BioE Submits 510(K) Application to FDA for Umbilical Cord Blood Processing System

BioE^®, Inc., a biomedical company that provides enabling, high-quality human stem cells for drug discovery and therapeutic research, announced today it submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory and marketing clearance for its PrepaCyte^®-CB Processing System for umbilical cord blood.

PrepaCyte-CB is a sterile, three-bag, closed cell processing system used to separate and collect therapeutically important cells, including stem cells, from human umbilical cord blood. When mixed with cord blood, the proprietary reagent within PrepaCyte-CB rapidly facilitates a negative selection process. This process causes essentially all red blood cells (RBCs) to settle to the bottom of the mixture, leaving significant quantities of viable and unmodified cells - including high yields of total nucleated cells (TNCs) and stem cells - in the upper fraction of the solution. Public and private cord blood banks can easily collect these viable cells for cryopreservation and eventual transplantation in humans.

“The submission of our PrepaCyte-CB 510(k) application marks an important milestone for us as we progress toward providing public and private cord blood banks with a product that allows them to process and store higher-quality cord blood units,” said Carol Buchert, MT(ASCP), vice president of operations and regulatory affairs for BioE. “Our 510(k) application is supported by clinical studies demonstrating PrepaCyte-CB’s ability to more effectively and efficiently separate therapeutically viable cells from human umbilical cord blood.”

Specifically, according to the results of a multi-site, comparative, in-vitro clinical study, PrepaCyte-CB significantly improves the recovery of TNCs and white blood cells (WBCs) from human umbilical cord blood when compared to a traditional hetastarch-based cord blood processing method currently utilized by many cord blood banks. Stem cells make up a portion of the total TNC recovery. The study also demonstrated PrepaCyte-CB’s ability to remove approximately 99 percent of all unnecessary RBCs from the final processed cord blood unit. Additionally, using PrepaCyte-CB to process cord blood returns more stem cells with hematopoietic reconstitution (blood-forming) potential versus hetastarch.

In a separate study, research results show that processing cord blood with PrepaCyte-CB generates significant time-savings versus hetastarch-based methods. Furthermore, observations from early animal studies indicate that cells processed with PrepaCyte-CB potentially deliver greater long-term engraftment rates when compared to hetastarch-based methods.

“We anticipate PrepaCyte-CB and its unique cell processing capabilities will offer an attractive option to cord blood banks as they consider upgrading their cord blood processing techniques and protocols,” Buchert added.

PrepaCyte-CB is manufactured under FDA current Good Manufacturing Practices (cGMP) and is currently available for clinical use in U.S.-based cord blood banks under an Investigational New Drug (IND) application. United States Patents 7,160,723 and 6,933,148 protect the cell separation methods and compositions used in the PrepaCyte-CB system; other related patents are pending.

For additional information, clinical study data and a visual representation of how the PrepaCyte-CB System works, visit the article webpage.