scholarly journals Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications

2020 ◽  
Vol 4 (2) ◽  
pp. 39
Author(s):  
Pierre Douette ◽  
Mickael Chausson ◽  
Emilie Theatre ◽  
Catherine Philippart ◽  
Sandrine Gautier ◽  
...  
Materials ◽  
2021 ◽  
Vol 14 (4) ◽  
pp. 731
Author(s):  
Yoshimitsu Okazaki ◽  
Shin-ichi Katsuda

We performed biological safety evaluation tests of three Ti–Zr alloys under accelerated extraction condition. We also conducted histopathological analysis of long-term implantation of pure V, Al, Ni, Zr, Nb, and Ta metals as well as Ni–Ti and high-V-containing Ti–15V–3Al–3Sn alloys in rats. The effect of the dental implant (screw) shape on morphometrical parameters was investigated using rabbits. Moreover, we examined the maximum pullout properties of grit-blasted Ti–Zr alloys after their implantation in rabbits. The biological safety evaluation tests of three Ti–Zr alloys (Ti–15Zr–4Nb, Ti–15Zr–4Nb–1Ta, and Ti–15Zr–4Nb–4Ta) showed no adverse (negative) effects of either normal or accelerated extraction. No bone was formed around the pure V and Ni implants. The Al, Zr, Nb, and Ni–Ti implants were surrounded by new bone. The new bone formed around Ti–Ni and high-V-containing Ti alloys tended to be thinner than that formed around Ti–Zr and Ti–6Al–4V alloys. The rate of bone formation on the threaded portion in the Ti–15Zr–4Nb–4Ta dental implant was the same as that on a smooth surface. The maximum pullout loads of the grit- and shot-blasted Ti–Zr alloys increased linearly with implantation period in rabbits. The pullout load of grit-blasted Ti–Zr alloy rods was higher than that of shot-blasted ones. The surface roughness (Ra) and area ratio of residual Al2O3 particles of the Ti–15Zr–4Nb alloy surface grit-blasted with Al2O3 particles were the same as those of the grit-blasted Alloclassic stem surface. It was clarified that the grit-blasted Ti–15Zr–4Nb alloy could be used for artificial hip joint stems.


2017 ◽  
Vol 41 (6) ◽  
pp. e12421 ◽  
Author(s):  
Huihai Yang ◽  
Lulu Wang ◽  
Hang Sun ◽  
Xiaofeng He ◽  
Jing Zhang ◽  
...  

2017 ◽  
Vol 2 (1) ◽  
pp. 1
Author(s):  
Maula Eka Sriyani ◽  
Hendris Wongso ◽  
Eva Maria Widyasari ◽  
Rizky Juwita Sugiharti ◽  
Iim Halimah ◽  
...  

Infectious diseases have become one of the leading cause of mortality around the world, including in the Southeast Asia. One of the microbial that cause infection is fungi. Occasionally, deep-seated fungal infection is difficult to detect using conventional diagnosis methods and therefore leads to inaccurate detection. Our previous research was conducted in order to obtain the labeled compound of <sup>99m</sup>Tc-DTPA-Ketoconazole with a high radiochemical purity (98.40 ± 0.86%). Moreover, the in-vitro assays showed that <sup>99m</sup>Tc-DTPA-Ketoconazole can potentially bind to Candida albicans. On the other hand, in clinical routine use, diagnostic kit should be safe for the patients. Consequently, this research was conducted to determine the biological safety parameters of <sup>99m</sup>Tc-DTPA-Ketoconazole on the animal study, including single dose and acute toxicity test, sterility, and apirogenicity test. The results showed that both the single dose at 34.6 μCi and dose until 149 times of the single dose did not stimulate the toxic response to the animals. In addition, the sterility data revealed that there was no microbial growth after 7 days of incubation at 37°C as well as fungal growth after 14 days of incubation at 25°C. Furthermore, the apirogenicity test using rabbits revealed that there was no increase in temperature more than 0.6°C for each animal and not more than 1.5°C of total increase of temperature for all the animals. It is concluded that the <sup>99m</sup>Tc-DTPA-Ketoconazole is satisfy the requirements of biological safety of a radiopharmaceutical and therefore was acceptable for fungal detection in nuclear medicine.


BioMetals ◽  
2020 ◽  
Vol 33 (4-5) ◽  
pp. 217-228
Author(s):  
Jianfeng Shi ◽  
Xuewen Miao ◽  
Haiyang Fu ◽  
Aili Jiang ◽  
YanFen Liu ◽  
...  

Molecules ◽  
2020 ◽  
Vol 25 (13) ◽  
pp. 3050
Author(s):  
Yujie Chen ◽  
Runjing Zhang ◽  
Baiqin Zheng ◽  
Chao Cai ◽  
Zhen Chen ◽  
...  

Injectable hydrogels have attracted growing interests as promising biomaterials for clinical applications, due to their minimum invasive implanting approach and easy-handling performance. Nevertheless, natural biomaterials-based injectable hydrogels with desirable nontoxicity are suffering from limited functions, failing to fulfill the requirements of clinical biomaterials. The development of novel injectable biomaterials with a combination of biocompatibility and adequate functional properties is a growing urgency toward biomedical applications. In this contribution, we report a simple and effective approach to fabricate multi-functional CMC-OSA-DTP hydrogels. Two kinds of natural polysaccharide derived polymers, carboxymethyl chitosan (CMC) and oxidized alginate (OSA) along with 3,3′-dithiopropionic acid dihydrazide (DTP) were utilized to introduce three dynamic covalent bonds. Owing to the existence of triple dynamic bonds, this unique CMC-OSA-DTP hydrogel possessed smart redox and pH stimuli-responsive property, injectability as well as self-healing ability. In addition, the CCK-8 and live/dead assays demonstrated satisfying cytocompatibility of the CMC-OSA-DTP hydrogel in vitro. Based on its attractive properties, this easy-fabricated and multi-functional hydrogel demonstrated the great potential as an injectable biomaterial in a variety of biomedical applications.


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