scholarly journals In Vivo Anti-Typhoid and Safety Evaluation of Extracts of Ximenia americana on Experimental Rats

2021 ◽  
pp. 100009
Author(s):  
Hadiza Lami Muhammad ◽  
Rahinat Garba ◽  
Abubakar Siddique Abdullah ◽  
Hadiza Kudu Muhammad ◽  
Musa Bola Busari ◽  
...  
Keyword(s):  
Safety Evaluation ◽  
Ximenia Americana

scholarly journals Genome-wide integration site detection using Cas9 enriched amplification-free long-range sequencing

2020 ◽  
Author(s):  
Joost van Haasteren ◽  
Altar M Munis ◽  
Deborah R Gill ◽  
Stephen C Hyde
Keyword(s):  
Long Range ◽  
Insertional Mutagenesis ◽  
Lentiviral Vector ◽  
Integration Site ◽  
Low Cost ◽  
Safety Evaluation ◽  
Read Length ◽  
Chromosomal Dna ◽  
Wide Range

Abstract The gene and cell therapy fields are advancing rapidly, with a potential to treat and cure a wide range of diseases, and lentivirus-based gene transfer agents are the vector of choice for many investigators. Early cases of insertional mutagenesis caused by gammaretroviral vectors highlighted that integration site (IS) analysis was a major safety and quality control checkpoint for lentiviral applications. The methods established to detect lentiviral integrations using next-generation sequencing (NGS) are limited by short read length, inadvertent PCR bias, low yield, or lengthy protocols. Here, we describe a new method to sequence IS using Amplification-free Integration Site sequencing (AFIS-Seq). AFIS-Seq is based on amplification-free, Cas9-mediated enrichment of high-molecular-weight chromosomal DNA suitable for long-range Nanopore MinION sequencing. This accessible and low-cost approach generates long reads enabling IS mapping with high certainty within a single day. We demonstrate proof-of-concept by mapping IS of lentiviral vectors in a variety of cell models and report up to 1600-fold enrichment of the signal. This method can be further extended to sequencing of Cas9-mediated integration of genes and to in vivo analysis of IS. AFIS-Seq uses long-read sequencing to facilitate safety evaluation of preclinical lentiviral vector gene therapies by providing IS analysis with improved confidence.

Anticancer activity in vitro and biological safety evaluation in vivo of Sika deer antler protein

2017 ◽  
Vol 41 (6) ◽  
pp. e12421 ◽  
Author(s):  
Huihai Yang ◽  
Lulu Wang ◽  
Hang Sun ◽  
Xiaofeng He ◽  
Jing Zhang ◽  
...  
Keyword(s):  
Anticancer Activity ◽  
Sika Deer ◽  
Safety Evaluation ◽  
Deer Antler ◽  
Biological Safety

scholarly journals Biocellulose Masks as Delivery Systems: A Novel Methodological Approach to Assure Quality and Safety

Cosmetics ◽  
2018 ◽  
Vol 5 (4) ◽  
pp. 66 ◽  
Author(s):  
Paola Perugini ◽  
Mariella Bleve ◽  
Fabiola Cortinovis ◽  
Antonio Colpani
Keyword(s):  
Light Scattering ◽  
Bacterial Cellulose ◽  
Near Infrared ◽  
Gas Permeability ◽  
Methodological Approach ◽  
Safety Evaluation ◽  
Nir Spectroscopy ◽  
Quality And Safety ◽  
Multiple Light Scattering

Bacterial cellulose (BC) has become of great interest in recent years, as a delivery system in several areas of application, including food, drugs, and cosmetics, thanks to its exclusive advantages, such as high biocompatibility, water holding capacity, and good gas permeability. The novel approach of the authors has led to a protocol for checking the quality and safety of bacterial cellulose matrices in the manufacture of cosmetic masks. Two non-destructive techniques, near-infrared spectroscopy (NIR) and multiple light scattering (MLS), were used to verify different parameters affecting the quality of BC sheets, allowing cellulose masks to be checked over time. NIR spectroscopy allowed for discovering changes in the water content, depending on filling/packaging procedures, like flat-folding. Multiple light scattering was used to ascertain the stability of solutions in contact with masks. From a clinical standpoint, the cutaneous tolerability of biocellulose masks, and their effect on skin parameters, were evaluated through some specific “in vivo” tests. Also, a safety evaluation during application was conducted through different studies: a short-term one after single application, and a long-term one upon continued use.

