A device for use in a clinical laboratory setting or intraoperatively for preparation of a cell concentrate from bone marrow has been authorized by the U.S. Food and Drug Administration. The device, MarrowXpress (MXP) (pictured), is a derivative of ThermoGenesis Corporation’s AutoXpress™ (AXP™) Platform that is used to volume reduce and collect stem cells from umbilical cord blood.
Bone marrow-derived stem cells are the dominant source of stem cells studied in regenerative medicine clinical trials for treating several large patient population diseases and injuries including blood disorders, ischemic heart diseases, peripheral artery diseases, and diabetes. According to the latest U.S. Centers for Disease Control and Prevention statistics, there are 24 million people in the U.S. with heart disease, 16.2 million with peripheral artery disease, and 15.8 million with diabetes. Worldwide statistics would be more than twice these amounts.
In addition, bone marrow stem cells are currently processed in a number of orthopedic and vascular surgeries inside and outside the U.S. Outside the U.S., stem cell treatments for ischemic heart disease are practiced and reimbursed by insurance companies.
“We are confident that the users of this technology will value the unique capability of this device to achieve significantly improved recovery of the stem cells from bone marrow meaning that less marrow will need to be collected from their patients to obtain the same number of stem cells,” said Dr. John Chapman, Vice President of Research and Development and Scientific Affairs.
“While the initial marketing application for the MXP will be for bone marrow processing, both at
point-of-care and in a laboratory, we will continue our exploration of the use of this technology platform for other sources of adult stem cells including mobilized peripheral blood and adipose tissue stem cell processing,” Chapman added.
Illustration: Thermogenesis Corporation.
Thermogenesis Corporation (07/14/08)