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

Comparative, multi-site study demonstrates benefits of BioE’s cord blood processing system for the cord blood banking industry, including ability to obtain greater stem cell yields

May 9, 2007

ST. PAUL, Minn. ¾ May 9, 2007 ¾ 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 and Data

            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.

 

Clinical Study Data

Hetastarch (24)

PrepaCyte-CB (106)

TNC (excluding nRBC)

82.8 ± 7.8

89.5 ± 6.2

MNC (mononuclear cells)

87.1 ± 10.1

88.1 ± 11.8

Stem Cells (CD34+ Marker)

85.3 ± 14.0

88.4 ± 27.1

CFU (colony-forming units)

90.7 ± 37.9

125.3 ± 64.2

RBC Depletion

77.9 ± 8.8

98.5 ± 0.5

           

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.”

Additional PrepaCyte-CB Information

§         PrepaCyte-CB is manufactured in accordance with U.S. Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP) regulations. The system’s interconnected, closed-bag set limits cell manipulation and helps minimize chances of contamination and identification errors.

§         PrepaCyte-CB is intuitive and easy-to-use, facilitating greater overall processing consistency. Furthermore, PrepaCyte-CB only requires a standard laboratory centrifuge to concentrate cells — no additional costly capital equipment is necessary.

§         PrepaCyte-CB is BioE’s first clinical product originating from the patented PrepaCyte technology platform. This flexible platform can produce a variety of cellular products — an important feature as other cell types become clinically relevant.

§         U.S. 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 more detailed PrepaCyte-CB clinical study data and a visual representation of how the PrepaCyte-CB System works, visit www.bioe.com/prepacytecb.

About BioE

            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.