The trial has been approved by the U.S. Food and Drug Administration (FDA) and the other respective competent national regulatory authorities and has recently been granted Orphan Drug Designation for the treatment of RDEB in the EU and the USA.

For the international and FDA approved clinical trial for the limbal stem cell medicinal product LSC2 our daughter company RHEACELL recently received Orphan Drug Designation status in the EU for the treatment of limbal stem cell deficiency (LSCD) and Fast Track Designation in the USA. More information can be found HERE and HERE.

Our subsidiary RHEACELL is recruiting patients for further clinical trials in phase I/IIa with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells for the indications chronic venous ulcers (CVU), diabetic foot ulcers (DFU), peripheral arterial occlusive disease (PAOD), epidermolysis bullosa (EB) and acute on chronic liver failure (ACLF) and with allogeneic ABCB5+ limbal stem cells for the indication limbal stem cell deficiency (LSCD). For more information click HERE.

In a comprehensive preclinical study program, safety and local tolerability of ABCB5+ MSCs following subcutaneous, intramuscular and intravenous application has been demonstrated (Tappenbeck et al., 2019).