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

NCT ID: NCT01190865

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Normal Female Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

HP802-247

Intervention Type: BIOLOGICAL

One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.

Interventions

HP802-247

One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Healthpoint, Ltd

Barry Reece, MS

Role: PRINCIPAL_INVESTIGATOR

RCTS, Inc.

Locations

RCTS, Inc.

Irving, Texas, United States

Countries

United States

Other Identifiers

802-247-09-021

Identifier Type: -

Identifier Source: org_study_id