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

NCT04615455 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-08

No results posted yet for this study

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.

Conditions

  • Keratoconjunctivitis Sicca, in Sjogren's Syndrome

Interventions

DRUG

ASCs

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

DRUG

Cryostor CS10

CryoStor® CS10 freeze medium

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Steffen Heegaard, MD, DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2022-12-01
Completion
2023-01-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615455 on ClinicalTrials.gov