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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HP802-247 | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HP802-247 | Biological | One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Healthpoint, Ltd | Study Chair |
| Barry Reece, MS | RCTS, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RCTS, Inc. | Irving | Texas | United States |
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.
Subjects were enrolled at a single US investigational site, between September 14, 2010 and December 08, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks |
|
Safety reporting occurred over the eight weeks of the study.
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA v 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Furuncle | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime E Dickerson, PhD | Smith & Nephew | 1-817-302-3914 | Jaime.Dickerson@smith-nephew.com |
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| Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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.
|
|
| 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 | 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 | Posted | Number | 95% Confidence Interval | Days | Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks |
|
|
|
| 1 |
| 28 |
| 8 |
| 28 |
| Nasopharyngitis | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
|
| Urinary Tract Infection (UTI) | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
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| Human Bite | Injury, poisoning and procedural complications | MedDRA v 12.0 | Systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA v 12.0 | Systematic Assessment |
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| Blood Cholesterol Increase | Investigations | MedDRA v 12.0 | Systematic Assessment |
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| Trigger Finger | Musculoskeletal and connective tissue disorders | MedDRA v 12.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA v 12.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v 12.0 | Systematic Assessment |
|
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA v 12.0 | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|