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Chronic Venous Ulcers (CVU)
Clinical Trial Phase I/IIa

Background Information

Chronic venous ulcers (CVUs) develop as a consequence of impaired venous drainage of the lower extremities, mainly due to venous reflux or venous outflow obstruction. The increased venous pressure causes micro-circulatory disturbances, initiating a cascade of pathophysiological events that lead to tissue breakdown and the development of painful wounds. To date there is no conclusive evidence that any particular dressing, topical agent or systemic agent can effectively improve venous ulcer healing. For severely affected patients, surgical interventions aiming at eliminating the cause of the venous hypertension are often the last hope.


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 CVU.


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).


Process

Here you can find more information about the clinical trials with autologous and allogeneic ABCB5+ MSCs.


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