BMP-7
/ Recombinant human bone morphogenetic protein (TGF-β superfamily ligand)ALIAS · Bone Morphogenetic Protein-7 · OP-1 (Osteogenic Protein-1) · rhBMP-7 · Eptotermin alfa
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Approved under FDA Humanitarian Device Exemption (HDE) 2001 for tibial nonunion (Stryker OP-1 Implant); HDE for posterolateral lumbar fusion 2004. Both products subsequently voluntarily withdrawn from the US market — BMP-7 is no longer commercially available as an approved orthobiologic in the US, though the underlying clinical evidence base remains tier 1.
BMP-7 is a homodimeric TGF-β-superfamily ligand that signals through type I and type II serine/threonine kinase receptors (BMPR-IA, BMPR-IB, BMPR-II) to phosphorylate SMAD1/5/8, complexing with SMAD4 and inducing transcription of osteogenic master regulators including RUNX2 and Osterix. The downstream effect is differentiation of mesenchymal progenitor cells along the osteoblastic lineage, plus chemotaxis of MSCs to the implantation site.
Beyond skeletal applications, BMP-7 has demonstrated antifibrotic effects in renal models (counter-regulating TGF-β1 in proximal tubule cells) but no recombinant-protein product reached approval for renal indications.
Tier 1 originally — pivotal Friedlaender 2001 RCT of 122 patients showed equivalence to iliac crest autograft for tibial nonunion at 9 and 24 months, supporting HDE approval. The Vaccaro 2008 lumbar fusion trial (n=295) failed to demonstrate statistical equivalence at the protocol-defined success threshold; Stryker subsequently voluntarily withdrew OP-1 Implant and OP-1 Putty from the US market. As of 2026, BMP-7 is not commercially available as an FDA-approved orthobiologic in the US.
In the approved orthopedic indications, common adverse events were heterotopic ossification, post-operative seroma, and immunogenicity (anti-BMP-7 antibodies developed in a minority of patients but were not associated with loss of efficacy). The BMP class as a whole has been associated with rare but serious post-marketing reports of cervical spine swelling when used off-label in cervical fusion (an FDA Public Health Notification originally addressed BMP-2 specifically; off-label cervical use of any BMP is discouraged).
Regulatory status
- FDA status:
- Previously approved, discontinued
BMP-7 is no longer commercially available in the US as an approved orthobiologic — Stryker withdrew the OP-1 product line. Research-grade rhBMP-7 sold by peptide vendors is not derived from the approved manufacturing process; lot-to-lot variability is unverified.
The competitor product BMP-2 (Medtronic Infuse) remains FDA-approved for specific spinal indications but has been the subject of high-profile concerns about industry influence on clinical literature (Yale Open Data Access reanalysis 2013). These concerns colour reading of the BMP-7 trial record by proxy and warrant caution when interpreting vendor-promoted research claims.