A Randomized Clinical Trial Evaluating Allogeneic Adipose-derived MesenchymAl Stem Cells as a Treatment of Dry Eye Disease in Patients With Sjögren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
AMASS is a double-blinded randomized clinical trial with the purpose of investigating whether injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) results in increased ocular comfort compared to placebo.
详细描述
AMASS is a double-blinded randomized clinical trial which will be performed at the Department of Ophthalmology, University Hospital of Copenhagen, Denmark. 40 patients with severe aqueous deficient dry eye disease (ADDE) due to Sjögren's Syndrome (SS) will be recruited from the Dept. of Ophthalmology, Rigshospitalet, and allocated in ratio 1:1 to either injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) or placebo (vehicle, Crystore CS10) into the lacrimal gland (LG) in one eye. We hypothesize that injection of allogeneic ASCs into the LG increases tear production and reduce inflammation resulting in increased ocular comfort compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 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
排除标准
- •LG volume on MRI < 0,2 cm3 in the study eye
- •Previous treatment with ASCs or other stem cell products in the LG(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 disease (DED)
- •Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye
研究组 & 干预措施
Adipose tissue-derived mesenchymal stem cells (ASCs)
One transconjunctival injection of allogeneic ASCs into the LG in one eye.
干预措施: ASCs (Drug)
Placebo (vehicle, Cryostor CS10)
One transconjunctival injection of Cryostor CS10 into the LG in one eye.
干预措施: Cryostor CS10 (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: 4 months after treatment
The OSDI is a valid and reliable instrument for measuring dry eye disease severity
次要结局
- Tear osmolarity(4 months after treatment)
- Schirmer's I test(4 months after treatment)
- Non-invasive keratography tear break-up time (NIKBUT)(4 months after treatment)
- Tear meniscus height (TMH)(4 months after treatment)
- Oxford scale(4 months after treatment)
- HLA anti-bodies(12 months after treatment)
研究者
Michael Møller-Hansen
Principal investigator
Rigshospitalet, Denmark