Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease

NCT05784519 | Active Not Recruiting Early Phase 1

• 1 other identifier: SC202200102
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mesenchymal Stem Cell; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

• 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.

  1 week

• 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.

  1 week

Secondary Outcomes (2)

• Tear break-up time

  1 week

• Fluorescein sodium staining of the ocular surface.

  1 week

Study Arms (1)

experimental group

EXPERIMENTAL

The MSCs eye drops was administered to enrolled patients with 5×10\^5 /50μl in each eye, twice a day for 2 weeks.

Drug: MSCs eye drops

Interventions

MSCs eye drops DRUG

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.

experimental group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• As determined by the investigator, the subject is able to understand and comply with the protocol requirements;
• 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;
• Age 40-60;
• Female patients;
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Drum Tower Hospital Affiliated to Nanjing University

Nanjing, China

Location

Related Publications (25)

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  PMID: 40269970 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 27, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)