BoneFDA Approved

BMP-7 (Osteogenic Protein-1)

Overview

BMP-7, also known as osteogenic protein-1 (OP-1), is a member of the bone morphogenetic protein family with a mature homodimeric structure of approximately 139 amino acids per monomer. Like other BMPs, it signals through serine/threonine kinase receptors to activate SMAD transcription factors, promoting differentiation of mesenchymal cells into osteoblasts and chondrocytes. The recombinant form is delivered on a bovine collagen matrix to provide localized, sustained release. BMP-7 also exhibits renoprotective effects in preclinical models, though clinical development in nephrology has not advanced.

Key Research Findings

Recombinant human BMP-7 (OP-1 Putty) received FDA approval under a Humanitarian Device Exemption in 2001 for revision posterolateral lumbar spinal fusion and recalcitrant long bone nonunions where autograft is not feasible. Clinical trials demonstrated comparable efficacy to autograft in promoting bone healing in nonunion fractures. The product was voluntarily withdrawn from the U.S. market in 2014 by the manufacturer due to commercial considerations, though it remains available in select international markets.

Route of Administration

Surgical implantation

Regulatory Status

FDA Approved

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