The UC Davis Health System research team that is working to speed therapies to people suffering from critical limb ischemia (CLI) recently returned from visiting its collaborative partners in Spain.
The collaboration between UC Davis and researchers in Cordoba began last year following an agreement between Spain’s Andalusian Initiative for Advanced Therapies and the California Institute for Regenerative Medicine (CIRM). It complements a $14.1 million CIRM grant to John Laird, professor of cardiovascular medicine and director of the UC Davis Vascular Center and Jan Nolta, director of the UC Davis Institute for Regenerative Cures, who are the co-principal investigators on a research project that includes human clinical trials for CLI in 2015.
The research effort involves using bioengineered mesenchymal stem cells to produce a revascularizing factor to restore blood flow and avoid the possible amputation that patients often face when they suffer from the devastating disease impacts of CLI. For the UC Davis study, cells will be injected into the legs of CLI patients to migrate to low-oxygen areas in the patient's diseased limbs.
The five-person delegation, led by Laird, met with their research partners at the University Hospital Reina Sofia in Cordoba, where they visited the Maimonides Institute for Biomedical Research Córdoba and held meetings with teams of cardiovascular surgery, radiology and vascular cell therapy experts. The two teams are working in parallel on a phase I clinical trial of stem cell and gene therapy for CLI, in which genetically modified mesenchymal stem cells will be used to restore blood flow to the feet and legs of diabetic patients.
"Thanks to the collaborative work between the two centers it will be possible to compare the same therapy administered in two different ways,” said UC Davis researcher Fernando Fierro during an interview with the Córdoba Journal, the local Spanish newspaper that covered the group’s visit. “In California, it will be done intra-muscularly. In Cordoba, it will be done intra-arterially, so that way we can analyze which of the two stem cell routes are safer and show more effectiveness."
CLI is caused by severe artery obstructions, which result in a critical reduction in blood flow to the feet and legs. It occurs most commonly in individuals with diabetes and severe peripheral artery disease, and affects about 2 million people around the U.S. The condition is associated with pain, debilitating foot ulcers, gangrene, and an increased risk of leg amputation and death.
In addition to Laird and Fierro, other members of the visiting UC Davis delegation were Christy Pifer, the study’s clinical project manager; Geralyn Annett, scientific project manager; and vascular surgeon Nasim Hedayati, who serves as clinical co-investigator
For more information on this upcoming study and ongoing stem cell studies for critical limb ischemia, please contact Christy Pifer at 916-734-4156.