Clinical Study Finds BioE’s PrepaCyte-CB Significantly Improves Cell Recoveries from Cord Blood

BioE^®, Inc., a biomedical company that provides enabling, high-quality human stem cells for drug discovery and therapeutic research, announced today its PrepaCyte^®-CB Umbilical Cord Blood Processing System significantly improves the recovery of therapeutically important total nucleated cells (TNC) and white blood cells (WBC) from human umbilical cord blood when compared to traditional hetastarch-based cord blood processing methods, according to the results of a multi-site, comparative, in-vitro clinical study.

The study also demonstrated PrepaCyte-CB’s ability to remove approximately 99 percent of all unnecessary red blood cells (RBC) from final processed cord blood.

“Our clinical study demonstrates the PrepaCyte-CB System can provide public and private cord blood banks greater yields of clinically relevant cells — including stem cells — from cord blood, while minimizing the risk of contamination during processing,” said Michael Haider, president and chief executive officer (CEO) for BioE. “These benefits are important to cord blood banks as they strive to maximize the yield of therapeutically beneficial cells they cryopreserve. The positive results of this study also mark an important milestone for our company as we prepare the PrepaCyte-CB System for market release this month.”

PrepaCyte-CB is a sterile, three-bag, closed system used to separate and obtain TNC including CD34+ stem cells and other stem cells from cord blood. When mixed with cord blood, the proprietary reagent within PrepaCyte-CB rapidly facilitates a negative selection process causing unwanted cells, such as RBC, to settle to the bottom of the bag — leaving viable cells unmodified and available for easy collection in the upper fraction of the solution.

Study Details
A total of 130 cord blood units were processed during the comparative, multi-site clinical study, including 106 units using the PrepaCyte-CB System. Study results indicate cord bloods processed with PrepaCyte-CB deliver a statistically significant improvement in recoveries of TNC and WBC versus hetastarch-based methods. Additionally, PrepaCyte-CB appreciably improved the percentage of RBC removed from the final product compared to hetastarch.

Delivering Greater Stem Cell Yields
Study participant David McKenna, M.D., assistant professor of Lab Medicine and Pathology and medical director of the Clinical Cell Therapy Lab at the University of Minnesota, describes the potential of the PrepaCyte-CB System.

“This is the first reagent-based system that provides a consistent and easy-to-use method for obtaining significant stem cell yields from human umbilical cords,” said Dr. McKenna. “The processing efficiency that the PrepaCyte-CB system provides could be particularly valuable with low volume units.”

Increasing Clinical Utility of Cord Blood
As research continues to demonstrate the clinical utility of cord blood, the need for better cord blood stem cell separation products is critical for researchers, such as study participant Colin McGuckin, Ph.D., professor of regenerative medicine at Newcastle University’s Centre for Cord Blood at the North East England Stem Cell Institute (NESCI).

“Based on our work with PrepaCyte-CB, this system’s unique ability to minimally manipulate and retain considerable quantities of viable TNC, including stem cells, while removing essentially all RBC is very important,” said Dr. McGuckin. “As a result, processing cord blood with PrepaCyte-CB should facilitate more efficient cord blood banking — for use in an increasing number of blood disorders and medical conditions.”

Bringing Consistency to Cord Blood Processing
“Based on my experience, PrepaCyte-CB is the first cord blood processing product to integrate a separation reagent and cryopreservation-ready, closed-bag system,” said Dwight Brunoehler, president and CEO for study participant Cryobanks International, a public and private cord blood bank. “Because BioE can produce PrepaCyte-CB with lot-to-lot reproducibility, the product can bring consistency between cord blood banks. The findings of the PrepaCyte-CB comparative study should garner the attention of the cord blood banking industry, which is continually looking to reliably and cost-effectively obtain high-quality cellular material from cord blood.”