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

Pierre Douette; Mickael Chausson; Emilie Theatre; Catherine Philippart; Sandrine Gautier; Jacques Bentin; Laurence Hermitte

doi:doi:10.11648/j.jb.20200402.12

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

Pierre Douette, Mickael Chausson, Emilie Theatre, Catherine Philippart, Sandrine Gautier, Jacques Bentin, Laurence Hermitte

Published in Journal of Biomaterials (Volume 4, Issue 2)

Received: 7 September 2020 Accepted: 19 September 2020 Published: 25 September 2020

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Abstract

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.

Published in	Journal of Biomaterials (Volume 4, Issue 2)
DOI	10.11648/j.jb.20200402.12
Page(s)	39-50
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2020. Published by Science Publishing Group

Keywords

Carboxymethyl Chitosan Biomaterial, Biocompatibility, Toxicology

References

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APA Style

Pierre Douette, Mickael Chausson, Emilie Theatre, Catherine Philippart, Sandrine Gautier, et al. (2020). Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications. Journal of Biomaterials, 4(2), 39-50. https://doi.org/10.11648/j.jb.20200402.12

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ACS Style

Pierre Douette; Mickael Chausson; Emilie Theatre; Catherine Philippart; Sandrine Gautier, et al. Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications. J. Biomater. 2020, 4(2), 39-50. doi: 10.11648/j.jb.20200402.12

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AMA Style

Pierre Douette, Mickael Chausson, Emilie Theatre, Catherine Philippart, Sandrine Gautier, et al. Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications. J Biomater. 2020;4(2):39-50. doi: 10.11648/j.jb.20200402.12

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@article{10.11648/j.jb.20200402.12,
  author = {Pierre Douette and Mickael Chausson and Emilie Theatre and Catherine Philippart and Sandrine Gautier and Jacques Bentin and Laurence Hermitte},
  title = {Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications},
  journal = {Journal of Biomaterials},
  volume = {4},
  number = {2},
  pages = {39-50},
  doi = {10.11648/j.jb.20200402.12},
  url = {https://doi.org/10.11648/j.jb.20200402.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.jb.20200402.12},
  abstract = {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.},
 year = {2020}
}

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TY  - JOUR
T1  - Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications
AU  - Pierre Douette
AU  - Mickael Chausson
AU  - Emilie Theatre
AU  - Catherine Philippart
AU  - Sandrine Gautier
AU  - Jacques Bentin
AU  - Laurence Hermitte
Y1  - 2020/09/25
PY  - 2020
N1  - https://doi.org/10.11648/j.jb.20200402.12
DO  - 10.11648/j.jb.20200402.12
T2  - Journal of Biomaterials
JF  - Journal of Biomaterials
JO  - Journal of Biomaterials
SP  - 39
EP  - 50
PB  - Science Publishing Group
SN  - 2640-2629
UR  - https://doi.org/10.11648/j.jb.20200402.12
AB  - 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.
VL  - 4
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Author Information

Pierre Douette

Kiomed Pharma, Herstal, Belgium
Mickael Chausson

Kiomed Pharma, Herstal, Belgium
Emilie Theatre

Kiomed Pharma, Herstal, Belgium
Catherine Philippart

Kiomed Pharma, Herstal, Belgium
Sandrine Gautier

Kiomed Pharma, Herstal, Belgium
Jacques Bentin

Department of rheumatology, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium
Laurence Hermitte

Kiomed Pharma, Herstal, Belgium

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APA Style

Pierre Douette, Mickael Chausson, Emilie Theatre, Catherine Philippart, Sandrine Gautier, et al. (2020). Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications. Journal of Biomaterials, 4(2), 39-50. https://doi.org/10.11648/j.jb.20200402.12

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ACS Style

Pierre Douette; Mickael Chausson; Emilie Theatre; Catherine Philippart; Sandrine Gautier, et al. Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications. J. Biomater. 2020, 4(2), 39-50. doi: 10.11648/j.jb.20200402.12

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AMA Style

Pierre Douette, Mickael Chausson, Emilie Theatre, Catherine Philippart, Sandrine Gautier, et al. Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications. J Biomater. 2020;4(2):39-50. doi: 10.11648/j.jb.20200402.12

Copy | Download

@article{10.11648/j.jb.20200402.12,
  author = {Pierre Douette and Mickael Chausson and Emilie Theatre and Catherine Philippart and Sandrine Gautier and Jacques Bentin and Laurence Hermitte},
  title = {Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications},
  journal = {Journal of Biomaterials},
  volume = {4},
  number = {2},
  pages = {39-50},
  doi = {10.11648/j.jb.20200402.12},
  url = {https://doi.org/10.11648/j.jb.20200402.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.jb.20200402.12},
  abstract = {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.},
 year = {2020}
}

Copy | Download

TY  - JOUR
T1  - Biological Safety Evaluation of KiOmedine® CM-chitosan, an Innovative Non-animal Carboxymethyl-Chitosan Biomaterial Intended for Injectable Biomedical Applications
AU  - Pierre Douette
AU  - Mickael Chausson
AU  - Emilie Theatre
AU  - Catherine Philippart
AU  - Sandrine Gautier
AU  - Jacques Bentin
AU  - Laurence Hermitte
Y1  - 2020/09/25
PY  - 2020
N1  - https://doi.org/10.11648/j.jb.20200402.12
DO  - 10.11648/j.jb.20200402.12
T2  - Journal of Biomaterials
JF  - Journal of Biomaterials
JO  - Journal of Biomaterials
SP  - 39
EP  - 50
PB  - Science Publishing Group
SN  - 2640-2629
UR  - https://doi.org/10.11648/j.jb.20200402.12
AB  - 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.
VL  - 4
IS  - 2
ER  -

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