NCT04213248

Brief Summary

The purpose of this study is to determine whether Umbilical Mesenchymal Stem Cells (UMSCs) derived Exosomes could alleviate dry eye symptoms in patients with chronic Graft Versus Host Diseases (cGVHD).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 21, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

December 25, 2019

Last Update Submit

February 10, 2022

Conditions

Dry Eye

Keywords

Dry eyeUMSCExosomecGVHD

Outcome Measures

Primary Outcomes (1)

  • Changes in Ocular Surface Disease Index (OSDI) Score

    The OSDI is a 12-question validated questionnaire used to measure dry eye symptoms. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a decrease over 10 scores from baseline indicates an improvement.

    3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

Secondary Outcomes (6)

  • Changes in tear secretion amount by Schirmer's Test

    3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • Changes in Tear break time

    3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • Changes in Ocular Surface Staining

    3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • Changes in best corrected visual acuity (BCVA).

    3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • Changes in conjunctiva redness score

    3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • +1 more secondary outcomes

Study Arms (1)

UMSC-exo treatment

EXPERIMENTAL

Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by UMSC-exo intervention for 2 weeks.

Drug: Umbilical Mesenchymal Stem Cells derived Exosomes

Interventions

Umbilical Mesenchymal Stem Cells derived ExosomesDRUG

Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by UMSC-exo 10ug/drop, four times a day for 14 days. The follow-up visit will be 12 weeks.

Also known as: UMSC-exo
UMSC-exo treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed cGVHD with apparent dry eye symptoms by intern specialists and ophthalmologists, and previous application of artificial tears could not relieve the dry eye symptoms.
  • And meet the following standards:
  • have the following symptoms in at least one eye: dryness, burning sensation, foreign body sensation, discomfort in the ocular surface or visual fatigue;
  • tear secretion test (Schirmer's Test) of either eye ≤ 10 mm / 5 min;
  • the corneal fluorescein staining score (CFS) was more than 4;
  • Tear break time (TBUT) is less than 10 seconds.

You may not qualify if:

  • Those who are allergic to any component of the drug in this study;
  • Pregnant or nursing women;
  • Patients with active fungal, bacterial or viral keratitis or conjunctivitis;
  • have serious heart, lung, liver or kidney diseases;
  • Other incurable ocular diseases before the study; such as glaucoma, uveitis, retinitis pigmentosa.
  • Wearing contact lenses and unwilling to take off in the study;
  • Performed ocular surgery (including cataract surgery) in recent three months;
  • Enrolled in other interventional clinical studies at the same time;
  • Application of eye drops that might affect the clinical study in the past 24 hours;
  • Unable to complete the study according to the investigators' requirements;
  • Serious systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Randall Harrell C, Djonov V, Volarevic A, Arsenijevic A, Volarevic V. Mesenchymal Stem Cell-Sourced Exosomes as Potentially Novel Remedies for Severe Dry Eye Disease. J Ophthalmol. 2025 Jan 10;2025:5552374. doi: 10.1155/joph/5552374. eCollection 2025.

    PMID: 39839752DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Xialin Liu, Prof.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Zhou

CONTACT

(020)66615460zhoutian@gzzoc.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2019

First Posted

December 30, 2019

Study Start

February 21, 2020

Primary Completion

May 18, 2023

Study Completion

December 1, 2023

Last Updated

February 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)