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

Healthpoint

Status and phase: Completed; Phase 1

Conditions: Normal Female Volunteers

Treatments: Biological: HP802-247

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190865

802-247-09-021

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

HP802-247

Other group

Description:

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

Treatment:

Biological: HP802-247