Accreditation of Biological Bandages for Burns and Wounds

In January of 2022, SwissMedic has officially authorized the investigational use of the first generation of Progenitor Biological Bandages (PBB) in a two-arm prospective and observational clinical trial. Applied and translational research on PBBs began over 25 years ago in the Lausanne University Hospital (CHUV) Burn Center and continued notably with the Conference of Swiss Universities in a CRUS project within the CABMM, led by Prof. Applegate and Prof. Raffoul of the CHUV.

Clinical trials centered on allogeneic progenitor cytotherapies for cutaneous affections have been on-going in the CHUV since 2000, with several prestigious publications documenting the clinical progress in this field within the Swiss progenitor cell transplantation program (e.g., Lancet, Cell Transplantation, Experimental Gerontology, Frontiers in Bioengineering and Biotechnology, Pharmaceuticals, Cells). Parallel, regulatory and clinical work based on the same technology is on-going throughout Asia, following successful technology transfers and transpositions.

Although applied research continues on third- and fourth-generation PBBs within the CABMM, the evolving Swiss regulatory landscape now allows investigational clinical applications of allogeneic cytotherapies for severely burned patients. Overall, this will enable the continuation of the safe clinical practices introduced in Lausanne three decades ago, as well as the opening of new horizons for the use of locally-designed and standardized allogeneic cell-based treatments in Switzerland.

Marina Klawitter