In adult patients with recessive dystrophic epidermolysis bullosa (RDEB), are intradermal allogeneic cultured fibroblast wound injections in transport solution (Plasmalyte and 2% albumex) more effective than a placebo in promoting wound healing and collagen production?

Research Infrastructure Support Services (RISS)0 个研究点目标入组 5 人开始时间: 2010年9月14日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Diagnosis of Recessive dystrophic epidermolysis bullosa- generalized severe (RDEB-GS) (patients should have detectable low levels of collagen VII expression and reduced / abnormal anchoring fibrils on electron microscopy).
•2. At least 2 symmetric wounds on each side of the body (arms, chest/abdomen, legs) of approximately the same size (at least 4 cm2 as measured accurately by the Visitrak wound measurement system [Smith & Nephew Healthcare Ltd., Hull]).
•3. Ability to sign informed consent, which indicates the investigational nature of this study.
•4. Age: 18 years or older

•1. Clinical evidence of local infection of the targeted wound(s).
•2. Histopathologic evidence of malignancy (i.e. squamous cell carcinoma - SCC) of the targeted wound(s).
•3. Use of systemic or topical steroid therapy within 30 days before enrolment.
•4. Use of any investigational drug within the 30 days before enrolment.
•5. Patients considered by the investigators to be unreliable or have poor compliance
•6. Patients who are pregnant, or who suspect they may be pregnant at the time of the study and lactating women. Women of childbearing age should use effective contraception.

发起方

Research Infrastructure Support Services (RISS)