A phase I/II study evaluating allogeneic mesenchymal stromal cells in adults with recessive dystrophic epidermolysis bullosa - ADSTEM

King's College London0 个研究点目标入组 10 人开始时间: 2014年12月22日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1) Individuals with a diagnosis of RDEB confirmed by DNA analysis .
•2) Individuals = 18 years and = 65 years of age, both male and female
•3) Individuals that have voluntarily signed and dated an informed consent form (ICF) prior to the first study intervention
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase.
•2) Subjects who have received immunotherapy including oral corticosteroids for more than 1 week (intranasal and topical preparations are permitted).
•3) Subjects with a known allergy to any of the constituents of the investigational product.
•4) Subjects with a medical history or evidence of malignancy, including cutaneous squamous cell carcinoma.
•5) Subjects who are pregnant or of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase.
•6) Subjects with both a) positive C7 ELISA and b) a positive indirect immunofluorescence (IIF) with binding to the base of salt split skin.

发起方