Safety Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds
The purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated donor site.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Center, Prospective, Randomized Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds|
- Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 Months [ Time Frame: Up to 12 months post-treatment ] [ Designated as safety issue: Yes ]Frequency and severity of reported adverse events and changes in results of immunology testing at Months 1, 3, 6 and 12 post-treatment as compared to baseline testing
- Healing parameter [ Time Frame: Day 4 post-treatment ] [ Designated as safety issue: No ]Percentage area of questionable viability
- Healing parameter [ Time Frame: Day 14 post-treatment ] [ Designated as safety issue: No ]Percentage area of graft survival
- Healing parameter [ Time Frame: Up to 10 days post-treatment ] [ Designated as safety issue: No ]Histological and immunohistochemical analyses to examine cellular composition and tissue architecture.
- Healing parameter [ Time Frame: Up to 10 days post-treatment ] [ Designated as safety issue: No ]Microarray analysis to quantitatively measure molecular phenotypes expression.
- Healing parameter [ Time Frame: Up to 12 Months post-treatment ] [ Designated as safety issue: No ]Short tandem repeat analysis for persistence of VCT-01
|Study Start Date:||June 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: VCT-01-treated STSG donor site wound
Application of VCT-01 to STSG donor site wound at Day 0
Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0
An initial cohort of 5 subjects will be allocated to Group A. When all subjects enrolled in Group A have completed 14 days of post-treatment follow-up, results of donor site evaluations, histological analyses and reported adverse events will be reviewed by the Investigator and study Sponsor. If the data is suggestive of clinical benefit following treatment and absent any serious and/or unexpected adverse events, which are, in the opinion of the investigator, related to the treatment, the remaining subjects will be enrolled and randomized to Groups B, C or D.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292122
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Edward E Tredget, MD||University of Alberta|