Normal Female Volunteers
Conditions
Brief summary
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.
Interventions
BIOLOGICALHP802-247
One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.
Sponsors
Healthpoint
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provide written informed consent. * Female, 18 years of age or older. * Any race or skin type, provided that there are no tattoos within 5 cm of the wound target, and the gentian violet surgical marker produces a clearly visible mark on the skin. * Willing to make all required study visits and, in the opinion of the Investigator, able to follow instructions. * Willing to undergo the repeated biopsy procedures. * Willing to undergo verification of sex chromosome status.
Exclusion criteria
* Males, or phenotypic females bearing Y-chromosome genetic material \[e.g., 46,X,(r)Y; 46,X,der(X)t(X;Y); sex reassignment surgery\]. * Contraindications or hypersensitivity to the use of the study medications or their components (e.g., history of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B). * History of keloid formation or hypertrophic scarring. * Participation in any interventional clinical trial within 30 days prior to screening. * History of prolonged bleeding, bleeding into joints, easy bruising following minor trauma, clotting factor deficiency, or current use of anticoagulants or platelet inhibitors. * Any medical condition which, in the opinion of the Co-Investigator, may interfere with normal wound repair. * Current therapy with drugs or biologics intended to function as immuno-suppressants, chronic (\> 10 days) oral corticosteroids, or any concomitant medication which, in the opinion of the Co-Investigator, may interfere with normal wound repair.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at a single US investigational site, between September 14, 2010 and December 08, 2010.
Pre-assignment details
Subjects underwent buccal smear to ensure absence of a Y chromosome or translocated material from a Y chromosome. Day 1, all subjects underwent a baseline 3mm skin punch biopsy on the inner upper arm followed by a single application of HP802-247.
Participants by arm
| Arm | Count |
|---|---|
| HP802-247 Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days
HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-compliance | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HP802-247 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 28 |
| serious Total, serious adverse events | 1 / 28 |
Outcome results
Primary
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
Population: 3 subjects were withdrawn; 2 for non-compliance and one at the subject's request. One subject, who was available to replace a subject assigned to a weekly cohort if the subject was unavailable, was assayed on Day 57 with the subjects assigned to the Week 8 cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HP802-247 | Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Week 1, Day 8 | 3 Participants |
| HP802-247 | Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Week 2, Day 15 | 1 Participants |
| HP802-247 | Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Week 3, Day 22 | 0 Participants |
| HP802-247 | Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Week 4, Day 29 | 0 Participants |
| HP802-247 | Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Week 5, Day 36 | 0 Participants |
| HP802-247 | Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Week 6, Day 43 | 0 Participants |
| HP802-247 | Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Week 7, Day 50 | 0 Participants |
| HP802-247 | Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. | Week 8 Day 57 | 0 Participants |
Secondary
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
Population: The analysis population consisted of the 8 cohorts of 3 subjects biopsied at weekly intervals over the 8-week duration of the study. It should be note that the cohort for Week 8 (Day 57) was composed of 4 subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HP802-247 | 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. | Partial DNA profile | 19 Days |
| HP802-247 | 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. | ≥ 50% of the 17 loci | 17 Days |
| HP802-247 | 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. | Complete DNA profile | 13 Days |