title: Cell Persistence of Allogeneic Keratinocytes and Fibroblasts Applied in a Fibrin Matrix to Acute, Full Thickness Wounds.
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.
authors: Healthpoint Biotherapeutics, Fort Worth, TX, USA; †Department of Cell Biology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.
authors: Jaime E
authors: JE
authors: Dickerson
authors: ‡ Department of Forensic and Investigative Genetics, University of North Texas Health Science Center , Fort Worth, TX , USA.
authors: John V
authors: JV
authors: Planz
authors: § RCTS, Inc. , Irving, TX , USA.
authors: Barry T
authors: BT
authors: Reece
authors: Healthpoint Biotherapeutics , Fort Worth, TX , USA.
authors: Kathy A
authors: KA
authors: Weedon
authors: ‡ Department of Forensic and Investigative Genetics, University of North Texas Health Science Center , Fort Worth, TX , USA.
authors: Sandy D
authors: SD
authors: Kirkpatrick
authors: Healthpoint Biotherapeutics, Fort Worth, TX, USA; ¶Department of Pediatrics, University of North Texas Health Science Center, Fort Worth, TX, USA.
authors: Herbert B
authors: HB
authors: Slade
keywords: Allogeneic cells; Fibroblasts (FBs); HP802-247; Keratinocytes (KCs); Wound healing; Y-STR