NCT04615455

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

A Randomized Clinical Trial Evaluating Allogeneic Adipose-derived MesenchymAl Stem Cells as a Treatment of Dry Eye Disease in Patients With Sjögren's Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

AMASS is a double-blinded randomized clinical trial which will be performed at the Department of Ophthalmology, University Hospital of Copenhagen, Denmark. 40 patients with severe aqueous deficient dry eye disease (ADDE) due to Sjögren's Syndrome (SS) will be recruited from the Dept. of Ophthalmology, Rigshospitalet, and allocated in ratio 1:1 to either injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) or placebo (vehicle, Crystore CS10) into the lacrimal gland (LG) in one eye. We hypothesize that injection of allogeneic ASCs into the LG increases tear production and reduce inflammation resulting in increased ocular comfort compared to placebo.

Conditions

• Keratoconjunctivitis Sicca, in Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	ASCs	ASCs expanded from healthy donors. The ASC product contains 22 million ASCs/ml.
DRUG	Cryostor CS10	CryoStor® CS10 freeze medium

Timeline

• Start date: 2020-11-03
• Primary completion: 2022-12-01
• Completion: 2023-01-01
• First posted: 2020-11-04
• Last updated: 2023-03-08

Locations

1 site across 1 country: Denmark