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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark

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