Off-Label Use of Bone Morphogenetic Proteins in the United States Using Administrative Data

Ong, Kevin; Villarraga, Marta L.; Lau, Edmund; Carreon, Leah Y.; Kurtz, Steven M.; Glassman, Steven D.

doi:10.1097/brs.0b013e3181ecf6e4

Cited by 261 publications

(168 citation statements)

References 33 publications

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“…We chose to use BMP-2 in this study based on the fact that BMP-2 has received FDA approval for bone regeneration (Ong et al 2010) and has been shown to promote dentin formation (Wang et al 2016). The fact that we found no calcified dental tissue formation in any BMP-2-loaded dTB implants emphasizes the importance of added cells for tooth regeneration in this model.…”

Section: Discussionmentioning

confidence: 99%

Decellularized Tooth Bud Scaffolds for Tooth Regeneration

et al. 2017

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Whole tooth regeneration approaches currently are limited by our inability to bioengineer full-sized, living replacement teeth. Recently, decellularized organ scaffolds have shown promise for applications in regenerative medicine by providing a natural extracellular matrix environment that promotes cell attachment and tissue-specific differentiation leading to full-sized organ regeneration. We hypothesize that decellularized tooth buds (dTBs) created from unerupted porcine tooth buds (TBs) can be used to guide reseeded dental cell differentiation to form whole bioengineered teeth, thereby providing a potential off-the-shelf scaffold for whole tooth regeneration. Porcine TBs were harvested from discarded 6-mo-old pig jaws, and decellularized by successive sodium dodecyl sulfate/Triton-X cycles. Four types of replicate implants were used in this study: 1) acellular dTBs; 2) recellularized dTBs seeded with porcine dental epithelial cells, human dental pulp cells, and human umbilical vein endothelial cells (recell-dTBs); 3) dTBs seeded with bone morphogenetic protein (BMP)-2 (dTB-BMPs); and 4) freshly isolated nondecellularized natural TBs (nTBs). Replicate samples were implanted into the mandibles of host Yucatan mini-pigs and grown for 3 or 6 mo. Harvested mandibles with implanted TB constructs were fixed in formalin, decalcified, embedded in paraffin, sectioned, and analyzed via histological methods. Micro-computed tomography (CT) analysis was performed on harvested 6-mo samples prior to decalcification. All harvested constructs exhibited a high degree of cellularity. Significant production of organized dentin and enamel-like tissues was observed in dTB-recell and nTB implants, but not in dTB or dTB-BMP implants. Micro-CT analyses of 6-mo implants showed the formation of organized, bioengineered teeth of comparable size to natural teeth. To our knowledge, these results are the first to describe the potential use of dTBs for functional whole tooth regeneration.

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Section: Discussionmentioning

confidence: 99%

Decellularized Tooth Bud Scaffolds for Tooth Regeneration

et al. 2017

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“…Friedlaender et al (2001) demonstrated safe application of BMP-7 in vivo with non-union healing comparable to autograft controls. Together, these studies pioneered BMP-7 use in vivo and led to FDA approval for use in long bone non-unions in 2001 and posterolateral lumbar fusions in 2004 (Ong et al, 2010). Regarding lumbar fusion surgery, BMP-7 was delivered at 3.5 mg per vertebral side (7 mg in total).…”

Section: Bmp-7/op-1mentioning

confidence: 99%

Tissue engineered bone using select growth factors: A comprehensive review of animal studies and clinical translation studies in man

Gothard¹,

Smith²,

Kanczler³

et al. 2014

eCM

162

125

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“…Despite its off-label use, 30.0% of BMP use is in primary TLIF/ PLIF procedures and 20.4% of BMP is used in primary posterolateral spinal fusions [20]. Hence, the use of BMP for lumbar spinal fusions can be considered as an optional "standard of care" before the FDA has granted approval [20].…”

Section: Discussionmentioning

confidence: 99%

Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) in Posterolateral Lumbar Spine Fusion: Complications in the Elderly

Hoffmann

Jones

2011

The Spine Journal

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Study design: Retrospective cohort study of 1430 patients undergoing lumbar spinal fusion from 2002 -2009. Objective: The goal of this study was to compare and evaluate the number of complications requiring reoperation in elderly versus younger patients. Summary of background data: rhBMP-2 has been utilized off label for instrumented lumbar posterolateral fusions for many years. Many series have demonstrated predictable healing rates and reoperations. Varying complication rates in elderly patients have been reported. Materials and methods:All patients undergoing instrumented lumbar posterolateral fusion of ≤ 3 levels consenting to utilization of rhBMP-2 were retrospectively evaluated. Patient demographics, body mass index, comorbidities, number of levels, associated interbody fusion, and types of bone void filler were analyzed. The age of patients were divided into less than 65 and greater than or equal to 65 years. Complications related to the performed procedure were recorded. Results: After exclusions, 482 consecutive patients were evaluated with 42.1% males and 57.9% females. Average age was 62 years with 250 (51.9%) < 65 and 232 (48.1%) ≥ 65 years. Patients ≥ 65 years of age stayed longer (5.0 days) in the hospital than younger patients (4.5 days) (p=0.005). Complications requiring reoperation were: acute seroma formation requiring decompression 15/482, 3.1%, bone overgrowth 4/482, 0.8%, infection requiring debridement 11/482, 2.3%, and revision fusion for symptomatic nonunion 18/482, 3.7%. No significant differences in complications were diagnosed between the two age groups. Statistical differences were noted between the age groups for medical comorbidities and surgical procedures. Patients older than 65 years underwent longer fusions (2.1 versus 1.7 levels, p=0.001).Discussion: Despite being older and having more comorbidities, elderly patients have similar complication and reoperation rates compared to younger healthier patients undergoing instrumented lumbar decompression fusions with rhBMP-2.

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Off-Label Use of Bone Morphogenetic Proteins in the United States Using Administrative Data

Cited by 261 publications

References 33 publications

Decellularized Tooth Bud Scaffolds for Tooth Regeneration

Decellularized Tooth Bud Scaffolds for Tooth Regeneration

Tissue engineered bone using select growth factors: A comprehensive review of animal studies and clinical translation studies in man

Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) in Posterolateral Lumbar Spine Fusion: Complications in the Elderly

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