A Single-Center, Prospective, Randomized Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age but no more than 55 years of age.
- •Subject has a primary wound which requires treatment with a split-thickness skin graft; the graft cannot be harvested from a site from which a skin graft was previously obtained. If the primary wound is a result of a thermal or chemical burn, the total body surface area must be less than 15%.
- •Females of childbearing potential must have a documented negative urine pregnancy test and must agree to use highly effective contraceptives for 6 months post-treatment.
- •Subject has read, understood and signed a Health Research Ethics Board-approved Informed Consent Form.
- •Subject is able and willing to comply with study procedures and instructions.
排除标准
- •Female subjects who are pregnant or lactating.
- •Clinically significant disease or condition that may compromise graft take and/or donor site healing (e.g. the presence of a bleeding disorder, capillary fragility, venous or arterial disorder directly affecting the donor site to be treated, known or suspected systemic malignancies, human immunodeficiency virus infection, renal or liver disease, uncontrolled diabetes mellitus, thrombocytopenia, vasculitis, poor nutritional status).
- •Subjects who are currently receiving or have received within two months prior to treatment: systemic, inhaled or intranasal corticosteroids or immunosuppressant agents. Subjects receiving therapeutic doses of anticoagulants for pre-existing medical conditions (e.g. Plavix, Coumadin, Heparin, low molecular weight Heparin, non-steroidal anti-inflammatory drugs, herbal supplements), for whom a dose interruption from Screening through 2-Months post-treatment (pre-treatment / treatment / biopsy phase) is contraindicated, are excluded from the study.
- •Any disorder (psychiatric, alcohol or substance abuse [within 12 months of treatment], physical disability) that might interfere with obtaining informed consent or the subject's ability to comply with study or protocol requirements, as determined by the Investigator.
- •Subjects who have used any tobacco product within 3 months prior to treatment.
- •Subjects previously treated with Apligraf®, Dermagraft or any other cell-based product, including autologous tissue at the treatment site.
- •Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to treatment (medical or dental).
- •Subjects, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
- •Subjects, as determined by Screening immunology testing, that have specific antibodies to VCT-01 donor cell human leukocyte antigens.
结局指标
主要结局
Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 Months
时间窗: Up to 12 months post-treatment
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
次要结局
- Healing parameter(Up to 12 Months post-treatment)