Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease

• Status: Not yet recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Treatments: Ophthalmic Solutions

Criteria

1. Inclusion Criteria:

1. As determined by the investigator, the subject is able to understand and comply with the protocol requirements;

2. 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;

3. Age 40-60;

4. Female patients;

5. 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.

2. Exclusion Criteria:

1. 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.

2. 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.

3. 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.