Status:
COMPLETED
Treatment With Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Aqueous Deficient Dry Eye Disease
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Dry Eye
Kerato Conjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 patient...
Detailed Description
Dry eye disease (DED) is a very common problem seen in patients all over the world. According to an older study the prevalence of DED in a Danish population 30-60 years of age was 11%. Aqueous tear de...
Eligibility Criteria
Inclusion
- OSDI-score \> 30
- Schirmer's test 2-5 mm in 5 minutes
- TBUT \< 10 sec.
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03878628
Start Date
October 16 2019
End Date
February 20 2023
Last Update
November 18 2023
Active Locations (1)
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1
Rigshospitalet
Copenhagen, DK, Denmark, 2200