The Trinity ELITE allograft, as discussed in my previous blog, is a cryopreserved cellular bone graft that contains living mesenchymal stem cells, or MSC’s, and osteoprogenitor cells, commonly referred to as OPC’s. Additionally, TE also contains extended particles of demineralized cortical bone, which combine to provide the graft with cohesiveness and moldability.

Both the MSC’s and OPC’s within the Trinity ELITE’s structure have shown that they are capable of developing and separating into bone-forming cells after having thawed, then culturing the cryopreserved tissue. As an added bonus, these cells have also been known to release trophic factors linked to the healing of bones, thus proving their worth as determinants in bone regenerations.

To ensure the Trinity ELITE’s effectiveness, a quality control procedure is conducted evaluating cell viability. This test begins immediately after processing and frozen storage in order to guarantee successful cryopreservation, and proper maintenance of cell health. The standards of this viability are determined by a quantitative metabolic test providing an accurate measure of cellular activity. The results of the TE’s viability were compared to those of Osteocel Plus, another cryopreserved bone graft that contains living cells, which is also commercially available.

Both tissue forms of the Trinity ELITE and Osteocel Plus were stored at their recommended storage temperatures until testing to ensure accuracy, which were then thawed at 98.6 degrees fahrenheit until their elements were free-flowing. Viability was then measured by levels of cell activity through the aforementioned quantitative metabolic testing, following an opening and rinsing of the cryoprotectant solutions from each sample.

Over the course of 7 months, data was collected from the quality control record of 200 consecutive Trinity ELITE tissue lots to determine the product’s immediate post-thaw viability. The average that was recorded was then compared to the average viability of 8 lots of Osteocel Plus, with standard error being calculated for each condition. In comparison to the 8 lots, TE’s cell viability was recorded as being substantially greater than that of Osteocel Plus following immediate post-thawing.

Among the 200 lots of Trinity ELITE, the average cellular activity was nearly four times higher than Osteocel Plus cellular activity. Even after conducting tests simulating the environment of an operating room by testing two hours after being thawed, TE still had much higher levels in both activity and stability. After those two hours, Osteocel Plus recorded a 41.3% decrease in cellular activity compared to a meer 18.4% decrease in TE’s.

 
In conclusion, Trinity ELITE’s cellular activity was proven to be much higher than the activity of Osteocel Plus cells. Considering the fact that metabolic activity levels are directly proportionate to the number of living cells within the tissue, this research also determines viability. It is important to note however, that these results may vary depending on donor selection, the formation of tissue, methods of processing, and storage conditions. All of these factors were taken into account upon testing both products, and the significant difference in TE’s cellular viability compared to the viability of Osteocel Plus cells were substantial enough to declare the Trinity ELITE as the bone graft that can best provide osteoconductive, osteoinductive, and osteogenic elements.