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Mesenchymal Stem CellEarly Phase 1NCT05784519

Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease

A Early Phase 1 study testing MSCs eye drops in people with Mesenchymal Stem Cell and Dry Eye Syndromes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this non-randomized, prospective, open, one-arm clinical study is to learn about the clinical efficacy of stem cell eye drops in patients with dry eye disease (DED) who failed to respond to artificial tear sodium hyaluronate eye drops three times a day for two weeks. Read more about this study

Who is it for?
Ages 40 to 60 years, women only
Conditions the study is for
Mesenchymal Stem Cell, Dry Eye Syndromes
What is being tested?
MSCs eye drops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Sep 2023to 31 Oct 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult
  1. Inclusion Criteria:
  2. As determined by the investigator, the subject is able to understand and comply with the protocol requirements;
  3. Subject or subject's legal representative (if applicable) sign and date the written informed consent or any privacy authorization document required prior to the commencement of the study process;
  4. Age 40-60;
  5. Female patients;
  6. The subject has received artificial tear sodium hyaluronate treatment with eye drops three times a day, but the treatment has no effect for two weeks, and the clinical examination results are consistent with:
  • OSDI score ≥13;
  • Schirmer test < 10mm/5min;
  • Tear break-up time < 10s;
  • Fluorescein sodium staining on the ocular surface was positive.
  1. Exclusion Criteria:
  2. Eye exclusion criteria:
  • Subjects with other eye diseases such as glaucoma, cataract, uveitis, optic neuritis, etc.；
  • The subjects had undergone eye surgery (e.g., cataract surgery) within the last three months;
  • Subjects who wear contact lenses for a long time and are unwilling to remove them in the study;
  • The subject has received eye drops in the past 24 hours that may affect the clinical study.
  1. Exclusion criteria related to infectious diseases:
  • The subject has fungal, bacterial or viral keratitis or conjunctivitis with evidence of infection;
  • The subject has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection;
  • The subject has any identified congenital or acquired immunodeficiency (e.g., common immunodeficiency, human immunodeficiency HIV infection, organ transplantation);
  • The subject has active tuberculosis (TB positive);
  • Subjects receive any live vaccine within 30 days prior to screening.
  1. Exclusion criteria for general circumstances:
  • The subject is allergic to the stem cell eye drops;
  • The subject has any unstable or uncontrolled cardiovascular, pulmonary, liver, kidney, gastrointestinal, urogenital, hematological, clotting, immunological, endocrine/metabolic, or other medical condition that the investigator deems to interfere with the study or endanger the safety of the subject;
  • Subjects had had any surgery requiring general anesthesia within 30 days prior to enrollment, or planned to have a larger procedure during the study period surgery;
  • Subjects have a history of severe neurological diseases, including stroke, multiple sclerosis, brain tumors, or neurodegenerative diseases；
  • The subjects had active psychosis, which the researchers thought might interfere with their compliance with the study process;
  • Lactating female subjects, or female subjects with positive serum pregnancy test results during the screening period, or positive urine pregnancy test results prior to study drug administration.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Drum Tower Hospital Affiliated to Nanjing University

    Nanjing

Other trials in China

About this study

Official title: Clinical Study of Mesenchymal Stem Cell Eye Drops for Treating Dry Eye Disease

The goal of this non-randomized, prospective, open, one-arm clinical study is to learn about the clinical efficacy of stem cell eye drops in patients with dry eye disease (DED) who failed to respond to artificial tear sodium hyaluronate eye drops three times a day for two weeks.

The main question aims to answer are:

  • How effective are stem cell eye drops in patients with DED?
  • How safe are stem cell eye drops for patients with DED? Participants will be treated with mesenchymal stem cells (MSCs) eye drops, 5×10^5 /50μl in each eye, twice a day for two weeks and they will be followed up for three months after treatment.
Read the detailed description

