Abstract
Injectable bone substitutes (IBSs) represent an attractive class of ready-to-use biomaterials, both ceramic- and polymer-based, as they offer the potential benefit of minimally invasive surgery and optimal defect filling. Although in vitro assessments are the first step in the process of development, the safety and efficacy of an IBS strongly depend on validated preclinical research prior to clinical trials. However, the selection of a suitable preclinical model for performance evaluation of an IBS remains a challenge, as no gold standard exists to define the best animal model. In order to succeed in this attempt, we identified three stages of development, including (a) proof-of-principle, (b) predictive validity and (c) general scientific legitimacy, and the respective criteria that should be applied for such selection. The second part of this review provides an overview of commonly used animals for IBSs. Specifically, scientific papers published between January 1996 and March 2012 were retrieved that report the use of preclinical models for the evaluation of IBSs in situations requiring bone healing and bone augmentation. This review is meant not only to describe the currently available preclinical models for IBS application, but also to address critical considerations of such multi-factorial evaluation models (including animal species, strain, age, anatomical site, defect size and type of bone), which can be indicative but in most cases edge away from the human reality. Consequently, the ultimate goal is to guide researchers toward a more careful and meaningful interpretation of the results of experiments using animal models and their clinical applications.
| Original language | English |
|---|---|
| Pages (from-to) | 191-209 |
| Number of pages | 19 |
| Journal | Journal of Tissue Engineering and Regenerative Medicine |
| Volume | 9 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 1 2015 |
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Keywords
- Animal models
- Bone augmentation
- Bone defect
- Bone substitutes
- Ceramic-based biomaterials
- Hydrogel-based biomaterials
- Injectable
- Preclinical studies
ASJC Scopus subject areas
- Biomedical Engineering
- Medicine (miscellaneous)
- Biomaterials
- Medicine(all)
Cite this
Preclinical evaluation of injectable bone substitute materials. / Bongio, Matilde; van den Beucken, Jeroen J J P; Leeuwenburgh, Sander C G; Jansen, John A.
In: Journal of Tissue Engineering and Regenerative Medicine, Vol. 9, No. 3, 01.03.2015, p. 191-209.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Preclinical evaluation of injectable bone substitute materials
AU - Bongio, Matilde
AU - van den Beucken, Jeroen J J P
AU - Leeuwenburgh, Sander C G
AU - Jansen, John A.
PY - 2015/3/1
Y1 - 2015/3/1
N2 - Injectable bone substitutes (IBSs) represent an attractive class of ready-to-use biomaterials, both ceramic- and polymer-based, as they offer the potential benefit of minimally invasive surgery and optimal defect filling. Although in vitro assessments are the first step in the process of development, the safety and efficacy of an IBS strongly depend on validated preclinical research prior to clinical trials. However, the selection of a suitable preclinical model for performance evaluation of an IBS remains a challenge, as no gold standard exists to define the best animal model. In order to succeed in this attempt, we identified three stages of development, including (a) proof-of-principle, (b) predictive validity and (c) general scientific legitimacy, and the respective criteria that should be applied for such selection. The second part of this review provides an overview of commonly used animals for IBSs. Specifically, scientific papers published between January 1996 and March 2012 were retrieved that report the use of preclinical models for the evaluation of IBSs in situations requiring bone healing and bone augmentation. This review is meant not only to describe the currently available preclinical models for IBS application, but also to address critical considerations of such multi-factorial evaluation models (including animal species, strain, age, anatomical site, defect size and type of bone), which can be indicative but in most cases edge away from the human reality. Consequently, the ultimate goal is to guide researchers toward a more careful and meaningful interpretation of the results of experiments using animal models and their clinical applications.
AB - Injectable bone substitutes (IBSs) represent an attractive class of ready-to-use biomaterials, both ceramic- and polymer-based, as they offer the potential benefit of minimally invasive surgery and optimal defect filling. Although in vitro assessments are the first step in the process of development, the safety and efficacy of an IBS strongly depend on validated preclinical research prior to clinical trials. However, the selection of a suitable preclinical model for performance evaluation of an IBS remains a challenge, as no gold standard exists to define the best animal model. In order to succeed in this attempt, we identified three stages of development, including (a) proof-of-principle, (b) predictive validity and (c) general scientific legitimacy, and the respective criteria that should be applied for such selection. The second part of this review provides an overview of commonly used animals for IBSs. Specifically, scientific papers published between January 1996 and March 2012 were retrieved that report the use of preclinical models for the evaluation of IBSs in situations requiring bone healing and bone augmentation. This review is meant not only to describe the currently available preclinical models for IBS application, but also to address critical considerations of such multi-factorial evaluation models (including animal species, strain, age, anatomical site, defect size and type of bone), which can be indicative but in most cases edge away from the human reality. Consequently, the ultimate goal is to guide researchers toward a more careful and meaningful interpretation of the results of experiments using animal models and their clinical applications.
KW - Animal models
KW - Bone augmentation
KW - Bone defect
KW - Bone substitutes
KW - Ceramic-based biomaterials
KW - Hydrogel-based biomaterials
KW - Injectable
KW - Preclinical studies
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UR - http://www.scopus.com/inward/citedby.url?scp=84925603861&partnerID=8YFLogxK
U2 - 10.1002/term.1637
DO - 10.1002/term.1637
M3 - Article
C2 - 23135814
AN - SCOPUS:84925603861
VL - 9
SP - 191
EP - 209
JO - Journal of Tissue Engineering and Regenerative Medicine
JF - Journal of Tissue Engineering and Regenerative Medicine
SN - 1932-6254
IS - 3
ER -