University of California, Davis (UC Davis) Vascular Center (Sacramento) researchers have embarked on an FDA-approved study that uses a patient’s own stem cells to increase blood circulation to the lower leg with the hope of preventing amputation due to severe arterial disease or diabetes.
“Losing a limb is a devastating complication of advanced vascular disease,” John Laird, MD, professor of medicine and medical director of the Vascular Center and a principal investigator of the study, said in a UC Davis press release. “Many patients require limb amputation because angioplasty or surgery is either not successful or not possible. Stem cell therapies could provide less-invasive options for these…patients and may offer a more permanent way to restore circulation.”
The study involves a one- to two-hour surgical procedure during which bone marrow is harvested from the pelvis and spun in a centrifuge to separate mononuclear cells. These cells consist of white blood cells and mononuclear stem cells containing concentrations of endothelial progenitor cells-the stem cells responsible for initially forming blood vessels in utero. The separated stem cells are injected at multiple points into the muscle of the leg at risk for amputation.
“The hope is that what these cells do in the very early stages of life can be repeated much later in life by producing new blood vessels that circumvent damaged ones altogether,” Laird said.
The entire process requires a single operating room procedure and involves minimal discomfort, according to the University statement. Patients remain in the hospital overnight and are expected to return to the UC Davis Vascular Center for a series of five follow-up visits over the course of a year.
The trial sponsor, Biomet Biologics of Warsaw, Indiana, manufactures the specialized equipment-called MarrowStim™-that is used to extract blood cells from the bone marrow along with the high-speed, table-top centrifuge. The company recently completed a Phase I safety study of the technology, and the results were used to refine the technology and launch the trial.
The study initiates the stem cell research program of the Vascular Center, which is currently the only West Coast site for this investigation. UC Davis was selected to participate because of its vascular and bone-marrow harvest expertise in addition to the resources of its Institute for Regenerative Cures.
“Our own research in mice has shown that adult human stem cells are very efficient at targeting areas of low oxygen and promoting the formation of new blood vessels,” Jan Nolta, PhD, director of the UC Davis School of Medicine Stem Cell Program and the Institute for Regenerative Cures, said. “This next stage of our research will determine if the treatment truly offers hope for people without other options and who are at risk of losing a limb.”
Laird and Nolta planned the study with a team of surgeons, researchers, nurses, and lab specialists from the Institute for Regenerative Cures and UC Davis Medical Center.
Editor’s note: This story has been adapted from materials provided by the University of California, Davis Vascular Center, Sacramento.
