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CompletedNCT01190865Updated Jul 2, 2017Results posted

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

A Phase 1 interventional study of HP802-247 in Normal Female Volunteers, sponsored by Healthpoint. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by Healthpoint · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Normal Female Volunteers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Other
    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

    Biological: HP802-247

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.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

06

Results

Posted Nov 1, 2016

Participant flow

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

Participant flow — Overall Study
MilestoneHP802-247
Started28
Completed25
Not completed3
Withdrew: Withdrawal by subject1
Withdrew: Non-compliance2

Outcome measures

PrimaryIdentification 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
Reported as:
Count of participants · Participants
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.
ParticipantsHP802-247
Week 1, Day 83
Week 2, Day 151
Week 3, Day 220
Week 4, Day 290
Week 5, Day 360
Week 6, Day 430
Week 7, Day 500
Week 8 Day 570
SecondaryTime 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
Reported as:
Number · Days
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.
DaysHP802-247
Partial DNA profile19 (0 to 30)
≥ 50% of the 17 loci17 (0 to 28)
Complete DNA profile13 (0 to 24)

Adverse events

Collected over Safety reporting occurred over the eight weeks of the study.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HP802-247—1/28 (3.6%)8/28 (28.6%)
Most frequent serious events
Most frequent serious events
EventHP802-247
Pelvic PainReproductive system and breast disorders1/28
Most frequent other events
Showing 10 of 11
Most frequent other events
EventHP802-247
SinusitisInfections and infestations2/28
FuruncleInfections and infestations1/28
NasopharyngitisInfections and infestations1/28
Urinary Tract Infection (UTI)Infections and infestations1/28
Human BiteInjury, poisoning and procedural complications1/28
Skin LacerationInjury, poisoning and procedural complications1/28
Blood Cholesterol IncreaseInvestigations1/28
Trigger FingerMusculoskeletal and connective tissue disorders1/28
MigraineNervous system disorders1/28
InsomniaPsychiatric disorders1/28

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)HP802-247
<=18 years0
Between 18 and 65 years27
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)HP802-247
Female28
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)HP802-247
Hispanic or Latino3
Not Hispanic or Latino25
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)HP802-247
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American5
White23
More than one race0
Unknown or Not Reported0
07

Study locations

1 site
  • RCTS, Inc.
    Irving, Texas, United States
08

Registry details

Key details

Study ID
NCT01190865
Lead sponsor
Healthpoint
Responsible party
Sponsor
First posted
Aug 30, 2010
Start date
Sep 2010
Primary completion
Dec 2010
Completion
Dec 2010
Results posted
Nov 1, 2016
Last update
Jul 2, 2017

Study contacts

Herbert B Slade, MD
study chair · Healthpoint, Ltd
Barry Reece, MS
principal investigator · RCTS, Inc.

Oversight

Data monitoring committee
No
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