Safety and Efficacy of Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops Treatment for Dry Eye Diseases Post Refractive Surgery and Associated With Blepharospasm
NCT05738629 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2023-02-22
Summary
The purpose of this study is to evaluate the preliminary safety and effectiveness of Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops in the treatment of dry eye diseases post refractive surgery and associated with blepharospasm
Conditions
Interventions
- DRUG
-
Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops
Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by PSC-MSC-Exo eye drops 0.125 ml/single eye/one time, four times a day for 12 weeks. The follow-up visit will be 12 weeks since the administration of PSC-MSC-Exo eye drops.
Sponsors & Collaborators
-
Zhejiang University
collaborator OTHER -
Hangzhou yuansheng biotechnology Co., Ltd
collaborator UNKNOWN -
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Principal Investigators
-
Juan Ye, Doc. · 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2025-02-28
- Completion
- 2025-02-28
Countries
- China
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