Highest Recovery of Cord Blood Stem Cells Achieved with New
Automated Processing System, Study Shows
Data Highlighting Industry-Leading Technology Adopted by Cord Blood Registry(r) Presented at American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting
SAN DIEGO, May 8 /PRNewswire/ -- A validation study presented today at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting indicated that new automation technology for cord blood stem cell processing, the AutoXpressTM Platform (AXPTM), achieved a
99.3 percent recovery rate of the mononuclear cells (MNCs) in the cord blood collections tested. This is a 22.7 percent higher yield than the commonly-used Hespan-based cord blood stem cell processing method, which achieved an MNC recovery rate of 80.9 percent in the largest published Hespan study, Cord Blood Transplantation (COBLT).
"Cell yield is an important measure of a cord blood collection's transplant utility and stem cells are contained in the MNC population," said Dr. David Harris, Ph.D., professor of immunology at the University of Arizona; scientific director for Cord Blood Registry; and lead investigator of the study. "Research studies have correlated transplant survival rates and improved outcomes with the number of stem cells used in therapy."
AXP, developed by ThermoGenesis and distributed by GE Healthcare, is a functionally-closed, automated technology for cord blood stem cell processing. Cord Blood Registry (CBR) is the first and only family cord blood bank to adopt AXP and use this state-of-the-art technology to prepare a newborn's genetically-unique cord blood stem cells for cryopreservation and storage until they may be needed for future therapeutic use within the family. The largest public donation bank, The New York Blood Center, has also adopted AXP processing.
Separation and recovery of the stem-cell-rich MNC population is a critical step in cord blood processing. The Hespan method relies on an additive to facilitate separation of cord blood into layers of its components: plasma; red blood cells; and the MNC population of white blood cells and stem cells. The MNCs are then collected by a laboratory technician.
Replacing the need for additives and human manipulation, AXP uses optical sensor technology during the centrifuge process to achieve precision separation and retention of nearly all of the target MNC population. By automating the cell separation process, AXP ensures a low risk of contamination and predictable reliability of results collection-to-collection.
CBR started phasing AXP processing into its operations in December 2006 and is currently processing about 3,000 units per month with the system. Full production phase-over to AXP is expected to be complete by September 2007.
ThermoGenesis initiated an FDA Device Master File for AXP in October 2005 and submitted a 510(k) pre-market notification application in February of this year.
Validation Study Details
In phase I of a multi-phase study, thirty-one cord blood collections were processed using AXP to test the limits of the system. These collections were then compared to the 8,730 collections processed with Hespan for COBLT, the largest published Hespan study. Studies for both methods obtained pre- and post-processing MNC counts using automated cell counting and were used to compare the absolute and percent MNC recovery of each system. The next phase of AXP testing, which is analyzing more than 1400 collections and is the largest AXP processing study to date, will be submitted for future publication.
About Cord Blood Stem Cells
The blood remaining in an umbilical cord immediately after birth is a rich source of cord blood stem cells that can be collected easily and painlessly without risk to the newborn or mother. Cord blood stem cells are increasingly being used to improve and save lives, and have been used in more than 8,000 transplants worldwide. Today, they are used successfully to treat a wide range of blood diseases, genetic and metabolic disorders, immunodeficiencies and certain forms of cancer. A number of medical research studies have demonstrated that cord blood stem cells are able to differentiate into multiple cell types and may have potential use in regenerative medical therapies, such as treating Type 1 diabetes, cardiac disease and several neurological disorders.
About Cord Blood Registry
Cord Blood Registry (CBR), a registered trademark of Cbr Systems, Inc., is the largest cord blood stem cell processing and cryopreservation service for familial use in transplantation and regenerative medicine and the most recommended cord blood bank by obstetricians. Accredited by AABB, Cord Blood Registry preserves cord blood stem cells for more than 175,000 newborns throughout the world. CBR has released more than 45 client cord blood collections for specific therapeutic use, more than any other family cord blood bank. The company's research and development is focused on advancing collection, processing, and storage methods to optimize quality and cell yield. Additionally, CBR processes and stores donated collections that are available for research programs worldwide focused on stem cell expansion and other cell-based therapies. For more information about CBR, visit www.CordBlood.com.
About ThermoGenesis
ThermoGenesis Corp. (NASDAQ: KOOL) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. GE Healthcare is ThermoGenesis' exclusive global distribution partner for AXP. For more information, visit www.Thermogenesis.com.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. The company's vision is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit www.gehealthcare.com.
ThermoGenesis©,Autoxpress™ , and AXP™ are registered trademarks of ThermoGenisis Corp., Sepax is a registered trademark of Biosafe SA. Viacord is a registered trademark of ViaCell,Inc
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