Cerapedics Print Logo

Frequently Asked Questions

What is an integrin?

An integrin is signaling receptor that regulates attachment between a cell and the tissues surrounding it, which can be other cells or the extracellular matrix (ECM). Because integrins participate in cell signaling, they help define cellular shape and mobility as well as regulate the cell cycle. There are multiple integrin types and quantities per cell.

Do all cells in the osteogenic lineage have integrins?

Yes- mesenchymal stem cells (MSCs), osteogenic precursor cells, and osteoblasts all have the α2β1 integrin present. For this reason, i-FACTOR™ can stimulate the bone formation process by attracting the maximum amount of cells to build new bone.

Who discovered the peptide responsible for osteogenic cell attachment?

In the early 1990's, Raj Bhatnager, PhD (UCSF) identified the 15 amino acid sequence (766GTPGPQGIAGQRGVV780) as the part of Type 1 human collagen to which the α2β1 osteogenic cell integrin attaches.

Is i-FACTOR a Bone Morphogenic Protein (BMP)?

i-FACTOR is a biologic bone graft but it is not a BMP. The ability of P-15™ to enhance cell attachment stimulates natural signaling, similar to the body's own bone regeneration process. Because of how it interacts with cells, i-FACTOR only works in the presence of stem cells or cells of an osteogenic lineage that are sourced from the surrounding host bone. Commercially available growth factors work by the addition of exogenous factors such as rhBMP-2 and rhBMP-7 resulting in cellular differentiation and subsequent bone formation. The chart below highlights how i-FACTOR and growth factor products play different roles in bone formation.

Cascade of Events Leading to Bone Formation

Morphogenic growth factors have the ability to change many types of cells into bone cells as the way of initiating the process of new bone formation.  i-FACTOR will only stimulate a healing response in the presence of bone forming cells, minimizing the likelihood for ectopic bone growth.

Why does Cerapedics use ABM?

P-15 readily adsorbs to ABM.  Not all synthetic calcium phosphates have surface properties that allow for successful coating with P-15. ABM is a safe natural calcium phosphate matrix that allows Cerapedics the opportunity to exploit the powerful biologic properties of P-15 to provide a superior bone graft substitute material to the spine, trauma, and orthopedic community.

Is there a risk of mad cow disease (TSE) from bovine derived products?

Many bone graft products, including some collagen sponges, use bovine derived components. Two published references have concluded that the use of bovine derived bone products (i) "does not carry a risk of transmitting BSE to patients"; (ii) is an "insignificant risk". The references are:

i.    "Analysis of the risk of transmitting bovine spongiform encephalopathy through bone grafts derived from bovine bone."  Wenz B, Oesch B, Horst M.  Biomaterials 22 (2001) 1599-1606.
ii.    "Risk assessment of bovine spongiform encephalopathy transmission through bone graft material derived from bovine bone used for dental applications."  Sogal A, Tofe AJ.  J of Periodontology 1999; 70:1053-1063.

Cerapedics processes the ABM so that any potential Transmissible Spongiform Enchephalopathies (TSE) causative prions (proteins) are removed, therefore no "Mad Cow Disease". Additionally, in order for i-FACTOR to receive a CE Mark, it had to pass a mandatory 12 week review and receive approval by all EU members on the use of animal tissue in the product. CE Mark qualifies the product as safe for clinical use. Finally, Cerapedics has received a TSE certificate. This is a separate optional review of the use of animal tissue done by the European Directorate for the Quality of Medicines and Health Care that declares ABM is acceptable for human use.