- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190865
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Irving, Texas, United States
- RCTS, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Herbert B Slade, MD, Healthpoint, Ltd
- Principal Investigator: Barry Reece, MS, RCTS, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 802-247-09-021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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