This study was mainly divided into three parts: screening period, treatment period and late treatment period. (1) Screening period: For the DED patients with artificial tear sodium hyaluronate drops three times a day and no effect for two consecutive weeks, OSDI score, fluorescein sodium stain score, tear secretion test and tear film rupture time examination were performed. 10 eligible subjects were screened out according to the inclusion/exclusion criteria, and the subjects were asked to sign informed consent. Relevant clinical examination data were collected and subjects were enrolled. 1) OSDI questionnaire: it was divided into 3 dimensions, including ocular symptoms, visual function, and environmental factors.2) Fluorescein staining score of ocular surface: After staining with 0.25% fluorescein sodium, defect staining was observed under slit lamp microscope. Cornea was scored in 3 areas: top, center and bottom. Each area was scored by 0 points (without any staining), 1 points (partial staining), 2 points (staining of more than half of the area), and 3 points (staining of the whole area). The total was divided into the sum of 3 areas. A higher score indicates more severe ocular surface damage. 3) Schirmer test: Standard tear test paper was taken and held in the conjunctival sac at 1/3 of the lower outer eyelid, and the patient was instructed to close the eyes gently. The results were observed 5 minutes later. The tear secretion test < 10mm/5min was abnormal. 4) Tear break-up time: After staining with 0.25% fluorescein sodium, patients were instructed to close their eyes under the slit lamp microscope. The tear film rupture time was calculated from the time of eye opening to the appearance of the first burst spot, and the average value was taken for three consecutive tests. The rupture time of tear film was less than 10s. (2) Treatment period: Formal clinical treatment: 10 enrolled patients received MSC eye drops twice a day for two weeks. OSDI score, ocular fluorescein sodium stain score, tear secretion test and tear film rupture time examination were performed every weekend during drug administration. Adverse events, serious adverse events and drug-related adverse events ≥Ⅲ during treatment were recorded to evaluate drug safety. (3) Late treatment: 3 months of follow-up after the end of treatment. OSDI score was performed during weekly telephone follow-up, and clinical indicators (OSDI score, fluorescein sodium staining score of ocular surface, tear secretion test and tear film rupture time test) were examined every four weeks to evaluate the treatment effect of DED.

Being tested
MSCs eye drops
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MSCs eye dropsDrug

    MSCs were used to prepare single-cell suspension, and 0.9% sodium chloride was added to balance PH value to prepare the effective, safe and stable eye drops. Giving the patient with 5×10^5 /50μl in each eye, twice a day for 2 weeks.

Study groups in NCT05784519
Study groupRoleWhat they receive
experimental groupExperimentalThe MSCs eye drops was administered to enrolled patients with 5×10^5 /50μl in each eye, twice a day for 2 weeks.
Receives: Drug: MSCs eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of OSDI score

    OSDI questionnaire: It was divided into 3 dimensions, including ocular symptoms, visual function, and environmental factors. The total score is less than 13.

    Measured: 1 week

  2. The change of Schirmer test

    Standard tear test paper was taken and held in the conjunctival sac at 1/3 of the lower eyelid, and the patient was instructed to close the eyes gently. The results were observed 5 minutes later. Schirmer test < 10mm/5min was abnormal.

    Measured: 1 week

Secondary outcomes (2)

  1. Tear break-up time

    After staining with 0.25% fluorescein sodium, patients were instructed to close their eyes under the slit lamp microscope. The tear film rupture time was calculated from the time of eye opening to the appearance of the first burst spot, and the mean value was taken for three consecutive tests. The tear film rupture time < 10s is abnormal

    Measured: 1 week

  2. Fluorescein sodium staining of the ocular surface.

    After staining with 0.25% fluorescein sodium, defect staining was observed under slit lamp microscope. Cornea was scored in 3 areas (FIG. 1) : top, center and bottom. Each area was scored according to 0 points (without any staining), 1 points (partial staining), 2 points (staining of more than half of the area) and 3 points (staining of the whole area), and the total was divided into the sum of 3 areas. A higher score indicates more severe ocular surface damage.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784519
Sponsor's protocol ID
SC202200102
Status last verified
Mar 2026
First submitted
21 Feb 2023
Last updated
15 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dana R, Bradley JL, Guerin A, Pivneva I, Stillman IO, Evans AM, Schaumberg DA. Estimated Prevalence and Incidence of Dry Eye Disease Based on Coding Analysis of a Large, All-age United States Health Care System. Am J Ophthalmol. 2019 Jun;202:47-54. doi: 10.1016/j.ajo.2019.01.026. Epub 2019 Feb 2.

    PubMed 30721689

  • Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20.

