Keratoconjunctivitis Sicca, in Sjogren's Syndrome
Conditions
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.
Interventions
DRUGASCs
ASCs expanded from healthy donors. The ASC product contains 22 million ASCs/ml.
DRUGCryostor CS10
CryoStor® CS10 freeze medium
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | 4 months after treatment | The OSDI is a valid and reliable instrument for measuring dry eye disease severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear meniscus height (TMH) | 4 months after treatment | As measured with the Keratograph 5M (Oculus™) |
| Schirmer's I test | 4 months after treatment | Change in tear production as evaluated with the Schirmer's I test |
| Non-invasive keratography tear break-up time (NIKBUT) | 4 months after treatment | As measured with the Keratograph 5M (Oculus™) |
| Oxford scale | 4 months after treatment | Change in staining of the ocular surface (grade 0-5 with 0 being absent corneal staining and 5 being severe corneal staining) |
| HLA anti-bodies | 12 months after treatment | Development of anti-human leucocyte antigen (HLA) anti-bodies evaluated with Luminex HLA anti-body screening Development of anti-HLA anti-bodies evaluated with Luminex HLA anti-body screening Development of donor-specific HLA-antibodies |
| Tear osmolarity | 4 months after treatment | Change in tear osmolarity measured with TearLab™ |
Countries
Denmark
Outcome results
None listed