Evaluation of Preclinical Models for the Testing of Bone Tissue-Engineered Constructs

Area of Science:

• Biomaterials Science
• Regenerative Medicine
• Orthopedic Surgery

Background:

• Autologous bone grafting is the gold standard for bone defects but has limitations.
• Tissue engineering (TE) offers a promising alternative, yet clinical translation remains a challenge.
• Lack of reproducibility in preclinical studies may impede the advancement of TE therapies.

Purpose of the Study:

• To evaluate preclinical models used for testing bone tissue engineering (BTE) strategies.
• To assess researchers' and clinicians' perceptions of current BTE preclinical models.
• To identify barriers to the clinical translation of BTE research.

Main Methods:

• A literature review of 169 in vivo BTE studies from the past 10 years.
• A survey of 70 clinicians and scientists regarding clinical needs and model satisfaction.
• Analysis of animal models, defect types, and fixation techniques in published studies.

Main Results:

• Most studies used small animal models (rats, rabbits), with few using skeletally mature animals.
• A significant clinical need for TE constructs was confirmed, with positive perceptions of future applications.
• Researchers and clinicians highlighted the need for optimized, standardized preclinical models and improved translational aspects.

Conclusions:

• Current preclinical models for bone tissue engineering are not adequately standardized or clinically relevant.
• There is a critical need to refine and standardize preclinical models to improve the translation of TE strategies to clinical practice.
• Achieving consensus on a limited set of well-standardized models is essential for advancing bone TE.