ACTIGEN Verified Inductive Bone Matrix and Autologous Blood by CellRight Technologies
Background
CellRight Technologies® has developed ACTIGEN™ Verified Inductive Bone Matrix, a dehydrated, verified inductive matrix that may be hydrated with saline, blood, Bone Marrow Aspirate (BMA), Platelet Rich Plasma (PRP), or other cellular components in accordance with a physician’s well-informed medical judgment. The clinician may add allograft or autograft to ACTIGEN™ Verified Inductive Bone Matrix and hydrate the grafting material to the desired consistency. ACTIGEN™ Verified Inductive Bone Matrix does not contain any extrinsic carriers and is entirely derived from 100% human allograft bone. ACTIGEN™ Verified Inductive Bone Matrix resists irrigation and has a shelf-life of 5 years from the date of internal packaging. CellRight Technologies® uses a proprietary demineralization process designed to preserve native BMP’s, as demonstrated in their osteoinductive testing. Every lot of ACTIGEN™ Verified Inductive Bone Matrix is verified for osteoinductivity post sterilization as a condition for distribution. In-vivo test results have histologically demonstrated the presence of all 5 bone-forming elements (Chondrocytes, Osteocytes, Bone Marrow Cells, Cartilage, and New Bone). ACTIGEN™ Verified Inductive Bone Matrix has also been in-vitro lot tested for the endogenous BMP-2 test marker for osteoinductivity. Studies show that BMP’s irreversibly induce differentiation of perivascular mesenchymal-type cells into osteoprogenitor cells.
It is well documented that not all DBM’s are created equal. How a DBM is processed and formulated have the biggest effects on its potential efficacy (1). There is a positive association between greater % DBM-base (bone powder) in the DBM-base product and higher fusion rate (2). Moreover, it doesn’t matter how great your cell is, if you don’t deliver it with the right matrix with appropriate cell-friendly
characteristics, cells will not likely survive after implantation (3).
A 5cc sample of ACTIGEN™ Verified Inductive Bone Matrix was provided to a well known U.S. cell-concentration device manufacturer for the purpose of rehydrating ACTIGEN™ Verified Inductive Bone Matrix with a fluid rich in growth factors (GFC) and mesenchymal stem cells (MSC’s). The study was designed to measure percent cell viability over one (1) hour as a worse case scenario. Current clinical practice is to implant the patient’s concentrated stem cells back into the patient as quickly as possible in an effort to maintain cell viability.