Clinical trial NCT01190865: Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds
Official title: A Phase I Study Investigating the Survival of HP802-247 Allogeneic Cells in Excisional Acute Cutaneous Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Female Volunteers
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.
timeFrame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
Other outcomes:
Locations:
city: Irving
country: United States
facility: RCTS, Inc.
state: Texas
Study officials:
affiliation: Healthpoint, Ltd
name: Herbert B Slade, MD
role: STUDY_CHAIR
affiliation: RCTS, Inc.
name: Barry Reece, MS
role: PRINCIPAL_INVESTIGATOR
References: