BioE Submits 510(K) Application to FDA for Umbilical Cord Blood Processing System
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BioE®, Inc., has announced 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.
“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,” Buchert added.
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.
“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.
