The Vitalgenics reGeneis Stem Cell program utilizes a revolutionary new processing system, branded as PREMIERMAX®, which significantly reduces red cell contamination in the transplant product while recovering an equal or higher number of stem cells (when compared to other automated and traditional methods). PREMIERMAX® also reduces the level of DMSO required to adequately preserve the cells during the freezing process, thereby reducing potential recipient exposure to this sometimes toxic cryoprotectant.

PREMIERMAX® uses 2 unique reagents combined with individual unit Quality Control by highly trained technicians, to produce a superior final transplantation product. The processing reagent is PrepaCyte®-CB, which demonstrates an unrivaled ability to remove red blood cells over any other method on the market today. Red cell reduction reduces the amount of free hemoglobin in the thawed product infused to the recipient, thereby increasing the safety of the infused product. Additionally, PrepaCyte®-CB has shown in clinical trial and independent evaluation to increase the final stem cell population recovered, most significantly in the post-thaw colony forming assay which indicates functionality of the stem cells for engraftment.

The second key reagent in PREMIERMAX® is the freeze media, CryoStor® CS10. CryoStor is specifically designed to protect cells at ultra-low temperatures , unlike traditional cryopreservation reagents. This results in improved cellular transition through phase change from a liquid blood product to the frozen state for long-term storage, and again during thawing prior to infusion. During our validation of CryoStor® CS10, it was demonstrated that a less concentrated amount of the cryoprotectant reagent DMSO could be used in the freezing process while maintaining acceptable cellular functionality post-thaw.

The most important aspect of any change in status quo is the resulting effect of the change. Historically, the lower stem cell dose of a CBSC product when compared to a bone marrow or peripheral blood stem cell collection resulted in a longer time for bone marrow reconstitution (or engraftment). This led to early beliefs that CBSC could only be useful for pediatric patients or small adults. It was also realized that CBSC would typically result in longer periods of non-immunity, resulting in longer hospital stays for the recipient, even though GvHD is typically reduced.

A team of scientists from the Cell Therapy Research Institute and the Newcastle Centre for Cord Blood published two separate studies that reached the same conclusion – our process is superior to hetastarch.

Simply put, the unbiased research team from the Cell Therapy Research Institute and the Newcastle Centre for Cord Blood also concluded that our process “is consistently the best performer over the whole range of analysis.” It provides the most efficient recovery, the highest red cell depletion, and reduces the risk for contamination.

Just like you, we wanted to know which process was the best. Having been in the industry since 1995, we have seen cord blood banking come a long way since the days of hetastarch, a first generation method. Over years of processing both public and private cord blood collections, we learned what worked best. We looked into clinical research that asked the same question. We found our answer in the US National Library of Medicine of the National Institute for Health.