Trial Outcomes & Findings for Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds (NCT NCT01190865)

NCT ID: NCT01190865

Last Updated: 2017-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks

Results posted on

2017-07-02

Participant Flow

Subjects were enrolled at a single US investigational site, between September 14, 2010 and December 08, 2010.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study Non-compliance	2

Baseline Characteristics

Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HP802-247 n=28 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HP802-247 n=25 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.
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. Week 1, Day 8	3 Participants
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. Week 2, Day 15	1 Participants
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. Week 3, Day 22	0 Participants
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. Week 4, Day 29	0 Participants
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. Week 5, Day 36	0 Participants
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. Week 6, Day 43	0 Participants
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. Week 7, Day 50	0 Participants
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. Week 8 Day 57	0 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	HP802-247 n=25 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.
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 Interval 0.0 to 30.0
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 Interval 0.0 to 28.0
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 Interval 0.0 to 24.0

Adverse Events

HP802-247

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HP802-247 n=28 participants at risk 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.
Reproductive system and breast disorders Pelvic Pain	3.6% 1/28 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	HP802-247 n=28 participants at risk 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.
Infections and infestations Furuncle	3.6% 1/28 • Number of events 1 • 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.
Infections and infestations Nasopharyngitis	3.6% 1/28 • Number of events 1 • 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.
Infections and infestations Sinusitis	7.1% 2/28 • Number of events 2 • 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.
Infections and infestations Urinary Tract Infection (UTI)	3.6% 1/28 • Number of events 1 • 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.
Injury, poisoning and procedural complications Human Bite	3.6% 1/28 • Number of events 1 • 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.
Injury, poisoning and procedural complications Skin Laceration	3.6% 1/28 • Number of events 1 • 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.
Investigations Blood Cholesterol Increase	3.6% 1/28 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Trigger Finger	3.6% 1/28 • Number of events 1 • 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.
Nervous system disorders Migraine	3.6% 1/28 • Number of events 1 • 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.
Psychiatric disorders Insomnia	3.6% 1/28 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Nail Disorder	3.6% 1/28 • Number of events 1 • 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.

Additional Information

Jaime E Dickerson, PhD

Smith & Nephew

Phone: 1-817-302-3914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60