Treatment With Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Aqueous Deficient Dry Eye Disease

001-2018

The objective of this study is to assess the safety and feasibility of allogeneic adipose tissue-derived mesenchymal stem cells (ASCs) injected into the lacrimal gland in a smaller groups of 7 patients with Aqueous Deficient Dry Eye Disease (ADDE)

2019-10-16

2020-06-30

2023-02-20

Completed

Early phase I

7

Inclusion Criteria: * OSDI-score \> 30 * Schirmer's test 2-5 mm in 5 minutes * TBUT \< 10 sec. Exclusion Criteria: * Previously established allergies to Oxybuprocaine or DMSO (rare) * Reduced immune response (e.g. HIV positive) * Pregnancy or planned pregnancy within the next 2 years * Breastfeeding * Treatment with an anticoagulant that cannot be stopped during the intervention period * Treatment with systemic medication known to reduce tear production (with an odds ratio \>2,0 (3)): anxiolytics, antipsychotics, and inhaled steroids. * Topical treatment with eye drops other than lubricants * Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}

2023-11-18