    PubMed 28736337

  • Pflugfelder SC, de Paiva CS. The Pathophysiology of Dry Eye Disease: What We Know and Future Directions for Research. Ophthalmology. 2017 Nov;124(11S):S4-S13. doi: 10.1016/j.ophtha.2017.07.010.

    PubMed 29055361

  • Oguz H. Ocular surface disease and quality of life in patients with glaucoma. Am J Ophthalmol. 2012 May;153(5):1003; author reply 1003-4. doi: 10.1016/j.ajo.2012.01.017. No abstract available.

    PubMed 22516154

  • Baudouin C. Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. Acta Ophthalmol. 2008 Nov;86(7):716-26. doi: 10.1111/j.1755-3768.2008.01250.x. Epub 2008 Jun 3.

    PubMed 18537937

  • Yamaguchi T. Inflammatory Response in Dry Eye. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES192-DES199. doi: 10.1167/iovs.17-23651.

    PubMed 30481826

  • Luo L, Li DQ, Doshi A, Farley W, Corrales RM, Pflugfelder SC. Experimental dry eye stimulates production of inflammatory cytokines and MMP-9 and activates MAPK signaling pathways on the ocular surface. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4293-301. doi: 10.1167/iovs.03-1145.

    PubMed 15557435

  • Fan NW, Dohlman TH, Foulsham W, McSoley M, Singh RB, Chen Y, Dana R. The role of Th17 immunity in chronic ocular surface disorders. Ocul Surf. 2021 Jan;19:157-168. doi: 10.1016/j.jtos.2020.05.009. Epub 2020 May 26.

    PubMed 32470612

  • Dohlman TH, Chauhan SK, Kodati S, Hua J, Chen Y, Omoto M, Sadrai Z, Dana R. The CCR6/CCL20 axis mediates Th17 cell migration to the ocular surface in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Jun 12;54(6):4081-91. doi: 10.1167/iovs.12-11216.

    PubMed 23702781

  • De Paiva CS, Chotikavanich S, Pangelinan SB, Pitcher JD 3rd, Fang B, Zheng X, Ma P, Farley WJ, Siemasko KF, Niederkorn JY, Stern ME, Li DQ, Pflugfelder SC. IL-17 disrupts corneal barrier following desiccating stress. Mucosal Immunol. 2009 May;2(3):243-53. doi: 10.1038/mi.2009.5. Epub 2009 Feb 25.

    PubMed 19242409

  • Subbarayal B, Chauhan SK, Di Zazzo A, Dana R. IL-17 Augments B Cell Activation in Ocular Surface Autoimmunity. J Immunol. 2016 Nov 1;197(9):3464-3470. doi: 10.4049/jimmunol.1502641. Epub 2016 Sep 21.

    PubMed 27655846

  • Melnikov S, Mayan H, Uchida S, Holtzman EJ, Farfel Z. Cyclosporine metabolic side effects: association with the WNK4 system. Eur J Clin Invest. 2011 Oct;41(10):1113-20. doi: 10.1111/j.1365-2362.2011.02517.x. Epub 2011 Mar 24.

    PubMed 21434893

  • Park B, Lee IS, Hyun SW, Jo K, Lee TG, Kim JS, Kim CS. The Protective Effect of Polygonum cuspidatum (PCE) Aqueous Extract in a Dry Eye Model. Nutrients. 2018 Oct 19;10(10):1550. doi: 10.3390/nu10101550.

    PubMed 30347752

  • Perry HD, Solomon R, Donnenfeld ED, Perry AR, Wittpenn JR, Greenman HE, Savage HE. Evaluation of topical cyclosporine for the treatment of dry eye disease. Arch Ophthalmol. 2008 Aug;126(8):1046-50. doi: 10.1001/archopht.126.8.1046.

    PubMed 18695097

  • de Paiva CS, Pflugfelder SC, Ng SM, Akpek EK. Topical cyclosporine A therapy for dry eye syndrome. Cochrane Database Syst Rev. 2019 Sep 13;9(9):CD010051. doi: 10.1002/14651858.CD010051.pub2.

    PubMed 31517988

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MSCs eye drops in people with Mesenchymal Stem Cell and Dry Eye Syndromes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of OSDI score (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05784519, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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