Evaluation of low molecular weight polyethylenimine-introduced chitosan for gene delivery to mesenchymal stem cells

2020 ◽  
Vol 10 (7) ◽  
pp. 1170-1176
Author(s):  
Minchen Liu ◽  
Yulan Hu ◽  
Yi Feng
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Gene Delivery ◽  
Transfection Efficiency ◽  
A549 Cells ◽  
Safety Evaluation ◽  
Physicochemical Characteristics ◽  
Hatching Rate

This study aimed to examine the transfection ability of polyethylenimine (PEI) (1800 Da)-grafted chitosan (10 kDa) (CP), a newly synthesized PEI derivative, in mesenchymal stem cells (MSCs). The safety evaluation of the complex/DNA was studied in vitro and in vivo. In addition, CP/pGL3 was applied to investigate the effects of transfection efficiency. In this study, CP/DNA can be formed with compatible physicochemical characteristics for gene delivery. CP cytotoxicity decreased in A549 cells. Moreover, a zebrafish embryo model was used for evaluating the safety in vivo. Compared to the PEI (25 kDa) group, the zebrafish hatching rate increased and the mortality rate decreased in the CP/DNA group, which provided an indication of the safety of CP. In comparison with chitosan (100 kDa)-PEI (1200 Da), CP's transfection efficiency was higher in both A549 cells and MSCs. This study aimed to lay the foundation for further applications of CP in gene delivery. Therefore, further gene therapy investigations of CP by using MSCs need to be performed.

scholarly journals In vivo Efficacy and Safety Evaluation of Lactosyl-β-cyclodextrin as a Therapeutic Agent for Hepatomegaly in Niemann-Pick Type C Disease

Nanomaterials ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. 802 ◽  
Author(s):  
Yuki Maeda ◽  
Keiichi Motoyama ◽  
Rena Nishiyama ◽  
Taishi Higashi ◽  
Risako Onodera ◽  
...  
Keyword(s):  
Free Cholesterol ◽  
Subcutaneous Administration ◽  
Safety Evaluation ◽  
Autosomal Recessive Disorder ◽  
Liver Cells ◽  
High Dose ◽  
Efficacy And Safety ◽  
Type C ◽  
Niemann Pick

Niemann-Pick type C disease (NPC) is a fatal, autosomal recessive disorder, which causes excessive accumulation of free cholesterol in endolysosomes, resulting in progressive hepatomegaly and neurodegeneration. Currently, 2-hydroxypropyl-β-cyclodextrin (HP-β-CyD) is used at a high dose for the treatment of NPC, risking lung toxicity and hearing loss during treatment. One method to reduce the required dose of HP-β-CyD for the treatment of hepatomegaly is to actively deliver β-cyclodextrin (β-CyD) to hepatocytes. Previously, we synthesized lactosyl-β-CyD (Lac-β-CyD) and demonstrated that it lowers cholesterol in NPC model liver cells. In the present study, we studied the efficacy and safety of Lac-β-CyD treatment of hepatomegaly in Npc1−/− mice. After subcutaneous administration, Lac-β-CyD accumulated in the liver and reduced hepatomegaly with greater efficacy than HP-β-CyD. In addition, subcutaneous administration of a very high dose of Lac-β-CyD was less toxic to the lungs than HP-β-CyD. Notably, the accumulation of intracellular free cholesterol in endolysosomes of NPC-like liver cells was significantly lower after administration of Lac-β-CyD than after treatment with HP-β-CyD. In conclusion, these results suggest that Lac-β-CyD is a candidate for the effective treatment of hepatomegaly in NPC.

