Overview

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