Identification and analysis of an impurity inducing clinical adverse effect in anti-adhesion carboxymethyl chitosan products

Yu, Mingming; Jiang, Tianyue; Dongyan, Wang; Lv, Zhi-Hua

doi:10.1016/j.jpba.2013.06.023

Cited by 8 publications

(2 citation statements)

References 38 publications

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“…Chloroacetic acid residue, as one of the typical synthetic by-products, has attracted considerable concerns for its biological safety. 24 Several researchers have found that chloroacetic acid could decrease the cell viability of different cell lines. Diethylene glycol has been implicated in multiple medication-associated mass poisonings, which can result in renal and neurological toxicity.…”

Section: Resultsmentioning

confidence: 99%

Hemostatic effect and safety evaluation of the absorbable macroporous polysaccharides composite hemostatic material prepared by a green fabrication approach

Ren

Gong

et al. 2022

J Biomater Appl

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Carboxymethyl chitosan is widely used in the medical field such as wound healing and other medical fields. We previously fabricated the absorbable macroporous polysaccharides composite hemostatics (AMPCs) mainly composed of carboxymethyl chitosan which possess excellent hemostatic effect. To further elucidate the impact of CMCTs on the hemostatic effect and biosafety of AMPCs, carboxymethyl chitosan with different properties were used to prepare AMPCs. By comparing the physical and chemical properties, AMPCs performed high water absorption ability, especially Group 1 (swelling ratio reached 5792%), which facilitated the rapid formation of blood clots. It was confirmed by blood clotting index (BCI) and blood coagulation tests in vitro that Group 1 showed a slightly higher coagulation capacity than groups 2 and 3, which may be due to the positive charge on the surface of the cations in the salts attaches to the negative charge on the surface of the red blood cells, an electrostatic neutralization reaction occurs. The biosafety was a preliminary evaluation by implanted AMPCs into the back of Sprague-Dawley rats and the tissue was harvested after feeding for 28 days. The AMPCs exhibited good biosafety for whole blood and major organs during the degradation in vivo: during the degradation of AMPCs, excluding changes in some serum indicators, no tissue necrosis or inflammatory cell infiltration was observed in these organs, either by gross observation or histological analysis. These findings demonstrate that expecting to develop a highly functional and safe hemostatic agent based on Group 1 for rapid hemostasis applications in emergencies.

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Section: Resultsmentioning

confidence: 99%

Hemostatic effect and safety evaluation of the absorbable macroporous polysaccharides composite hemostatic material prepared by a green fabrication approach

Ren

Gong

et al. 2022

J Biomater Appl

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“…Difficulties in terms of developing safe and effective chitosan-based biomaterials could reside in the lack of in-depth exploration of its biocompatibility, its biodegradability, and the resulting biological response to the biomaterial in host tissues [11]. The immunoreactivity of chitosan, as well as the effect of chitosan impurities, such as bacterial endotoxins [12] or process residues [13], on the biological reactivity of commercially-available chitosan is also evidenced as a limitation in the literature.…”

Section: Introductionmentioning

confidence: 99%

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

Douette¹,

Chausson²,

Théâtre³

et al. 2020

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When designing innovative biomaterials, biocompatibility is regarded as a prerequisite for safe clinical use in humans. In this study, the biological safety of KiOmedine® CM-chitosan, which is a non-animal carboxymethyl chitosan biomaterial, was evaluated using a large panel of both in vitro and in vivo biocompatibility tests in accordance with the ISO 10993 series. KiOmedine® CM-chitosan was non-cytotoxic and non-genotoxic in vitro. The biomaterial was neither found to be haemolytic nor was it able to potentiate the activation of the central complement component C5a or the inflammatory mediators IL-1β and IL-8 in the presence of human whole blood. Furthermore, no evidence of any significant irritation, sensitization, pyrogenicity, and organ toxicity was detected in specific animal studies conducted with KiOmedine® CM-chitosan, and only minimal local tissue effects were observed after the intra-articular or intra-dermal injection of KiOmedine® CM-chitosan in the rabbit model. KiOmedine® CM-chitosan had minimal potential to induce immunotoxic reactions in the mouse air pouch model. Its biodegradation process was appropriately characterized at the histological level. In summary, our study represents an unprecedented body of work supporting the biological safety evaluation of KiOmedine® CM-chitosan, allowing its use in injectable medical devices.

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Multilayer coating of a 3D-printed tracheal stent prevents tracheal stenosis

Zhang,

Zhuang,

Zhang

et al. 2024

Applied Materials Today

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Identification and analysis of an impurity inducing clinical adverse effect in anti-adhesion carboxymethyl chitosan products

Cited by 8 publications

References 38 publications

Hemostatic effect and safety evaluation of the absorbable macroporous polysaccharides composite hemostatic material prepared by a green fabrication approach

Hemostatic effect and safety evaluation of the absorbable macroporous polysaccharides composite hemostatic material prepared by a green fabrication approach

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

Multilayer coating of a 3D-printed tracheal stent prevents tracheal stenosis

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