NCT04615455

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

November 3, 2020

Last Update Submit

March 7, 2023

Conditions

Keratoconjunctivitis Sicca, in Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

  • Ocular Surface Disease Index (OSDI)

    The OSDI is a valid and reliable instrument for measuring dry eye disease severity

    4 months after treatment

Secondary Outcomes (6)

  • Non-invasive keratography tear break-up time (NIKBUT)

    4 months after treatment

  • Tear meniscus height (TMH)

    4 months after treatment

  • Schirmer's I test

    4 months after treatment

  • Tear osmolarity

    4 months after treatment

  • Oxford scale

    4 months after treatment

  • +1 more secondary outcomes

Study Arms (2)

Adipose tissue-derived mesenchymal stem cells (ASCs)

EXPERIMENTAL

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

Drug: ASCs

Placebo (vehicle, Cryostor CS10)

PLACEBO COMPARATOR

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

Drug: Cryostor CS10

Interventions

ASCsDRUG

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

Also known as: Allogeneic adipose-derived mesenchymal stem cells
Adipose tissue-derived mesenchymal stem cells (ASCs)
Cryostor CS10DRUG

CryoStor® CS10 freeze medium

Placebo (vehicle, Cryostor CS10)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, DK, 2200, Denmark

Location

Related Publications (1)

  • Larsen AC, Moller-Hansen M, Wiencke AK, Terslev L, Torp-Pedersen S, Heegaard S. Ultrasound-Guided Transcutaneous Injection in the Lacrimal Gland: A Description of Sonoanatomy and Technique. J Ocul Pharmacol Ther. 2023 May;39(4):275-278. doi: 10.1089/jop.2022.0156. Epub 2023 Mar 21.

    PMID: 36944128DERIVED

MeSH Terms

Conditions

Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesDry Eye SyndromesLacrimal Apparatus Diseases

Study Officials

  • Steffen Heegaard, MD, DMSc

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 4, 2020

Study Start

November 3, 2020

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)