Tissue engineering - Orthopaedic Biomaterials in Research and Practice - page 243

D. From genetically identical donors
E. From the same individual in which the cells will be reimplanted
ANSWER:
Allogenic, C ; autologous, E ; xenogenic, A ; stem cells, B ; syngenic, D .
PROBLEM 9.2
Which of these are not ethical concerns regarding tissue-engineered
products?
A. Patient consent for cell donation
B. Cost/value of the cells
C. Ownership of the cells
D. Safety and efficacy
E. Scaleability
ANSWER:
E —scaleability refers to questions regarding the practicality and com-
mercializability of tissue-engineered products.
PROBLEM 9.3
How is the regulatory pathway for a tissue-engineered product
determined?
A. Types of cells used in the product
B. Manufacturing method
C. Intended use/application
D. Primary mode of action
E. Level of biocompatibility
ANSWER:
D —the PMOA is the mode through which the product achieves its ther-
apeutic effect. Since there are three primary centers at the FDA that
regulate medical products, the center that is responsible for leading the
review process is based on the PMOA.
annotated bibliography
1. American Academy of Orthopaedic Surgeons: Information
Statement—Tissue-Engineered and Cell-Based Medical Products, 2008.
This provides perspective on the use of tissue-engineered and cell-based
products in orthopaedics.
2. ASTM F2027: Standard Guide for Characterization and Testing of Raw or
Starting Biomaterials for Tissue-Engineered Medical Products. American
Society for Testing and Materials, West Conshohocken, PA.