|
| |
Preclinical Scientific Evaluations of OsteoSponge
Evidence for Osteoinductive and Osteoconductive
Properties
In Vivo Studies (Heterotopic -Bone Growth
Model)
|
Bacterin has performed several studies using
a heterotopic bone growth model in athymic mice to test the
osteoinductive properties of OsteoSponge™, OsteoSponge™ is prepared
using methods that preserve native growth factors contained within the
collagen matrix, Neovascularization, osteoid formation and new bone
growth has been consistently observed in subcutaneously-implanted
OsteoSponge™ The results suggest
that in addition to providing an excellent natural scaffold for cellular
ingrowth and proliferation, OsteoSponge™ also contains growth factors.
Growth factors signal infiltrating host cells to initiate the formation
of new blood vessels and to differentiate into osteoclasts and
osteoblasts. This combination of signaling and structure ultimately
leads to the formation of new bone.
|
Endogenous Native Growth Factors in
OsteoSponge™
|
Characterization of the native growth factor
content of OsteoSponge™ aids in understanding its osteoinductive
activity. To evaluate the levels of endogenous growth factors in
OsteoSponge™, Enzyme-Linked Immunosorbent Assays (ELISAS) were used to
measure the levels of native growth factors, including human bone
morphogenic proteins (hBMPs), in extracts of OsteoSponge™ blocks
processed from a 27 year old male donor. Shown in Table 1 are levels of
hBMP-2, hBMP-4 and hBMP-7 and insulin-like growth factor-1 (IGF-1)
|
| Growth Factor |
Level Detected (pg/g of bone) |
| BMP-2 |
8,423 ± 248 |
| BMP-4 |
1,112 ± 19 |
| BMP-7 |
50,581 ± 1,876 |
| IGF-1 |
713 ± 173 |
|
These results illustrate that
OsteoSponge™ provides a host of signaling molecules that are involved in
the remodeling and creation of new bone. Therefore, OsteoSponge™
supports the natural progression of events from bone induction to bone
formation. |
|
