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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0
University of Alberta Hospital
Edmonton, Alberta, Canada
Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 Months
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
Time frame: Up to 12 months post-treatment
Healing parameter
Percentage area of questionable viability
Time frame: Day 4 post-treatment
Healing parameter
Percentage area of graft survival
Time frame: Day 14 post-treatment
Healing parameter
Histological and immunohistochemical analyses to examine cellular composition and tissue architecture.
Time frame: Up to 10 days post-treatment
Healing parameter
Microarray analysis to quantitatively measure molecular phenotypes expression.
Time frame: Up to 10 days post-treatment
Healing parameter
Short tandem repeat analysis for persistence of VCT-01
Time frame: Up to 12 Months post-treatment
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