Abstract
HP802-247 is a living cell suspension of cultured allogeneic growth-arrested human male keratinocytes and fibroblasts (1:9 ratio), intended for spray application to chronic wounds. In this study, a small wound was created on the arms of 28 healthy female volunteers (3-mm punch), followed by a single application of HP802-247. At each subsequent week for 8 weeks, a punch excision of the wounds was performed on a cohort of three subjects. Excised specimens were analyzed for allogeneic fibroblast and keratinocyte DNA determined by Y-chromosome short-tandem repeats using PCR amplification followed by capillary electrophoresis, a method with estimated sensitivity of 1 male cell in a background of 8,000 female cells. A complete haplotype attributable to HP802-247 fibroblasts was detected in three of three samples at 1 week, with one partial and one complete fibroblast haplotype detected at 2 weeks, and one partial keratinocyte haplotype detected at 3 weeks postapplication. The findings indicate that HP802-247 can be expected to persist in an acute wound bed for up to 2 weeks postapplication.