Bone tissue engineering is concerned with creating implantable bone substitutes for critical skeletal defects that cannot heal on their own. These defects are common clinical scenarios in orthopedics and craniofacial surgery, for the treatment of bone loss due to trauma, infection, and tumor resection. In the conventional tissue-engineering paradigm, combinations of cells and bioactive molecules are seeded onto three-dimensional biomaterial scaffolds to create an implantable 'osteogenic' implant. To date and despite numerous exciting advances in preclinical models, regulatory approval barriers, business challenges, and related intellectual property lifecycle issues have impeded clinical translation from the bench to the bedside. Despite these hurdles, there are clinical case reports of ingenious reconstructions of challenging diaphyseal and craniofacial defects that borrow from first principles of conventional tissue engineering, but circumvent the regulatory process via '. off-. label' use of several approved products at the point-. of-. care. While placebo-controlled, prospective clinical studies of efficacy and safety still needs to be pursued for bone tissue engineering, these point-. of-. care innovations usher in the era of personalized regenerative medicine, and may serve as the bridge to wide clinical translatability and adoption of bone tissue-engineering approaches and products. Novel molecules that regenerate bone in clinically relevant defects are being developed and, when successfully launched, will act as bone healing agents.

Original languageEnglish
Title of host publicationPrinciples of Tissue Engineering
Subtitle of host publicationFourth Edition
PublisherElsevier Inc.
Number of pages11
ISBN (Print)9780123983589
StatePublished - Nov 2013


  • Bioactive molecule
  • Biomaterial
  • Bone
  • Craniofacial surgery
  • Implant
  • Orthopedics
  • Osteogenic
  • Regenerative capability
  • Skeletal defects
  • Three-dimensional scaffold
  • Tissue engineering


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