Researchers have launched a clinical trial to determine the safety and efficacy of a device that could change the way bone fractures are treated.
The novel device has the ability to quickly concentrate and extract cells from the irrigation fluid used during orthopedic surgery, the University of California, Davis reported.
"People come to me after suffering for six months or more with a non-healing bone fracture, often after multiple surgeries, infections and hospitalizations," said Mark Lee, associate professor of orthopedic surgery, who is principal investigator on the clinical trial. "Stem cell therapy for these patients can be miraculous, and it is exciting to explore an important new way to improve on its delivery."
In the past, stem cells have been used to treat non-healing bone fractures, but obtaining these early cells (which ideally are taken from the patient's own bone marrow) has been challenging. Surgery to extract these cells can be extremely painful, and they must be isolated from bone marrow for an extended period of time.
This new extraction method concentrates the "wastewater" using of a reamer-irrigator-aspirator (RIA) system to enlarge a patient's femur or tibia through high speed drilling. The RIA system filter captures the patient's own bone and bone marrow to be used in a healing bone graft or fusion; these cells could effectively grow new blood vessels and signal wound-healing responses. The device is about the size of a household coffee maker and could be easily incorporated into an operating room.
"The device's small size and rapid capabilities allow autologous stem cell transplantation to take place during a single operation in the operating room rather than requiring two procedures separated over a period of weeks," Lee said. "This is a dramatic difference that promises to make a real impact on wound healing and patient recovery."
