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Proceedings from the Workshop on Science-Based Assessment Accelerating Product Development of Combination Medical Devices (2004) / Chapter Skim
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5 Cell-Matrix Cartilage Implants
Pages 21-26

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 21...
... Focal defects are frequently due to traumatic injury; if left untreated, over 80 percent of patients with focal traumatic defects will develop arthritis an average of 20 years after the injury. Generalized damage due to osteoarthritis is the biggest clinical manifestation of articular cartilage damage, with virtually 100 percent of patients over the age of 50 showing some degree of erosion.
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From page 22...
... The information gained from this procedure, however -- including direct visualization of the tissue and a needle biopsy for histological examination of cell density and distribution, collagen patterns, and proteoglycans -- is definitive confirmation of a successful reconstruction. Perhaps a balance can be achieved between the ethical considerations and the scientific merit of such follow-up procedures by utilizing a subset population in a study design.
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From page 23...
... Some of the greatest challenges encountered were in the preclinical and clinical areas where Genzyme sought improved healing and reduced rehabilitation time for patients, simplification of the surgical procedure with reduced morbidity using minimally invasive techniques, and development of test systems that provide meaningful data to make rapid decisions regarding next-generation product development. For a business, increased product utility, reduced time to market, and increased product adoption are impor 23
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From page 24...
... However, some technical challenges remain: the provision of a cell source that provides enough cells with appropriate phenotype has yet to be identified; the mechanical properties of constructs are inferior to those of native cartilage; and lateral integration with surrounding host articular cartilage has yet to be achieved. The importance of these factors is unknown.
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From page 25...
... Finally, a successful business must be created in an uncertain environment where the realistic size of the market, reimbursement of the product, and time to market acceptance and profitability are significant issues. In the area of cartilage repair, the size of the market for focal defects will most likely be modest.
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Key Terms

  • clinical studies
  • articular cartilage
  • surgical procedure
  • increased product
  • significant issues

  • aggrecan proteoglycan
  • lateral integration
  • structural repair
  • dedicated effort
  • focal defects

  • efficiently move
  • international agreement
  • focal traumatic
  • living autologous
  • manufacturing practices

  • patient age
  • situation requires
  • definitive confirmation
  • improved healing
  • clinical outcome

  • cell density
  • demonstrate compliance
  • trial design
  • rapid decisions
  • issues regarding

  • meaningful data
  • appropriate clinical
  • additional discomfort
  • regulates assembly
  • histological examination


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