BioE Submits 510(k) Application to FDA for Umbilical Cord Blood Processing System
Pre-market notification supported by clinical data demonstrating PrepaCyte-CB Processing System’s ability to obtain therapeutically beneficial TNCs and stem cells from cord blood
ST. PAUL, Minn.--(BUSINESS WIRE)--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.
“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.”
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 www.bioe.com/prepacytecb.
Headquartered in St. Paul, Minn., BioE is a biomedical company that provides enabling, high-quality human stem cells for drug discovery and therapeutic research. The company’s novel Multi-Lineage Progenitor Cell™ (MLPC™) stem cell — derived from human umbilical cord blood and isolated using PrepaCyte®, the company’s proprietary cell separation platform — provides clinicians and researchers a flexible, long-term and non-controversial tool for therapeutic research and drug discovery and screening. BioE is privately owned and was founded in 1993. For more information about the company, please visit www.bioe.com or call (800) 350-6466.