A Randomized Clinical Trial Evaluating Allogeneic Adipose-derived MesenchymAl Stem Cells as a Treatment of Dry Eye Disease in Patients With Sjögren's Syndrome
Overview
- Phase
- Phase 2
- Intervention
- ASCs
- Conditions
- Keratoconjunctivitis Sicca, in Sjogren's Syndrome
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Ocular Surface Disease Index (OSDI)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Michael Møller-Hansen
Principal investigator
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Adipose tissue-derived mesenchymal stem cells (ASCs)
One transconjunctival injection of allogeneic ASCs into the LG in one eye.
Intervention: ASCs
Placebo (vehicle, Cryostor CS10)
One transconjunctival injection of Cryostor CS10 into the LG in one eye.
Intervention: Cryostor CS10
Outcomes
Primary Outcomes
Ocular Surface Disease Index (OSDI)
Time Frame: 4 months after treatment
The OSDI is a valid and reliable instrument for measuring dry eye disease severity
Secondary Outcomes
- 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)