In vivo biological safety evaluation of an iron-based bioresorbable drug-eluting stent

BioMetals ◽  
2020 ◽  
Vol 33 (4-5) ◽  
pp. 217-228
Author(s):  
Jianfeng Shi ◽  
Xuewen Miao ◽  
Haiyang Fu ◽  
Aili Jiang ◽  
YanFen Liu ◽  
...  
Keyword(s):  
Safety Evaluation ◽  
Drug Eluting Stent ◽  
Biological Safety ◽  
Drug Eluting ◽  
Iron Based

scholarly journals Antibacterial and Toxicity Evaluation of Eastern Medicine Formulation Eczegone for the Management of Eczema

Dose-Response ◽  
2020 ◽  
Vol 18 (3) ◽  
pp. 155932582095679
Author(s):  
Muhammad Amjad Chishti ◽  
Ejaz Mohi-Ud-Din ◽  
Shahbaz Ahmad Zakki ◽  
Muhammad Rahil Aslam ◽  
Sheraz Siddiqui ◽  
...  
Keyword(s):  
Antibacterial Activity ◽  
Safety Evaluation ◽  
Diffusion Method ◽  
In Vitro Toxicity ◽  
Klebsiella Pneumonia ◽  
Lawsonia Inermis ◽  
Disk Diffusion Method ◽  
Skin Keratinocytes

The present study was conducted to evaluate the antibacterial activity, in vitro and in vivo cytotoxicity, cell viability and safety of Eastern Medicine coded medicinal formulation Eczegone comprising extracts of Azadirachta indica (Azin) , Fumaria indica (Fuin) , Sphaeranthus indicus (Spin) and Lawsonia inermis (Lain). This work also evaluated antibacterial activity of Eczegone formulation having above mentioned plants ethanolic extracts against different bacteria’s by disk diffusion method. In vitro toxicity of Eczegone formulation was investigated by using human skin keratinocytes HaCaT cell line, crystal violet stained cells, and methyl tetrazolium cytotoxicity (MTT) assay. In vivo acute oral and dermal cytotoxicity was determined by using Swiss albino mice and albino rabbits, respectively. The Eczegone formulation showed antibacterial activity against 3 gram negative bacteria including Escherichia coli, Klebsiella pneumonia, Proteus vulgaris and a gram positive Staphylococcus aureus. We didn’t observe any toxic effect of Eczegone formulation on the skin keratinocytes. Furthermore, the Ezcegone formulation was non-irritant according to draize score (OECD TG404, 2002). After rigorous safety evaluation by in vitro and in vivo acute oral and dermal toxicity analysis, we concluded that Eczegone formualtion possessses antibacterial effects and is safe, non-toxic, non-irritant, and the drug would be subjected for further biochemical and clinical studies.

scholarly journals Chitosan-Based Thermo-Sensitive Hydrogel Loading Oyster Peptides for Hemostasis Application

Materials ◽  
2020 ◽  
Vol 13 (21) ◽  
pp. 5038
Author(s):  
Dongying Zhang ◽  
Zhang Hu ◽  
Lingyu Zhang ◽  
Sitong Lu ◽  
Fengyan Liang ◽  
...  
Keyword(s):  
Matrix Material ◽  
Safety Evaluation ◽  
Massive Hemorrhage ◽  
Gelatin Sponge ◽  
Glycerol Phosphate ◽  
Modified Chitosan ◽  
The Matrix ◽  
Adsorption Rates

Uncontrolled massive hemorrhage is one of the principal causes of death in trauma emergencies. By using catechol-modified chitosan (CS-C) as the matrix material and β glycerol phosphate (β-GP) as a thermo-sensitive agent, chitosan-based thermo-sensitive hydrogel loading oyster peptides (CS-C/OP/β-GP) were prepared at physiological temperature. The hemostatic performance of CS-C/OP/β-GP hydrogel was tested in vivo and in vitro, and its biological safety was evaluated. The results showed that the in vitro coagulation time and blood coagulation index of CS-C/OP/β-GP hydrogel were better than those of a commercial gelatin sponge. Notably, compared with the gelatin sponge, CS-C/OP/β-GP hydrogel showed that the platelet adhesion and erythrocyte adsorption rates were 38.98% and 95.87% higher, respectively. Additionally, the hemostasis time in mouse liver injury was shortened by 19.5%, and the mass of blood loss in the mouse tail amputation model was reduced by 18.9%. The safety evaluation results demonstrated that CS-C/OP/β-GP had no cytotoxicity to L929 cells, and the hemolysis rates were less than 5% within 1 mg/mL, suggesting good biocompatibility. In conclusion, our results indicate that CS-C/OP/β-GP is expected to be a promising dressing in the field of medical hemostasis.

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