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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01190865
First received: August 26, 2010
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Normal Female Volunteers Biological: HP802-247 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Investigating the Survival of HP802-247 Allogeneic Cells in Excisional Acute Cutaneous Wounds

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy. [ Time Frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks ]

    The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM).

    Probit analysis was utilized to determine the 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. The analysis was performed using SAS® PROC PROBIT



Enrollment: 28
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190865

Locations
United States, Texas
RCTS, Inc.
Irving, Texas, United States
Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint, Ltd
Principal Investigator: Barry Reece, MS RCTS, Inc.
  More Information

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01190865     History of Changes
Other Study ID Numbers: 802-247-09-021
Study First Received: August 26, 2010
Results First Received: September 13, 2016
Last Updated: June 2, 2017

ClinicalTrials.gov processed this record on September 21, 2017