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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-03

Study Completion Date

2023-01-01

Brief Summary

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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.

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Detailed Description

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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

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Keratoconjunctivitis Sicca, in Sjogren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Adipose tissue-derived mesenchymal stem cells (ASCs)

One transconjunctival injection of allogeneic ASCs into the LG in one eye.

Group Type EXPERIMENTAL

ASCs

Intervention Type DRUG

ASCs expanded from healthy donors. The ASC product contains 22 million ASCs/ml.

Placebo (vehicle, Cryostor CS10)

One transconjunctival injection of Cryostor CS10 into the LG in one eye.

Group Type PLACEBO_COMPARATOR

Cryostor CS10

Intervention Type DRUG

CryoStor® CS10 freeze medium

Interventions

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ASCs

ASCs expanded from healthy donors. The ASC product contains 22 million ASCs/ml.

Intervention Type DRUG

Cryostor CS10

CryoStor® CS10 freeze medium

Intervention Type DRUG

Other Intervention Names

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Allogeneic adipose-derived mesenchymal stem cells

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Sjögren's syndrome according to the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjögren's syndrome
* OSDI-score ≥ 33
* Schirmer's test 1-5 mm/5 minutes
* NIKBUT \< 10 sec

Exclusion Criteria

* LG volume on MRI \< 0,2 cm3 in the study eye
* Previous treatment with ASCs or other stem cell products in the LG(s)
* Reduced immune response (e.g. HIV positive)
* Pregnancy or planned pregnancy within the next 2 years
* Breastfeeding
* Topical treatment with eye drops other than to treat dry eye disease (DED)
* Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No