A validation study presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting indicated that new automation technology for cord blood stem cell processing, the AutoXpress™ Platform (AXP™), 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."
Cord Blood Registry (CBR) is said to be the first and only family cord blood bank to adopt AXP and use this 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.