NCT06731933招募中2 期
Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Recurrence rate of Squamous Cell Carcinoma
研究概览
简要总结
The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence.
Prevention of SCC's in the RDEB subjects will increase their life span.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
- •Presence of biopsy proven squamous cell carcinoma (SCC)
- •Ability to understand and the willingness to provide written informed consent.
- •US based participants are willing to use beremagene geperpavec (BVEC)
- •Subject is 18 years or older
- •participant willingness to use an effective method of contraception
排除标准
- •Inability to travel to site for study visit
- •Subject is pregnant
- •Subject has Metastatic SCC's or is on any current systemic treatment for SCC.
研究组 & 干预措施
Treatment with BVEC
Active Comparator
干预措施: BVEC (Drug)
No treatment with BVEC
No Intervention
结局指标
主要结局
Recurrence rate of Squamous Cell Carcinoma
时间窗: 2 years
The outcome measure is recurrence rate of SCC following BVEC application at each SCC lesion
次要结局
未报告次要终点
研究者
研究点 (2)
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