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

NCT01190865 | Completed Phase 1 Results

• 1 other identifier: 802-247-09-021
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.

  The primary efficacy variable was detection of the full set of 17 Y STR loci. If all loci amplified such that a clear identification of a donor was possible, the test result was categorized as positive. If fewer loci amplified such that identification of the donor was not possible in a forensic setting, the result was categorized as negative. Descriptive statistics are presented for this variable.

  Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks

Secondary Outcomes (1)

• 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.

  Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks

Study Arms (1)

HP802-247

OTHER

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

Biological: HP802-247

Interventions

HP802-247 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.

HP802-247

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (1)

RCTS, Inc.

Irving, Texas, United States

Location

Results Point of Contact

• Title: Jaime E Dickerson, PhD
• Organization: Smith & Nephew

Jaime.Dickerson@smith-nephew.com

1-817-302-3914

Study Officials

• Herbert B Slade, MD

  Healthpoint, Ltd

  STUDY CHAIR

• Barry Reece, MS

  RCTS, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 2, 2017
• Results First Posted: November 1, 2016

Record last verified: 2017-06

Locations

US (1)