Bone Morphogenetic Proteins

Bone morphogenetic proteins (BMPs) are naturally occurring proteins found in the human body. This family of proteins is involved in a myriad of cellular responses. Certain BMPs are osteoinductive—one of the three main categories of bone grafts—and play an active role in bone formation and maintenance.

INFUSE Synthetics BMPs

The human sequence of these proteins may be synthetically manufactured in a consistent, controlled process—commonly referred to as recombinant technology, hence the name "rhBMP" (recombinant human bone morphogenetic protein).

To date, nearly 20 different BMPs have been discovered, but only BMPs 2, 4, 6, 7 and 9 have been proven to play significant roles in bone formation.1 Unlike ceramic and demineralized bone matrix technologies that serve as bone void fillers or autograft extenders, BMPs are highly osteoinductive and must go through rigorous preclinical and clinical trials prior to Premarket Approval (PMA) by the U.S. Food and Drug Administration (FDA).

BMP-2

BMP-2 is one of the most potent growth factors that induces mesenchymal stem cell (MSC) and osteoprogenitor cell differentiation into osteoblasts.1 rhBMP-2 is the only highly osteoinductive bone graft that has been tested and approved by the FDA as an alternative to autograft in multiple clinical studies via the PMA process.

rhBMP-2 has achieved safety and effectiveness results equivalent to the standard of care in certain lumbar spine, orthopedic trauma or oral-maxillofacial procedures.3-6 In addition, rhBMP-2 has more Level 1 clinical evidence than any other bone grafting material.2

INFUSE Bone Morphogenetic
Histology images from non-human primate interbody fusion at 6 months.7
Preclinical animal models do not extrapolate to clinical efficacy.

BMP-7

BMP-7, has minimal effect on MSCs, but targets "partially committed" osteoblast precursors and induces their differentiation into osteoblasts.1 Therefore, BMP-2 may be more potent than BMP-7 as a bone forming agent due to its ability to induce both early and late osteogenic activity and matrix mineralization.1 BMP-7 assists primarily in later stages of bone formation.1 rhBMP-7 has not proven effectiveness and has therefore only received Humanitarian Device Exemption approval from the FDA.

References

  1. Cheng H, Jiang W, Phillips FM, Haydon RC, et al. Osteogenic activity of the fourteen types of human bone morphogenetic proteins (BMPs). J Bone Joint Surg Am. 2003;85:1544-1552.
  2. Resnick DK et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes. J Neurosurg: Spine, Vol. 2, June 2005.
  3. Burkus, et al. Anterior Lumbar Interbody Fusion Using rhBMP-2 With Tapered Interbody Cages. J Spinal Disorders. 2002; 15(5): 337-349.
  4. Boyne PJ, Lilly LC, et al. De Novo Bone Induction by Recombinant Human Morphogenetic Protein-2 (rhBMP-2) in Maxillary Sinus Floor Augmentation. J Oral Maxillofac Surg. 2005;63:1693-1707.
  5. Fiorellini JP, Howell TH, et al. Randomized Study Evaluating Recombinant Human Bone Morphogenetic Protein-2 for Extraction Socket Augmentation. J Periodontol. 2005; 76(4): 605-613.
  6. Friedlaender, et al. Osteogenic Protein-1 (Bone Morphogenetic Protein-7) in the Treatment of Tibial Nonunions: A Prospective, Randomized Clinical Trial Comparing rhOP-1 with Fresh Bone Autograft. J Bone Joint Surg Am. 2001; 83-A Suppl 1(Pt 2): S151-S158.
  7. Boden et al. Laparoscopic Anterior Spinal Arthrosesis with rhBMP-2 in a Titanium Interbody Threaded Cage. J of Spinal Disord. 1998; 11(2):95-101.