Fibrocell Science, Inc. provided an update on the interim results and progress of its Phase 1/2 clinical trial of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The results were presented by M. Peter Marinkovich, MD, the trial’s Study Director at the Stanford University site and Associate Professor of Dermatology at the Stanford University School of Medicine, at the 7th International Investigative Dermatology meeting on May 19, 2018. Four adult patients (n=7 wounds) aged 20 to 37 have been dosed with FCX-007 in the margins of and across targeted wounds, as well as in separate intact skin sites. Three patients received a single intradermal injection session at baseline. One patient received a second injection session in the remaining unhealed areas of wounds at 25 weeks post-administration, as allowed by the clinical trial protocol. Safety data from these patients show FCX-007 was well-tolerated up to 52 weeks post-administration. There were no serious adverse events and no product related adverse events reported. No type VII collagen (COL7) autoantibody response was noted. Various COL7 expression signals were detected throughout the data set using either immunofluorescence (IF) or immunoelectron microscopy (IEM) up to 52 weeks post-administration. Anchoring fibril structures have also been observed using IEM. Wounds were evaluated during a monitoring period prior to dosing and they were observed to be open for up to eight months. Compared to the baseline measurement collected at Day 0 before the administration of FCX-007, the percentage of dosed wounds healing > 50% when compared to baseline were observed as follows 100% (7/7) at 4 weeks post-administration. 86% (6/7) at 12 weeks. 67% (2/3) at 25/32 weeks. 100% (1/1) at 52 weeks. A similar trend was also observed for treated wounds healing > 75% when compared to baseline. Untreated wounds of similar size to the treated wounds were selected and monitored as controls on each patient. The percentage of untreated control wounds healing > 50% when compared to baseline were observed as follows 14% (1/7) at 4 weeks post-administration. 17% (1/6) at 12 weeks. 0% (0/2) at 25/32 weeks. 0% (0/1) at 52 weeks.