlled and liver-targeted hydrodynamic gene delivery in dogs as the first step toward hydrodynamic gene therapy in clinic. We demonstrate that the impacts of the hydrodynamic procedure were limited in the injected region and the influences were transient. Histological examination and the hepatic microcirculation measurement using reflectance spectrophotometry reveal that the liver-specific impact of the procedure involves a transient expansion of the liver sinusoids. No systemic damage or toxicity was observed. Physiological parameters, including electrocardiogram, heart rate, blood pressure, oxygen saturation, and body temperature, remained in normal ranges during and after hydrodynamic injection. Body weight was also examined to assess the long-term effects of the procedure in animals who underwent 3 hydrodynamic injections in 6 weeks with 2-week time interval in between. Serum biochemistry analysis showed a transient increase in liver enzymes and a few cytokines upon injection. These results demonstrate that image-guided, liver-specific hydrodynamic gene delivery is safe.

Indexed as

Gene Transfer TechniquesHydrodynamicsAnimalsChemokine CCL2DogsElectrocardiographyGenetic TherapyInjectionsInterleukin-10Interleukin-6LiverLiver CirculationMonitoring, PhysiologicReproducibility of ResultsRisk AssessmentTumor Necrosis Factor-alphaChemokine CCL2Interleukin-10Interleukin-6Tumor Necrosis Factor-alpha

Identifiers

PMID25251246
PMCPMC4175463

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.