EUCTR2011-003212-22-GB进行中(未招募)1 期
Phase I study of ex-vivo lentiviral gene therapy for the inherited skin disease Netherton Syndrome - Gene Therapy for Netherton Syndrome
GOSH/ICH Joint Research & Development Office0 个研究点目标入组 5 人开始时间: 2013年3月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Confirmed SPINK5 mutations in both alleles by direct DNA sequencing
- •2. Absence of LEKTI protein expression in the skin by in situ immunostaining
- •3. Patient informed consent, or parental/guardian consent in the case of minor
- •participant
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. History of skin malignancy or evidence of current active malignant skin disease
- •2. Pregnancy
- •3. Hepatitis A, B, C or HIV positive
- •4. Current antibiotic resistant bacterial colonisation
研究者
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