A randomized clinical trial evaluating allogeneic adipose-derived mesenchymal stem cells as a treatment of dry eye disease in Sjögren's Syndrome - AMASS

Rigshospitalet-Glostrup0 个研究点目标入组 40 人开始时间: 2020年6月16日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•Age > 18 years
•Diagnosis of Sjögren’s syndrome according to the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjögren's syndrome
•OSDI-score = 33
•Schirmer’s test 1-5 mm/5 minutes
•NIKBUT < 10 sec
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Lacrimal gland volume on MRI < 0,2 cm3 in the study eye
•Previous treatment with ASCs or other stem cell products in the lacrimal gland(s)
•Reduced immune response (e.g. HIV positive)
•Pregnancy or planned pregnancy within the next 2 years
•Breastfeeding
•Topical treatment with eye drops other than to treat dry eye diease
•Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye

发起方