Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VCT-01-treated STSG donor site wound | Experimental | Application of VCT-01 to STSG donor site wound at Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCT-01 | Device | Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Healing parameter | Percentage area of questionable viability | Day 4 post-treatment |
| Healing parameter | Percentage area of graft survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edward E Tredget, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 14 post-treatment |
| Healing parameter | Histological and immunohistochemical analyses to examine cellular composition and tissue architecture. | Up to 10 days post-treatment |
| Healing parameter | Microarray analysis to quantitatively measure molecular phenotypes expression. | Up to 10 days post-treatment |
| Healing parameter | Short tandem repeat analysis for persistence of VCT-01 | Up to 12 Months post-treatment |