Safety of clinical pEVs
deaths, cosmetic deformities
ADVERSE EVENTS, SCAR
The safety of the clinical pEV treatment was assessed using a prospective, randomised, double‐blind, placebo‐controlled, single dose, phase I clinical trial. After receiving a skin punch biopsy wound to each inner arm, 11 participants were randomised and treated with clinical pEVs to one wound and with placebo to the comparator wound. All 11 participants completed the study (i.e., 100.0%). Most participants were male (8/11, 72.7%) and white (10/11, 90.9%), with a mean age of 29.0 years (Table No reported study deaths, serious adverse events, or adverse events leading to withdrawal of a study participant, were recorded (Table Clinical pEV‐treated wounds healed successfully. A mean healing time of 22.8 ± 8.7 days was recorded for both the clinical pEV and the placebo groups. All (11 of 11 [100.0%]) participants had achieved wound closure at Day 30 of the treatment period for both treatment groups and no abnormal scar formation or other cosmetic deformities were recorded (Figure (a) Plot of wound healing rate, showing the wound diameter (defined as the sum of the vertical and horizontal diameter) of treated (red) and untreated (blue) 4 mm punch biopsy induced wounds over time. (b) Plot of wound healing rate, showing the number of treated (red) and untreated (blue) wounds to have completely healed, as recorded during participant physical examination.