Recovery · FDA Approved
OP-1 / BMP-7
FDA-approved
01 · Overview
OP-1, or osteogenic protein-1, is the recombinant form of bone morphogenetic protein-7 (BMP-7), a member of the transforming growth factor-beta superfamily. This protein induces differentiation of mesenchymal stem cells into bone-forming cells, stimulating new bone formation.
It was developed as an alternative to autologous bone graft for long bone nonunions and spinal fusion (PMID 16831023).
02 · Research summary & key findings
The FDA granted OP-1 a Humanitarian Device Exemption, a device rather than drug approval, as an alternative to autograft in recalcitrant long bone nonunions where autograft is unfeasible and other treatments have failed (PMID 23074475), and a separate exemption for spinal applications (PMID 16831023). In a randomized trial of 122 patients with tibial nonunions, 81 percent of OP-1-treated and 85 percent of autograft-treated nonunions were clinically successful at 9 months, a difference that was not statistically significant (PMID 11314793). BMP-7 has since been withdrawn from the market (PMID 34702541).
03 · Regulatory status
OP-1 / BMP-7 has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
OP-1 / BMP-7 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.
Looking for a lawful, clinician-prescribed option for injury recovery and tissue repair?
OP-1 / BMP-7 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
- Implantation at surgical site
References
- [1]Osteogenic protein-1 (bone morphogenetic protein-7) in the treatment of tibial nonunions J Bone Joint Surg Am, 2001. PMID 11314793
- [2]Osteogenic protein-1 : a review of its utility in spinal applications BioDrugs, 2006. PMID 16831023
- [3]Osteogenic protein-1 for long bone nonunion: an evidence-based analysis Ont Health Technol Assess Ser, 2005. PMID 23074475
- [4]FDA-approved bone grafts and bone graft substitute devices in bone regeneration Mater Sci Eng C Mater Biol Appl, 2021. PMID 34702541
Primary literature
- PubMed: "OP-1 / BMP-7"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "OP-1 / BMP-7"
Registered interventional and observational studies, including status and phase.
- PubChem: "OP-1 / BMP-7"
Chemical structure, molecular properties, and bioactivity data.
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