NCT05784519

Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mesenchymal Stem Cell
• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	MSCs eye drops	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2028-07-31
• Completion: 2028-10-31
• First posted: 2023-03-27
• Last updated: 2026-04-15

Locations

1 site across 1 country: China