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  • adverse events
  • In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. (semanticscholar.org)
  • Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. (semanticscholar.org)
  • CONCLUSIONS Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. (semanticscholar.org)
  • This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications. (semanticscholar.org)
  • Anterior
  • After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. (semanticscholar.org)
  • subsequently
  • PURPOSE To compare the conclusions regarding the safety and related efficacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases. (semanticscholar.org)
  • Smad
  • BMP signaling is induced when a heterodimeric membrane kinase binds BMP and subsequently triggers Smad protein phosphorylation, similar to the mechanism of TGF-β pathway activation. (spandidos-publications.com)
  • BMP-2 treatment in 5-AzadC-treated normal chondrocytes resulted in SOST upregulation, which was mediated through Smad 1/5/8 binding on the CpG region of SOST promoter. (biomedcentral.com)
  • exogenous
  • Xenograft orthotopic murine models were used to assess the effects of exogenous and endogenous elevations in BMP-2 signaling on tumour growth and metastasis. (ucalgary.ca)
  • genes
  • Notably, we found that HSC-4 cells were the most responsive to BMP-2 stimulation, which resulted in the upregulation of Smad1/5/9 target genes such as the MET inducers ID1 and cytokeratin 9 (CK9). (spandidos-publications.com)
  • stimulates bone
  • Introduction: Suture expansion stimulates bone growth to correct craniofacial deficiencies but has a high potential of treatment relapse. (bioquant.com)
  • formation
  • BMP-2 proteins are further characterized by the ability to induce the formation of cartilage and/or bone. (google.com)
  • Members of the BMP-2A protein family may be further characterized by the ability to demonstrate cartilage and/or bone formation activity in the rat bone formation assay described below. (google.com)
  • In preferred embodiments, the proteins of the invention demonstrate activity in this rat bone formation assay at a concentration of 0.5 μg -100 μg/gram of bone. (google.com)
  • In 1965, Urist 14) discovered a subset of protein extract, which had a significant potential of inducing new bone formation even at the non-osseous tissues. (e-neurospine.org)
  • Although high-dose rhBMP-2 treatment led to an advanced radiological fusion result compared to autograft treatment, heterotopic bone formation and vertebral bone resorption were induced simultaneously. (scienceopen.com)
  • Despite qualitative alteration of the trabecular bone structure within the fusion site, the massive anterior heterotopic bone formation led to a substantial increase in mechanical stiffness compared to the autograft group. (scienceopen.com)
  • Cysteine rich heterologous protein production in prokaryotic systems leads to inclusion body formation and protein aggregation 4,5 . (ajmb.org)
  • Therefore formation of a SAM containing both the scaffold protein and an amphiphile produces a surface where the orientation of the protein is controlled and non-specific interactions are low. (biomedcentral.com)
  • INFUSE
  • 4) and in their letter they proposed that the containment of low dose (1.05 mg) rhBMP-2 within the cage and placing demineralized bone matrix (DBM) putty surrounding the INFUSE ensures a controlled delivery of rhBMP-2 in the vicinity of desired fusion site, which therefore is associated with excellent fusion rates with no adverse effects related to rhBMP-2. (e-neurospine.org)
  • inducer
  • However, BMP-2/7 was not found to be a stronger inducer of osteogenesis compared to homodimeric either BMP-2 or BMP-7. (uva.nl)
  • vivo
  • Heterodimeric BMP-2/7 significantly promoted osteogenesis of hASCs in vitro and in vivo. (uva.nl)
  • We assessed the oncologic consequences of BMP-2 signalling on osteosarcoma in vitro and in vivo. (ucalgary.ca)
  • spine fusion
  • For anterior cervical spine fusion, rhBMP-2 was associated with increased risk for wound complications and dysphagia. (nih.gov)
  • From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. (semanticscholar.org)
  • pathways
  • The aim of the study was to investigate the possible cross-talk between BMP-2 and Wnt/β-catenin pathways in OA progression. (biomedcentral.com)
  • spinal fusion
  • To independently assess the effectiveness and harms of rhBMP-2 in spinal fusion and reporting bias in industry-sponsored journal publications. (nih.gov)
  • We hypothesized that a high dose of rhBMP-2 in cervical spinal fusion could induce substantial alterations in bone, leading to mechanical impairment. (scienceopen.com)
  • In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. (semanticscholar.org)
  • CONCLUSIONS Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. (semanticscholar.org)
  • Purification
  • However, inclusion body aggregation and refolding process limits production and purification of recombinant BMP-2 in bacterial systems. (ajmb.org)
  • The aggregated and monomeric BMP-2 was refolded and purified comparing two oxidoreductase systems and refolding methods as well as different purification techniques. (ajmb.org)
  • Since they are enclosed in inclusion bodies, purification of aggregated proteins is rather a convenient process while their refolding is a laborious and time-consuming procedure. (ajmb.org)
  • analyses
  • METHODS Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efficacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses. (semanticscholar.org)
  • RESULTS There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. (semanticscholar.org)
  • limb
  • Impaired bone healing biology in osteosarcoma patients contributes to significant local complications following limb salvage surgery. (ucalgary.ca)
  • Gene
  • Mutations in the gene-encoding SERCA1, the fast-twitch skeletal muscle sarcoplasmic reticulum Ca 2+ ATPase, are associated with Brody disease," Nature Genetics , vol. 14, no. 2, pp. 191-194, 1996. (hindawi.com)
  • sponge
  • A low-dose rhBMP-2 (0.7mg/level) sponge was placed exclusively within the cage. (e-neurospine.org)
  • In 102 patients demineralized bone matrix (DBM) was filled around the BMP sponge. (e-neurospine.org)
  • Packing DBM putty around the BMP sponge does not affect the safety profile of rhBMP-2 in ACFs. (e-neurospine.org)
  • lumbar
  • For anterior lumbar interbody fusion, rhBMP-2 was associated with nonsignificantly increased risk for retrograde ejaculation and urogenital problems. (nih.gov)
  • Although, their role in lumbar fusions is well established, the safety profile of rhBMP-2 in ACFs is yet to be defined 10 11 13) . (e-neurospine.org)
  • After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. (semanticscholar.org)
  • Sodium
  • Western Blotting refers to the electrophoretic transfer of proteins from sodium dodecyl sulfate polyacrylamide gels to sheets of PVDF or nitrocellullose membrane, followed by immunodetection of prote. (sigmaaldrich.com)
  • amino acids
  • b) recovering and purifying from said culture medium a protein comprising amino acids #283-#396 of FIG. 2. (google.com)
  • b) recovering and purifying from said culture medium a protein comprising amino acids #283 to #396 of FIG. 2. (google.com)
  • 7. A composition comprising a purified protein characterized by amino acids #283 to #396 of FIG. 2. (google.com)
  • The mature BMP-2 is a disulfide -connected homodimer, composed of 114 amino acids derived from the C-terminal sequence of a 396 amino acid precursor polypeptide. (ajmb.org)
  • A protein was engineered to contain a C-terminal cysteine that would allow chemisorption to gold, followed by 12 amino acids that form a water soluble coil that could switch to a hydrophobic helix in the presence of alkane thiols. (biomedcentral.com)
  • cancer
  • At 24 months, the cancer risk was increased with rhBMP-2 (risk ratio, 3.45 [95% CI, 1.98 to 6., but event rates were low and cancer was heterogeneous. (nih.gov)