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

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark

Criteria

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