A clinical trial in which treatment with stem cells derived from adipose-tissue of healthy donors is tested in patients with reduced tear production due to Sjögren's Syndrome

A randomized clinical trial evaluating allogeneic adipose-derived mesenchymal stem cells as a treatment of dry eye disease in Sjögren's Syndrome - AMASS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002804-38-DK

Enrollment

Registered

2020-06-16

Start date

2020-08-12

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The trial will include participants with Aqueous Deficient Dry Eye Disease due to Sjögrens syndrom (International Classification of Diseases-10: DM 350A) MedDRA version: 20.0 Level: LLT Classification code 10023350 Term: Keratoconjunctivitis sicca System Organ Class: 100000004853

Interventions

Product Name: Allogeneic adipose tissue-derived stromal/stem cells Product Code: CSCC_ASC(22) Pharmaceutical Form: Solution for injection INN or Proposed INN: CSCC_ASC(22) Other descriptive name: ALLO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 18 years 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Lacrimal gland volume on MRI < 0,2 cm3 in the study eye Previous treatment with ASCs or other stem cell products in the lacrimal gland(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 diease Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye

Design outcomes

Primary

Measure	Time frame
Main Objective: Our objective is to assess the efficacy of allogeneic adipose-tissue derived mesenchymal stem cells (ASCs) administered for lacrimal gland hypofunction in patients with ADDE due to Sjögren's syndrome;Secondary Objective: Our secondary objective is to assess whether injection of allogeneic ASCs results in any adverse reactions to the IMP;Primary end point(s): Change in OSDI-score;Timepoint(s) of evaluation of this end point: 1 week, 4 weeks, 4 months and 12 months after treatment	—

Measure

Time frame

Main Objective: Our objective is to assess the efficacy of allogeneic adipose-tissue derived mesenchymal stem cells (ASCs) administered for lacrimal gland hypofunction in patients with ADDE due to Sjögren's syndrome;Secondary Objective: Our secondary objective is to assess whether injection of allogeneic ASCs results in any adverse reactions to the IMP;Primary end point(s): Change in OSDI-score;Timepoint(s) of evaluation of this end point: 1 week, 4 weeks, 4 months and 12 months after treatment

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are change in TMH and NIKBUT-first using the K5M, change in tear production as evaluated with the Schirmer’s I test, change in tear osmolarity, and change in ocular surface staining evaluated with the Oxford score. All adverse events (AEs) and severe adverse events (SAEs) will be recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE).;Timepoint(s) of evaluation of this end point: 1 week, 4 weeks, 4 months and 12 months after treatment	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are change in TMH and NIKBUT-first using the K5M, change in tear production as evaluated with the Schirmer’s I test, change in tear osmolarity, and change in ocular surface staining evaluated with the Oxford score. All adverse events (AEs) and severe adverse events (SAEs) will be recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE).;Timepoint(s) of evaluation of this end point: 1 week, 4 weeks, 4 months and 12 months after treatment

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Countries

Denmark

Contacts

Public ContactMichael Møller-Hansen

Department of Ophtalmology, RigshospitaletGlostrup

michael.moeller-hansen@regionh.dk+4593901230

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026