A Phase I Open-Label Trial to Determine the Safety of PEP on a Skin Graft Donor Site Wound
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Rion Inc.
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel
研究概览
简要总结
The purpose of this study is to determine the safety of a biological therapeutic PEP in participants who have skin graft donor site wounds.
详细描述
This is an open label phase 1b study of PEP (a leukocyte depleted blood preparation derived from human U.S. sourced pooled apheresed platelets) in patients with at least two donor split-thickness skin graft wounds. One donor site will be treated with the standard post-operative dressing, while the other site will be treated with PEP or PEP+TISSEEL and covered with a standard dressing. TISSEEL is a commercially available fibrin sealant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
20% PEP and TISSEEL
Cohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound.
干预措施: TISSEEL (Drug)
10 % PEP only
Cohort 1: Subjects will receive 10% PEP to the skin graft donor wound.
干预措施: 10% PEP (Biological)
20% PEP only
Cohort 2: Subjects will receive 20% PEP to the skin graft donor wound
干预措施: 20% PEP (Biological)
20% PEP and TISSEEL
Cohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound.
干预措施: 20% PEP (Biological)
结局指标
主要结局
Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel
时间窗: Up to 2 weeks (within the first 14 days) for each dosing cohort
The primary endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of DLTs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day DLT period.
Maximum Tolerated Dose (MTD) of PEP / PEP-Tisseel
时间窗: Up to 2 weeks (within the first 14 days) for each dosing cohort
The endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of MTDs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day MTD period.
次要结局
- Long Term safety of PEP / PEP-Tisseel(6 months)