Diabetic Foot Ulcer (DFU) - Current Status: Clinical Trial Phase I/IIa

Background Information

In the course of Diabetes Mellitus, diabetic foot ulcer (DFU) is the most common and severe complication, affecting 15% of diabetic patients in their lifetime (Leone et al., 2012), while Diabetes Mellitus itself is a major health burden in modern society. DFU is associated with a higher morbidity and is 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 caused by DFU (Leone et al., 2012). This estimate is expected to worsen mirroring the increasing population of people affected by diabetes and obesity, assuming that the number of diabetic patients rises from 366 million in 2011 to 552 million by 2030, as forecasted by the International Diabetes Federation (IDF) (IDF’s Diabetes Atlas, 5th edition, 2011).

Due to the regeneration potential of ABCB5-positive (ABCB5+) mesenchymal stem cells (MSCs), based on the anti-inflammatory and pro-angiogenic effect, skin-derived ABCB5+ MSCs are expected to have a regenerative potential when applied to patients e.g. suffering of DFU.

Mesenchymal stem cells/mesenchymal stromal cells (MSCs) have been studied and used for more than a decade now to treat various diseases (Casiraghi, et al., 2013). MSCs are multipotent cells that can replicate as undifferentiated cells and that have the potential to differentiate into adipocytic, chondrocytic, or osteocytic lineages (Pittenger, et al., 1999). In the wound healing field, MSCs applied to chronic wounds lead to improved wound healing and wound closure (Falanga, et al., 2007). Human MSCs are most commonly isolated from the mononuclear fraction of the bone marrow (BM) or from adipose tissue. However, also other tissues contain convincing stem cell compartments. Skin is renown for its high endogenous regenerative potential, which is sustained by self-renewing resident progenitor cell populations found in its various compartments, including the dermis. ABCB5+ dermal cells constitute a subpopulation of cells within the dermal MSC compartment.

The examinations of the laboratory of Prof. Dr. Frank lead to the identification of a distinct subpopulation of ABCB5+ progenitor cells isolated from human skin. To isolate those cells, a specific and sensitive antibody was created (Frank, et al., 2003) and purified under GMP-conditions as well as tested for viral contaminations (TICEBA).

ABCB5+ cells are found in human skin of healthy individuals of all ages, whereas protein levels decrease with increasing age. This finding supports the idea of the involvement of ABCB5 in the regenerative capacity and the ageing process of the skin (Meier, et al., 2010).

TICEBA GmbH has developed a highly standardized process to isolate ABCB5+ from human skin biopsies and to expand and accumulate the precious stem cells in cell culture. In scientific cooperation with University Hospital Ulm, Germany and the University Hospital Würzburg, Germany as well as the Brigham and Women´s Hospital, Boston / USA, RHEACELL GmbH & Co. KG was able to show through a variety of preclinical studies that the application of ABCB5+ on acute and chronic wounds leads to enhanced wound (submitted: Vander Beken et al, 2016).

 

Procedure

You will find informationen on the allogeneic clinical trial with ABCB+ mesenchymal stem cells HERE.

 

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Clinical Trials

We are now also recruiting patients for further clinical studies in phase I/IIa with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells for the following indications: chronic venous ulcer (CVU), diabetic foot ulcer (DFU) and peripheral arterial occlusive disease (PAOD). For more information click HERE.

License

Besides the authorization to manufacture a human medicinal product in accordance with § 13 (1) of the German Medicinal Products Act (AMG) for autologous mesenchymal stem cells, TICEBA is also authorized to manufacture a medicinal product for allogeneic mesenchymal as well as allogeneic limbal ABCB5 + stem cells following a recent extension. For more information click HERE.

The Story of Stem Cells

Review our category "The Story of Stem Cells" with the newest topic "Stem cells in wound healing" HERE.

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