Dongkoo Bio & Pharma said it would conduct a clinical trial to expand the treatment scope of “Smart X,” an autologous stem cell therapy developed by the company.
The study will evaluate the efficacy and safety of autologous stromal vascular fractions (SVF) in patients with diabetic foot ulcers. The trial will take place at the Catholic University of Korea Seoul St. Mary's Hospital and Keimyung University Dongsan Medical Center.
Diabetic foot ulcer develops in diabetic patients whose foot is affected by ulceration due to neuropathy and changes in blood vessels. After a slight injury or light pressure on a foot, the wound becomes a chronic foot ulcer.
About 15 percent of diabetic patients suffer foot ulcers at least once during their lifetime. Those in a severe case have to receive limb amputation.
Treatments for diabetic foot ulcers include tissue removal, dressing, and administration of antibiotics. In the upcoming trial, researchers will inject autologous SVF cells, in addition to conventional treatments.
“We hope to win approval for a new medical technology using Smart X and provide a fundamental cure for 600,000 local patients with diabetic foot ulcers,” an official at Dongkoo Bio & Pharma said. “We also plan to conduct the study in a hospital affiliated with Southeast University in China.”