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

Keratoconjunctivitis Sicca, in Sjogren's Syndrome Clinical Trial

— AMASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615455
• Other study ID #: 2020-002804-38
• Status: Completed
• Phase: Phase 2
• Start date: November 3, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• Keratoconjunctivitis Sicca, in Sjogren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• ASCs
ASCs expanded from healthy donors. The ASC product contains 22 million ASCs/ml.
• Cryostor CS10
CryoStor® CS10 freeze medium

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	DK

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index (OSDI)	The OSDI is a valid and reliable instrument for measuring dry eye disease severity	4 months after treatment
Secondary	Non-invasive keratography tear break-up time (NIKBUT)	As measured with the Keratograph 5M (Oculus™)	4 months after treatment
Secondary	Tear meniscus height (TMH)	As measured with the Keratograph 5M (Oculus™)	4 months after treatment
Secondary	Schirmer's I test	Change in tear production as evaluated with the Schirmer's I test	4 months after treatment
Secondary	Tear osmolarity	Change in tear osmolarity measured with TearLab™	4 months after treatment
Secondary	Oxford scale	Change in staining of the ocular surface (grade 0-5 with 0 being absent corneal staining and 5 being severe corneal staining)	4 months after treatment
Secondary	HLA anti-bodies	Development of anti-human leucocyte antigen (HLA) anti-bodies evaluated with Luminex HLA anti-body screening; Development of anti-HLA anti-bodies evaluated with Luminex HLA anti-body screening; Development of donor-specific HLA-antibodies	12 months after treatment