Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's Syndrome (AMASS)

Rigshospitalet

Status and phase: Completed; Phase 2

Conditions: Keratoconjunctivitis Sicca, in Sjogren's Syndrome

Treatments: Drug: Cryostor CS10; Drug: ASCs

Study type: Interventional

Funder types: Other

Identifiers

NCT04615455

2020-002804-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Adipose tissue-derived mesenchymal stem cells (ASCs)

Experimental group

Description:

One transconjunctival injection of allogeneic ASCs into the LG in one eye.

Treatment:

Drug: ASCs

Placebo (vehicle, Cryostor CS10)

Placebo Comparator group

Description:

One transconjunctival injection of Cryostor CS10 into the LG in one eye.

Treatment:

Drug: Cryostor CS10