Phase 1
N=28
Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds
Normal Female Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT01190865 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Nov 2016
Primary outcome: Primary: Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. — 3; 1; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- HP802-247 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Healthpoint
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. |
3; 1; 0; 0; 0; 0 | — |
| 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. |
19; 17; 13 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01190865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.