Once it was isolated, it was spliced and then recombined into the DNA of a commonly used mammalian cell, called a production cell. The process began by first identifying and isolating the specific gene that carries the code for making bone morphogenetic protein-2. PHASE 1: IDENTIFYING, REPLICATING, AND STORING THE HUMAN GENE FOR BMP-2 This tightly controlled process of manufacturing rhBMP-2 ensures consistency and sterility of pure solutions of BMP. This protein is a replication of bone morphogenetic protein-2 (BMP-2), which occurs naturally in humans and is important in healing and regenerating bone. The key element to Infuse bone graft is rhBMP-2 which is manufactured using well-established molecular biology techniques. The rate of bone formation, the amount of bone formed, and the density of the resulting bone are positively correlated with both the concentration of rhBMP-2 and the length of time that rhBMP-2 is present at the implant site. The ability of rhBMP-2 to induce new bone formation depends on its concentration. Pre-clinical studies support that the bone formation started by rhBMP-2/ACS is self-limiting, forming a predictable amount of bone at the site of implantation. The bone formation process develops from the outside of the rhBMP-2/ACS implant towards the center until the entire implant is replaced by trabecular bone. Blood vessel formation (angiogenesis) is observed at the same time. Step 5: Bone formationĪs the sponge degrades or dissolves, these stem cells differentiate into osteoblast and begin to form trabecular bone and/or cartilage. The researchers concluded that BMP-2, BMP-6, and BMP-9 may be the most potent agents to induce osteoblast lineage-specific differentiation of mesenchymal stem cells. Alkaline phosphatase activity - a measure of the amount of new bone formation - was significantly increased in all three cell lines by BMP-2, BMP-6, and BMP-9. 20 Three cell lines, representing the different stages of osteoblast differentiation, were each tested. 3-19Ī 2003 in-vitro study compared the bone-forming activity of 14 recombinant human bone morphogenetic proteins. ![]() 1 Pre-clinical studies have shown that rhBMP-2 can cause the differentiation of precursor cells into osteoblasts. 2, 7 In-vitro studies of rhBMP-2 support the fact that differentiation of mesenchymal stem cells into bone-forming osteoblasts plays an essential role in the induction of new bone. 3-7 Step 4: Differentiationīinding to specific receptors on the surface of the MSC, rhBMP-2 causes them to differentiate into bone-forming cells. ![]() In-vitro studies have shown that rhBMP-2 can increase the proliferation of several multipotent cell lines, which can differentiate into osteoblasts, or bone-forming cells. The mesenchymal stem cells around the rhBMP-2/ACS implant increase in number. Mesenchymal stem cells (MSC) move from bleeding bone, muscle, and the periosteum to infiltrate the implant. This cell migration stimulated by a chemical response is called chemotaxis. Step 2: Chemotaxisīone-forming cells migrate to the area of the rhBMP-2/ACS implant. Only when they're used together do they initiate the bone induction process. Neither the rhBMP-2 nor the ACS can produce new bone tissue independently. When rhBMP-2 is placed on an ACS and implanted in the body, it produces new bone tissue at the site of implantation.
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