Bone · FDA Approved
BMP-2 (Bone Morphogenetic Protein-2)
FDA-approved
01 · Overview
BMP-2 is a member of the transforming growth factor-beta superfamily and functions as a homodimeric protein. It binds type I and type II serine and threonine kinase receptors on mesenchymal cells, activating SMAD-dependent signaling that induces osteoblastic differentiation and bone formation.
Recombinant human BMP-2 is delivered on an absorbable collagen sponge carrier to provide sustained local release at the intended site of bone growth. It is a potent osteoinductive agent approved by the FDA as a device for specified spinal fusion and open tibial fracture indications and remains in orthopedic and dental use.
02 · Research summary & key findings
An independent systematic review and meta-analysis using individual patient data from industry-sponsored studies found that for lumbar spine fusion, recombinant human BMP-2 and iliac crest bone graft were similar in overall success, fusion and other effectiveness measures, and similar in the risk of any adverse event, and it also documented reporting bias in the original industry publications (PMID 23778906). Pooled data from five randomized FDA investigational device exemption studies found retrograde ejaculation in 3.4 percent of men who received recombinant human BMP-2 versus 1.7 percent of controls, a difference that was not statistically significant (PMID 23199378). Concerns about off-label use and local complications have been raised in the post-marketing literature.
03 · Regulatory status
BMP-2 (Bone Morphogenetic Protein-2) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
BMP-2 (Bone Morphogenetic Protein-2) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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BMP-2 (Bone Morphogenetic Protein-2) is prescribed for the conditions on its label, and it is not part of our intake. If you are working on injury recovery and tissue repair, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Surgical implantation
References
- [1]Retrograde ejaculation following single-level anterior lumbar surgery with or without recombinant human bone morphogenetic protein-2 in 5 randomized controlled trials: clinical article J Neurosurg Spine, 2013. PMID 23199378
- [2]Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis Ann Intern Med, 2013. PMID 23778906
Primary literature
- PubMed: "BMP-2"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "BMP-2"
Registered interventional and observational studies, including status and phase.
- PubChem: "BMP-2"
Chemical structure, molecular properties, and bioactivity data.
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