Personalized and genetically engineered animal models for next-generation surgical implant validation

Area of Science:

• Biomedical Engineering
• Regenerative Medicine
• Translational Science

Background:

• Personalized and genetically engineered animal models (GEAMs) offer improved physiological and predictive relevance for preclinical validation of surgical devices.
• Advancements in CRISPR/Cas9 and transgenic techniques enable precise genetic modifications for enhanced disease modeling and biomimicry.

Purpose of the Study:

• To review qualitative and quantitative evaluations of implant performance in bespoke animal models across various tissue types (bone, cardiovascular, neural, soft tissue).
• To highlight the potential of combining bioengineered implants with disease-specific animal models for improved clinical outcomes.

Main Methods:

• Utilizing genetically engineered animal models, including biomechanically Engineered Genetic Model (EGM) scaffolds, humanized immune models, and disease-specific models (e.g., osteoporotic, diabetic).
• Employing techniques such as CRISPR/Cas9 for genetic modifications in donor induced pluripotent stem cells (PSCs).
• Evaluating implant performance through metrics like bone development, endothelialization rates, thrombosis risk, implant integration, rejection, and wound healing.

Main Results:

• EGM scaffolds in osteoporotic rat models demonstrated a significant decrease in RUNX2 expression.
• Humanized porcine models for cardiac implants showed increased endothelialization and reduced thrombosis risk.
• Immune-humanized mouse models indicated improved implant integration, longevity, and reduced inflammatory responses; smart implants in diabetic models accelerated wound healing by 60%.

Conclusions:

• Genetically engineered animal models and bioengineered implants represent a significant advancement in preclinical validation, offering personalized and predictive insights.
• Addressing challenges like genetic drift, ethical considerations, and translational gaps is crucial for realizing the full potential of personalized implant technology.
• Future research should focus on regulatory considerations and developing blueprints to align personalized implant technology with clinical effectiveness and patient-specific needs.