Albumin is a bone protein. Osteoblasts generate albumin first and then collagen. Albumin is a standard constituent of stem cell growth media. We have modified the well-known and safely used human allograft processing protocol by adding a patented serum albumin impregnation step to the procedure. This way the healing power of serum can be harnessed in bone grafting, simply by using BoneAlbumin™. Since both components, albumin and bone are safely used for decades, there is very little chance of unknown adverse effects. Each of our grafts is processed in licensed bone banks under protocols approved by the competent authorities. Close to 3,000 implantations have been performed since 2011 without any major complication. BoneAlbumin™ is currently marketed as a bone void filler in dentistry and orthopedics, supported by peer-reviewed scientific publications.
In dentistry, bone augmentation is a common procedure to support the bone stock before implantation. BoneAlbumin™ is used in the form of fine bone chips for sinus lift or extraction socket preservation, or as blocks to repair larger defects. Several clinical studies have demonstrated the superiority of human bone grafts over animal or synthetic bone fillers in these indications. Indeed, in the United States the most common dental bone fillers are of human origin and they are gaining traction in Europe as well. Our technology takes allografts to an even higher level of biological activity, essentially integrating serum albumin in order to kick-start the regeneration provided by stem cell from the surrounding bone marrow. This way both time and cost are saved since in order to reach superior efficacy no further plasma device or cell harvesting is needed to provide the necessary growth factors.
In orthopedics, the main indication is revision arthroplasty during which the extent of bone loss requires grafting in order to support revision prosthesis, typically in the hip and the knee. Best surgical results were achieved by building up the tibia plateau with large structural grafts, or with impaction grafting of BoneAlbumin™ chips into the acetabulum. BoneAlbumin™ was successfully used even in very complex cases where both proximal femur and acetabulum had to be replaced by large structural grafts, custom-made for the patient and fine-tuned by the surgeons in the operation room. In one case even a re-revision became necessary during which the 1.5-year old tibia graft was so well incorporated and bleeding that it was left intact and could support a new implant.
There is an alphabet soup of blood derivatives out there, such as L-PRP, P-PRP, PPP, ACS, PRGF, and so on – each touted as being enriched in selected factors. However, research shows that the cells do not need an overdose of any factors, they need just the right ones in the right concentration. This physiological composition can create optimal results. Hyperacute serum is just that: the activated serum from the earliest phase of the healing cascade which has the highest proliferation supporting capacity without altering the lineage-determination of the cells. Hyperacute serum can be used in an autologous manner, i.e. harvested from the patient who is then receiving hypACT™ in the same medical procedure. For example, 18 ml blood is drawn in a routine way, then centrifuged, and processed to obtain hypACT™ which is transferred to a syringe. It is then reapplied in any way the physician sees fit, i.e. as an intraarticular injection in the knee. OrthoSera has developed a device which makes it easy and safe to isolate, process, and reapply hypACT™ in a closed system at the bedside. The device is CE marked and available for clinical use in Europe.