A Phase 2 interventional study of ASCs and Cryostor CS10 in Keratoconjunctivitis Sicca, in Sjogren's Syndrome, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Rigshospitalet, Denmark · Phase 2, Interventional, and Treatment
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.
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.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 40 is below the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One transconjunctival injection of allogeneic ASCs into the LG in one eye.
Drug: ASCs
One transconjunctival injection of Cryostor CS10 into the LG in one eye.
Drug: Cryostor CS10
ASCs expanded from healthy donors. The ASC product contains 22 million ASCs/ml.
Also known as: Allogeneic adipose-derived mesenchymal stem cells
CryoStor® CS10 freeze medium
Ocular Surface Disease Index (OSDI)
The OSDI is a valid and reliable instrument for measuring dry eye disease severity
Time frame: 4 months after treatment
Non-invasive keratography tear break-up time (NIKBUT)
As measured with the Keratograph 5M (Oculus™)
Time frame: 4 months after treatment
Tear meniscus height (TMH)
As measured with the Keratograph 5M (Oculus™)
Time frame: 4 months after treatment
Schirmer's I test
Change in tear production as evaluated with the Schirmer's I test
Time frame: 4 months after treatment
Tear osmolarity
Change in tear osmolarity measured with TearLab™
Time frame: 4 months after treatment
Oxford scale
Change in staining of the ocular surface (grade 0-5 with 0 being absent corneal staining and 5 being severe corneal staining)
Time frame: 4 months after treatment
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
Time frame: 12 months after treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2020 to primary completion in Dec 2022, 24 months.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Allogeneic Adipose-derived Mesenchymal Stem Cells