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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: September 13, 2016
Last verified: September 2016

August 26, 2010
September 13, 2016
September 2010
December 2010   (final data collection date for primary outcome measure)
The Percentage of Participants With Persistence of the Y Chromosome in Growth Arrested, Allogeneic, Male-donor Keratinocytes and Fibroblasts When Applied to the Surface of Acute Excisional Wounds in Healthy Female Volunteers [ Time Frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks ] [ Designated as safety issue: No ]
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).
Presence of Y Chromosome Genetic Markers [ Time Frame: 57 Days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01190865 on ClinicalTrials.gov Archive Site
Determination of 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. [ Time Frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks ] [ Designated as safety issue: No ]
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).
Identification of Donor Cell Type [ Time Frame: 57 Days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds
A Phase I Study Investigating the Survival of HP802-247 Allogeneic Cells in Excisional Acute Cutaneous Wounds
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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Normal Female Volunteers
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.
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
Intervention: Biological: HP802-247
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01190865
802-247-09-021
No
Not Provided
Not Provided
Healthpoint
Healthpoint
Not Provided
Study Chair: Herbert B Slade, MD Healthpoint, Ltd
Principal Investigator: Barry Reece, MS RCTS, Inc.
Healthpoint
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP