Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds
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|ClinicalTrials.gov Identifier: NCT01190865|
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : November 1, 2016
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Normal Female Volunteers||Biological: HP802-247||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Investigating the Survival of HP802-247 Allogeneic Cells in Excisional Acute Cutaneous Wounds|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190865
|United States, Texas|
|Irving, Texas, United States|
|Study Chair:||Herbert B Slade, MD||Healthpoint, Ltd|
|Principal Investigator:||Barry Reece, MS||RCTS, Inc.|