The goal for this study is to examine the persistence of growth arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured using Y-STR for detection of Y-chromosome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.
RCTS, Inc.
Irving, Texas, United States
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.
The primary efficacy variable was detection of the full set of 17 Y STR loci. If all loci amplified such that a clear identification of a donor was possible, the test result was categorized as positive. If fewer loci amplified such that identification of the donor was not possible in a forensic setting, the result was categorized as negative. Descriptive statistics are presented for this variable.
Time frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
Time in Days to 50% Correct Identification (ID50) of the Implanted Male DNA 17 Loci in Female Volunteers, With Regard to Three DNA Profile Types, Including Partial DNA Profile, > 50% DNA Profile, and Full (or Complete) DNA Profile.
The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM). Probit analysis was utilized to determine the time in days to 50% correct identification (ID50) of the implanted male DNA 17 loci in female volunteers, with regard to three DNA profile types, including partial DNA profile, \> 50% DNA profile, and full (or complete) DNA profile. The analysis was performed using SAS® PROC PROBIT
Time frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
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