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Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease

Primary Purpose

Mesenchymal Stem Cell, Dry Eye Syndromes

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
MSCs eye drops
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesenchymal Stem Cell

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    experimental group

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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
    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.

    Full Information

    First Posted
    February 21, 2023
    Last Updated
    March 13, 2023
    Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05784519
    Brief Title
    Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease
    Official Title
    Clinical Study of Mesenchymal Stem Cell Eye Drops for Treating Dry Eye Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mesenchymal Stem Cell, Dry Eye Syndromes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    The MSCs eye drops was administered to enrolled patients with 5×10^5 /50μl in each eye, twice a day for 2 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    MSCs eye drops
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The change of OSDI score
    Description
    OSDI questionnaire: It was divided into 3 dimensions, including ocular symptoms, visual function, and environmental factors. The total score is less than 13.
    Time Frame
    1 week
    Title
    The change of Schirmer test
    Description
    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.
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Tear break-up time
    Description
    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
    Time Frame
    1 week
    Title
    Fluorescein sodium staining of the ocular surface.
    Description
    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.
    Time Frame
    1 week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. 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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    kai Hu, doctor
    Phone
    +86 13951606283
    Email
    kai_hu@nju.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease

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