Status:
COMPLETED
Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds
Lead Sponsor:
Healthpoint
Conditions:
Normal Female Volunteers
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01190865
Start Date
September 1 2010
End Date
December 1 2010
Last Update
July 2 2017
Active Locations (1)
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1
RCTS, Inc.
Irving, Texas, United States