Allogeneic growth arrested keratinocytes and fibroblasts delivered in a fibrin spray accelerate healing in mohs micrographic surgery wounds

摘要

Objectives: To determine the effectiveness of HP802-247 compared with bacitracin ointment in healing wounds resulting from Mohs micrographic surgery. Methods: Open-label, randomized pilot study conducted at a single center. Subjects were randomized to either HP802-247 (5M cells/mL) applied weekly or bacitracin ointment applied daily. Treatment continued for up to 12 weeks or complete wound closure. Primary efficacy was effectiveness as measured by the Investigator's Global Assessment of Healing (IGAH) scale. Secondary outcomes included median time to healing, investigator- and subject-scored signs and symptoms, and an assessment of scar by the investigator at 16 weeks postsurgery. Results: All subjects achieved favorable outcomes within the study period; however, these were reached more quickly for the HP802- 247 group than for bacitracin. At 3 weeks postsurgery, healing was assessed as very effective for 75% of subjects in the HP802-247 group compared with 50% for bacitracin. Median time to closure was 24.5 days for HP802-247 and 29 days for bacitracin. Scores for signs and symptoms and scar were similar for both groups but, in general, were numerically better for HP802-247. Conclusion: In this small pilot study, HP802-247 was found to provide a modest, incremental benefit in the healing of Mohs micrographic surgery wounds, suggesting that the healing of uncomplicated acute wounds may be slightly accelerated without enhancement of scarring.