NCT04615455: AMASS

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

Completed Phase 2 Last updated 8 March 2023

What this trial tests

Phase 2 trial testing ASCs in Keratoconjunctivitis Sicca, in Sjogren's Syndrome in 40 participants. Completed in 1 January 2023.

Timeline

3 November 2020

Primary endpoint
1 December 2022

1 January 2023

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	3 November 2020
Primary completion	1 December 2022
Estimated completion	1 January 2023
Sites	1 location across Denmark

Drugs / interventions tested

• ASCs — full drug profile →
• Cryostor CS10 — full drug profile →

Conditions studied

• Keratoconjunctivitis Sicca, in Sjogren's Syndrome — all drugs for Keratoconjunctivitis Sicca, in Sjogren's Syndrome →

Sponsor

Rigshospitalet, Denmark

Who can join

18 and older, any sex, with Keratoconjunctivitis Sicca, in Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dry eye syndrome: comprehensive etiologies and recent clinical trials.
   Huang R, Su C, Fang L, Lu J, et al · · 2022 · cited 52× · PMID 35678897 · DOI 10.1007/s10792-022-02320-7
2. Corneal Regeneration Using Adipose-Derived Mesenchymal Stem Cells.
   Alió Del Barrio JL, De la Mata A, De Miguel MP, Arnalich-Montiel F, et al · · 2022 · cited 48× · PMID 36010626 · DOI 10.3390/cells11162549
3. Mesenchymal stromal cells for the treatment of ocular autoimmune diseases.
   Oh JY, Lee RH. · · 2021 · cited 31× · PMID 33775824 · DOI 10.1016/j.preteyeres.2021.100967
4. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
5. Applications of mesenchymal stem cells in ocular surface diseases: sources and routes of delivery.
   Soleimani M, Masoumi A, Momenaei B, Cheraqpour K, et al · · 2023 · cited 27× · PMID 36719365 · DOI 10.1080/14712598.2023.2175605
6. Regenerative treatment of ophthalmic diseases with stem cells: Principles, progress, and challenges.
   Niu Y, Ji J, Yao K, Fu Q. · · 2024 · cited 25× · PMID 38586868 · DOI 10.1016/j.aopr.2024.02.001
7. Experimental Pharmacotherapy for Dry Eye Disease: A Review.
   Baiula M, Spampinato S. · · 2021 · cited 20× · PMID 33790661 · DOI 10.2147/jep.s237487
8. Mesenchymal Stromal Cell-Based Therapy for Dry Eye: Current Status and Future Perspectives.
   Jiang Y, Lin S, Gao Y. · · 2022 · cited 18× · PMID 36398793 · DOI 10.1177/09636897221133818