Diabetic Foot Ulcers (DFU)
Clinical Trial Phase I/IIa
During the course of diabetes mellitus, diabetic foot ulcers (DFU) represent the most common and severe complication, affecting 15 % of diabetic patients in their lifetime (Leone et al., 2012). DFU are the major cause of hospitalization of diabetic patients (Snyder et al., 2009). It is estimated that approximately 50-70 % of total lower limb amputations are due to DFU (Leone et al., 2012). This estimate is expected to increase further, mirroring the increasing number of people affected by diabetes and obesity, assuming that the number of diabetic patients will rise from 463 million in 2019 to 700 million by 2045, as predicted by the International Diabetes Federation (IDF) (IDF Diabetes Atlas, 9th edition, 2019).
Based on their anti-inflammatory and pro-angiogenic properties, ABCB5-positive (ABCB5+) mesenchymal stem cells (MSCs) exhibit a strong regeneration potential. In several experimental models of acute and chronic cutaneous wound healing, ABCB5+ MSCs have been shown to play a significant role in angiogenesis and neo-vascularization (Vander Beken et al., submitted). Thus, administration of ABCB5+ MSCs is expected to improve wound healing in patients with DFU.
In scientific collaboration with the University Clinic of Ulm (Prof. Dr. Karin Scharffetter-Kochanek), the Boston Children’s Hospital (Markus Frank, MD), the Havard Stem Cell Institute (George F. Murphy, MD) and the Brigham and Womens‘ Hospital, Boston (Dennis Orgill, MD, PhD), RHEACELL could show in several preclinical studies that the high-purity ABCB5+ MSCs can contribute to improved wound healing. In models of acute and chronic cutaneous wounds, application of ABCB5+ MSCs accelerated wound healing and improved scar tissue quality (Vander Beken et al., 2019).
HERE you can find more information about the clinical trial with allogeneic ABCB5+ MSCs.