Tissue engineering - Orthopaedic Biomaterials in Research and Practice - page 244

Guidance on writing materials specification for raw or starting biomate-
rials, which are intended for use in tissue engineering scaffolds for growth,
support, or delivery of cells and/or biomolecules.
3. ASTM F2150: Standard Guide for Characterization and Testing of
Biomaterial Scaffolds Used in Tissue-Engineered Medical Products.
American Society for Testing and Materials, West Conshohocken, PA.
Guidance for the characterization and testing of biomaterials after they
have been formed into three-dimensional scaffolds.
4. Khan WS, Rayan F, Dhinsa BS, Marsh D: An osteoconductive,
osteoinductive, and osteogenic tissue-engineered product for trauma and
orthopaedic surgery: how far are we? Stem Cells Int , article ID 236231,
2012.
Describes the principles of tissue engineering of bone and its clinical
application in reconstructive surgery.
5. Khan WS, Longo UG, Adesida A, Denaro V: Stem cell and
tissue engineering applications in orthopaedics and musculoskeletal medi-
cine. Stem Cells Int , article ID 403170, 2012.
Brief summary of the use of stem cells.
6. Lee MH, Arcidiacono JA, Bilek AM, Wille JJ, Hamill
CA, Wonnacott KM, Wells MA, Oh SS: Considerations for
tissue-engineered and regenerative medicine product development prior to
clinical trials in the United States. Tissue Eng Part B Rev 16:41-54, 2010.
Provides product developers in the early stages of product development
with insight into the Food and Drug Administration process.
7. Meyer U: The history of tissue engineering and regenerative medicine
in perspective. In Meyer U, Meyer Th, Handschel J, Wiesmann HP (eds):
Fundamentals of Tissue Engineering and Regenerative Medicine . Springer
Berlin Heidelberg, Leipzig, Germany, 2009.
History of tissue engineering and perspectives on its future.
8. Ong KL, Villarraga ML, Lau E, Carreon LY, Kurtz SM,
Glass SD: Off-label use of bone morphogenetic proteins in the United
States using administrative data. Spine 35: 1794-1800, 2010.
Background on the historical on-label and off-label utilization of BMP
in the United States.
9. Trice ME, Bugbee WD, Greenwald AS, Heim CS: Articular
cartilage restoration: a review of currently available methods. Committee on
Biological Implants Scientific Exhibit. American Academy of Orthopaedic
Surgeons, 77th Annual Meeting, Mar 9-13, 2010, New Orleans, LA.
A review on four most commonly employed cartilage repair techniques
with rational, basic science, and indications.
10. 21 C F R Part 1270: Human tissue intended for transplantation.
Regulations related to banked human tissue.
11. 21 C F R Part 1271: Human cells, tissues, and cellular and tissue-based
products.
Regulations to establish donor-eligibility, current good tissue practice,
and other procedures to prevent the introduction, transmission, and spread
of communicable diseases by human cells, tissues, and cellular and tissue-
based products.