Chronic Venous Ulcer (CVU) - autologous

The recruitment process for patients with the indication chronic venous ulcer (CVU) for the clinical trial in phase 1/2a started now.

Heidelberg, April 2016 - The aim of the multicentric clinical trial is to investigate the compatibility of ABCB5-positive (ABCB5+) cells in the human body, as well as its efficacy in patients with CVU. As endpoints of the trial, the percentage reduction in wound size and the occurrence of adverse reactions have been defined. 37 patients are recruited for the trial in Germany. Therefore, we use the patent from Brigham and Women´s Hospital, Boston / USA and the Children's Hospital, Boston / USA. Scientific partners are Harvard Medical School, Boston / USA, Prof. M. Frank. Clinical partners are  The University of Ulm, Germany, Department of Dermatology and Allergology and the University Hospital Würzburg, Germany, Department of General and Visceral Surgery, Vascular and Pediatric Surgery and Department of Dermatology, Venereology and Allergology.

Find more information HERE (ClinicalTrials.gov) or HERE (EU Clinical Trials Register).

Background information on the study can be found HERE.

 

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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.

Clinical Trial

Together with our subsidiary RHEACELL we are recruiting patients with the indication chronic venous ulcer (CVU) for the clinical trial in phase 1/2a. 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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