The current news is therefore encouraging: In a regulatory agency-approved Phase IIa clinical study, RHEACELL, a company specializing in stem cell therapies, was able to accrue safety and initial efficacy data for ABCB5-positive mesenchymal stem cells (ABCB5+ MSCs) in the treatment of CVU.
This study demonstrated successfully that topically applied, highly purified ABCB5+ MSCs modulated the patient’s immune system to promote wound healing. In approximately 70 percent of patients, chronic venous ulcers decreased on average by 82 percent in size and even complete wound closures were observed.
The starting material for generating ABCB5+ MSCs in high numbers is allogeneic human donor skin. These stem cells are manufactured by TICEBA GmbH, Heidelberg, in a patented process. Using this method, highly purified stem cells can be manufactured in large numbers, reliably isolated and finally produced as a highly purified, homogeneous drug substance [highly functional manufactured stem cells (H.F.M stem cells)]. These ABCB5+ MSCSs are classified by the European Medicines Agency (EMA) as an Advanced Therapy Medicinal Product (ATMP) which is manufactured under good manufacturing practice (GMP) in accordance with §13 paragraph 1 of the German Medicinal Products Act (AMG).
This multicenter clinical trial was conducted in Germany. Following demonstration of efficacy and safety of the ATMP, the data obtained will be used for further clinical development of the drug. The next phase clinical trial development is currently in preparation.
This study demonstrated successfully that topically applied, highly purified ABCB5+ MSCs modulated the patient’s immune system to promote wound healing. In approximately 70 percent of patients, chronic venous ulcers decreased on average by 82 percent in size and even complete wound closures were observed.
The starting material for generating ABCB5+ MSCs in high numbers is allogeneic human donor skin. These stem cells are manufactured by TICEBA GmbH, Heidelberg, in a patented process. Using this method, highly purified stem cells can be manufactured in large numbers, reliably isolated and finally produced as a highly purified, homogeneous drug substance [highly functional manufactured stem cells (H.F.M stem cells)]. These ABCB5+ MSCSs are classified by the European Medicines Agency (EMA) as an Advanced Therapy Medicinal Product (ATMP) which is manufactured under good manufacturing practice (GMP) in accordance with §13 paragraph 1 of the German Medicinal Products Act (AMG).
This multicenter clinical trial was conducted in Germany. Following demonstration of efficacy and safety of the ATMP, the data obtained will be used for further clinical development of the drug. The next phase clinical trial development is currently in preparation.
