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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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3 Bone Morphogenetic Proteins and Orthopedic Repair
Pages 14-17

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From page 14...
... We also know that BMPs function in bone formation by recruiting mesenchymal progenitor cells and initiating endochondral ossification in heterotopic sites, that they stimulate osteogenesis in orthotopic sites by acting on multiple cell types, and that they not only affect processes related to bone formation but also are actively involved in the formation of other musculoskeletal tissues as well as nonskeletal tissues such as the kidney and the cardiovascular system. Research today on BMPs focuses on mesenchymal stem cells (MSCs)
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From page 15...
... PRODUCT DEVELOPMENT PROCESS FOR A BONE MORPHOGENETIC PROTEIN COMBINATION PRODUCT William McKay Medtronic Sofamor Danek On July 2, 2002, the U.S. Food and Drug Administration (FDA)
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From page 16...
... CT scans have become the gold standard in assessing bone formation and quality. Less stringent FDA clearances for use of the identical bone graft replacement product in expanded clinical bone grafting indications would significantly accelerate the process development.
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From page 17...
... . TABLE 1 Recommended FDA Approval Processes for Use of Same Product in Expanded Clinical Indications BMP Approval Technique Concentration Carrier process Interbody fusion 1.5 mg/ml Collagen sponge New PMA (LT CAGETM)
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Key Terms

  • bone morphogenetic
  • bone formation
  • morphogenetic protein
  • bone grafting
  • morphogenetic proteins

  • graft replacement
  • fda approval
  • bone biology
  • interbody fusion
  • cell types

  • orthopedic repair
  • prospective randomized
  • biologic medical
  • grafting procedure
  • nonhuman primate

  • combination biologic
  • clinical data
  • protein combination
  • human bone
  • progenitor cells

  • randomized clinical
  • medical device
  • growth factor
  • combination product
  • expanded clinical

  • pma supplement
  • primate bone
  • multiple cell
  • studies using
  • grafting indications


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